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Perni S, Jimenez R, Jagsi R. Optimizing Informed Consent in Cancer Clinical Trials. Semin Radiat Oncol 2023; 33:349-357. [PMID: 37684064 DOI: 10.1016/j.semradonc.2023.06.001] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 09/10/2023]
Abstract
The concept of informed consent has evolved considerably over the course of the 20th century, leading to its establishment as a foundational ethical principle for the conduct of biomedical research in the United States. Even though it is now a highly regulated part of cancer research, the process of obtaining informed consent is often impeded by systemic, clinician, and patient factors that require both small- and large-scale intervention. New challenges and considerations continue to emerge due to innovations in clinical trial design, increases in utilization of genomic sequencing, and advances in genomic editing and artificial intelligence. We present a review of the history, policy, pragmatic challenges, and evolving role of the central ethical tenet of informed consent in clinical trials.
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Affiliation(s)
- Subha Perni
- Division of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX
| | - Rachel Jimenez
- Department of Radiation Oncology, Massachusetts General Hospital, Boston, MA
| | - Reshma Jagsi
- Department of Radiation Oncology, Winship Cancer Institute of Emory University, Atlanta, GA.
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McClary T, Blee S, Avinger A, Dai Q, Switchenko J, Dixon M, Pentz R. Accounting for the High Enrollment of African Americans on Winship Cancer Institute's Myeloma Clinical Trials. ETHICS, MEDICINE, AND PUBLIC HEALTH 2023; 27:100877. [PMID: 37007841 PMCID: PMC10062432 DOI: 10.1016/j.jemep.2023.100877] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 03/06/2023]
Abstract
Background Thirty-four percent of Multiple Myeloma (MM) clinical trial participants at Winship Cancer Institute (Winship) are African American (AA); however, AAs make up only 4.5 percent of myeloma clinical trial participants in the United States. Given our high enrollment, we aimed to measure AAs' trust in providers and identify if clinical trial enrollment barriers exist. Methodology A member of the ethics research team surveyed AA patients who had consented to a MM clinical trial at Winship. Three validated surveys were used: Trust in Medical Research (TMR); Human Connection (THC) which measures how much patients feel they are heard and valued by their physicians; and the Duke Intrinsic Religiosity Scale (DUREL) which measures strength of religious engagement and belief. The survey also included questions about the impact of side effects, distance to the trial center and trial related costs on the decision to participate in clinical trial. Results Ninety-two percent (61/67) of patients approached consented. The mean TMR score and the mean THC score were significantly higher (P-value < 0.001) than the results obtained in key national surveys (TMR 14.9 compared to 11.65; THC 57.7 compared to 54.6). These two surveys were significantly correlated, meaning trust and human connection increase or decrease in tandem. The 3 religiosity subscale results showed high religiosity (3.84, 4.36, and 4.35 with 5 being the highest score). The mean scores of the importance of the investigational agent's side effects, trial costs, and distance to trial center on the decision to enroll in a clinical trial were also high (8.5, 7.8, and 6.5, respectively, with 10 being the most important). Conclusion In our study population, high trust and human connection overcame other trial participation barriers: strong religious beliefs and concerns about side effects, costs, and travel distance. We present a roadmap to guide investigators to increase human connection, and hopefully trust.
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Affiliation(s)
- T.S. McClary
- Emory University, Winship Cancer Institute, 1365, Clifton Road, 30322 Atlanta, GA, USA
- South University Orlando Campus5900 Lake Ellenor Dr, Orlando Fl 32809
| | - S.M. Blee
- Emory University, Winship Cancer Institute, 1365, Clifton Road, 30322 Atlanta, GA, USA
- Creighton University Medical School2621 Burt Street, Omaha, Nebraska 68178
| | - A.M. Avinger
- Emory University, Winship Cancer Institute, 1365, Clifton Road, 30322 Atlanta, GA, USA
- Wake Forest University School of Medicine, 475 Vine St, Winston-Salem, NC 27101
| | - Q. Dai
- School of Public Health, Emory University Rollins, 1518, Clifton Road, 30322 Atlanta, GA, USA
| | - J. Switchenko
- School of Public Health, Emory University Rollins, 1518, Clifton Road, 30322 Atlanta, GA, USA
| | - M.D. Dixon
- Emory University, Winship Cancer Institute, 1365, Clifton Road, 30322 Atlanta, GA, USA
| | - R.D. Pentz
- Emory University, Winship Cancer Institute, 1365, Clifton Road, 30322 Atlanta, GA, USA
- Emory University School of Medicine, 100, Woodruff Circle, 30322 Atlanta, GA, USA
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Shah KS, Reyes-Miranda AE, Bradley SM, Breathett K, Das SR, Gluckman TJ, Gupta D, Leung DT, Mutharasan RK, Peterson PN, Spivak ES, Shah RU. Clinical Trial Participation and COVID-19: a Descriptive Analysis from the American Heart Association's Get With The Guidelines Registry. J Racial Ethn Health Disparities 2023; 10:892-898. [PMID: 35380371 PMCID: PMC8982302 DOI: 10.1007/s40615-022-01277-8] [Citation(s) in RCA: 2] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/21/2021] [Revised: 02/13/2022] [Accepted: 02/28/2022] [Indexed: 10/31/2022]
Abstract
As COVID-19 cases begin to decrease in the USA, learning from the pandemic experience will provide insights regarding disparities of care delivery. We sought to determine if specific populations hospitalized with COVID-19 are equally likely to be enrolled in clinical trials. We examined patients hospitalized with COVID-19 at centers participating in the American Heart Association's COVID-19 CVD Registry. The primary outcome was odds of enrollment in a clinical trial, according to sex, race, and ethnicity. Among 14,397 adults hospitalized with COVID-19, 9.5% (n = 1,377) were enrolled in a clinical trial. The proportion of enrolled patients was the lowest for Black patients (8%); in multivariable analysis, female and Black patients were less likely to be enrolled in a clinical trial related to COVID-19 compared to men and other racial groups, respectively. Determination of specific reasons for the disparities in trial participation related to COVID-19 in these populations should be further investigated.
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Affiliation(s)
- Kevin S Shah
- Division of Cardiovascular Medicine, Department of Internal Medicine, University of Utah School of Medicine, 30 N. 1900 E, Room 4A100, UT, 84132, Salt Lake City, USA.
| | - Adriana E Reyes-Miranda
- Division of Cardiovascular Medicine, Department of Internal Medicine, University of Utah School of Medicine, 30 N. 1900 E, Room 4A100, UT, 84132, Salt Lake City, USA
| | - Steven M Bradley
- Minneapolis Heart Institute and Minneapolis Heart Institute Foundation, Minneapolis, MN, USA
| | - Khadijah Breathett
- Division of Cardiovascular Medicine, Sarver Heart Center, University of Arizona, Tucson, AZ, USA
| | - Sandeep R Das
- Department of Internal Medicine, Cardiology Division, University of Texas Southwestern Medical Center, Dallas, TX, USA
| | - Ty J Gluckman
- Center for Cardiovascular Analytics, Research and Data Science (CARDS), Providence Heart Institute, Portland, OR, USA
| | - Divya Gupta
- Division of Cardiology, Emory University School of Medicine, Atlanta, GA, USA
| | - Daniel T Leung
- Division of Infectious Diseases, University of Utah School of Medicine, Salt Lake City, UT, USA
| | - R Kannan Mutharasan
- Division of Cardiology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA
| | - Pamela N Peterson
- Denver Health Medical Center, Denver, CO, USA
- University of Colorado Anschutz Medical Center, Aurora, CO, USA
| | - Emily S Spivak
- Division of Infectious Diseases, University of Utah School of Medicine, Salt Lake City, UT, USA
| | - Rashmee U Shah
- Division of Cardiovascular Medicine, Department of Internal Medicine, University of Utah School of Medicine, 30 N. 1900 E, Room 4A100, UT, 84132, Salt Lake City, USA
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4
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Hue JJ, Katayama ES, Markt SC, Elshami M, Saltzman J, Bajor D, Hosmer A, Mok S, Dumot J, Ammori JB, Rothermel LD, Hardacre JM, Winter JM, Ocuin LM. A nationwide analysis of pancreatic cancer trial enrollment reveals disparities and participation problems. Surgery 2022; 172:257-264. [PMID: 34839935 DOI: 10.1016/j.surg.2021.10.023] [Citation(s) in RCA: 6] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/22/2021] [Revised: 08/22/2021] [Accepted: 10/08/2021] [Indexed: 01/02/2023]
Abstract
BACKGROUND Our research group recently surveyed the clinical trial landscape in pancreatic adenocarcinoma and identified 430 active trials. These represent an opportunity to expand treatment options for patients with pancreatic adenocarcinoma. Our primary objective was to detail clinical trial participation among patients with pancreatic adenocarcinoma. Our secondary objective was to evaluate survival. METHODS We queried the National Cancer Database (2004-2016) for patients with pancreatic adenocarcinoma. Patients were stratified by trial participation: clinical trial or non-trial. Multivariable logistic regression was used to identify variables associated with trial participation. The Kaplan-Meier method and multivariable Cox hazards regression were used to analyze survival. RESULTS In total, 261,483 patients were included: 1,110 (0.4%) were enrolled in a clinical trial. A total of 57 Black patients participated in a clinical trial (0.19% of Black patients). This was lower compared to White patients (n = 955, 0.49% of White patients, P < .001). After adjusting for demographic and clinical factors, Black patients were less likely to be enrolled in a clinical trial (odds ratio = 0.387, P < .001). Patients treated at nonacademic medical centers were less likely to be in a clinical trial. Trial participation was associated with an increased median survival relative to non-trial patients (stage IV: 9.0 vs 3.8 months, P < .001), and this association remained on multivariable regression (hazard ratio = 0.779, P < .001). CONCLUSION Fewer than 1% of patients with pancreatic adenocarcinoma participated in a clinical trial. There are racial and sociodemographic disparities in clinical trial enrollment. An association was observed between clinical trial participants and prolonged survival.
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Affiliation(s)
- Jonathan J Hue
- Department of Surgery, Division of Surgical Oncology, University Hospitals Cleveland Medical Center, OH
| | | | - Sarah C Markt
- Department of Population and Quantitative Health Sciences, Case Western Reserve University School of Medicine, Cleveland, OH
| | - Mohamedraed Elshami
- Department of Surgery, Division of Surgical Oncology, University Hospitals Cleveland Medical Center, OH
| | - Joel Saltzman
- Department of Medicine, Division of Medical Oncology, University Hospitals Cleveland Medical Center, OH
| | - David Bajor
- Department of Medicine, Division of Medical Oncology, University Hospitals Cleveland Medical Center, OH
| | - Amy Hosmer
- Department of Medicine, Division of Gastroenterology, University Hospitals Cleveland Medical Center, OH
| | - Shaffer Mok
- Department of Medicine, Division of Gastroenterology, University Hospitals Cleveland Medical Center, OH
| | - John Dumot
- Department of Medicine, Division of Gastroenterology, University Hospitals Cleveland Medical Center, OH
| | - John B Ammori
- Department of Surgery, Division of Surgical Oncology, University Hospitals Cleveland Medical Center, OH
| | - Luke D Rothermel
- Department of Surgery, Division of Surgical Oncology, University Hospitals Cleveland Medical Center, OH
| | - Jeffrey M Hardacre
- Department of Surgery, Division of Surgical Oncology, University Hospitals Cleveland Medical Center, OH
| | - Jordan M Winter
- Department of Surgery, Division of Surgical Oncology, University Hospitals Cleveland Medical Center, OH
| | - Lee M Ocuin
- Department of Surgery, Division of Surgical Oncology, University Hospitals Cleveland Medical Center, OH.
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Midthun L, Kim S, Hendifar A, Osipov A, Klempner SJ, Chao J, Cho M, Guan M, Placencio-Hickok VR, Gangi A, Burch M, Lin DC, Waters K, Atkins K, Kamrava M, Gong J. Chemotherapy predictors and a time-dependent chemotherapy effect in metastatic esophageal cancer. World J Gastrointest Oncol 2022; 14:511-524. [PMID: 35317320 PMCID: PMC8919005 DOI: 10.4251/wjgo.v14.i2.511] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/16/2021] [Revised: 07/01/2021] [Accepted: 12/25/2021] [Indexed: 02/06/2023] Open
Abstract
BACKGROUND Chemotherapy has long been shown to confer a survival benefit in patients with metastatic esophageal cancer. However, not all patients with metastatic disease receive chemotherapy.
AIM To evaluate a large cancer database of metastatic esophageal cancer cases to identify predictors of receipt to chemotherapy and survival.
METHODS We interrogated the National Cancer Database (NCDB) between 2004-2015 and included patients with M1 disease who had received or did not receive chemotherapy. A logistic regression model was used to examine the associations between chemotherapy and potential confounders and a Cox proportional hazards model was employed to examine the effect of chemotherapy on overall survival (OS). Propensity score analyses were further performed to balance measurable confounders between patients treated with and without chemotherapy.
RESULTS A total of 29182 patients met criteria for inclusion in this analysis, with 21911 (75%) receiving chemotherapy and 7271 (25%) not receiving chemotherapy. The median follow-up was 69.45 mo. The median OS for patients receiving chemotherapy was 9.53 mo (9.33-9.72) vs 2.43 mo (2.27-2.60) with no chemotherapy. Year of diagnosis 2010-2014 [odds ratio (OR): 1.29, 95% confidence interval (CI): 1.17-1.43, P value < 0.001], median income > $46000 (OR: 1.49, 95%CI: 1.27-1.75, P value < 0.001), and node-positivity (OR: 1.35, 95%CI: 1.20-1.52, P < 0.001) were independent predictors of receiving chemotherapy, while female gender (OR: 0.86, 95%CI: 0.76-0.98, P = 0.019), black race (OR: 0.76, 95%CI: 0.67-0.93, P = 0.005), uninsured status (OR: 0.41, 95%CI: 0.33-0.52, P < 0.001), and high Charlson Comorbidity Index (CCI) (OR for CCI ≥ 2: 0.61, 95%CI: 0.50-0.74, P < 0.001) predicted for lower odds of receiving chemotherapy. Modeling the effect of chemotherapy on OS using a time-dependent coefficient showed that chemotherapy was associated with improved OS up to 10 mo, after which there is no significant effect on OS. Moreover, uninsured status [hazard ratio (HR): 1.20, 95%CI: 1.09-1.31, P < 0.001], being from the geographic Midwest (HR: 1.07, 95%CI: 1.01-1.14, P = 0.032), high CCI (HR for CCI ≥ 2: 1.16, 95%CI: 1.07-1.26, P < 0.001), and higher tumor grade (HR for grade 3 vs grade 1: 1.28, 95%CI: 1.14-1.44, P < 0.001) and higher T stage (HR for T1 vs T4: 0.89, 95%CI: 0.84-0.95, P < 0.001) were independent predictors of worse OS on multivariable analyses.
CONCLUSION In this large, retrospective NCDB analysis, we identified several socioeconomic and clinicopathologic predictors for receiving chemotherapy and OS in patients with metastatic esophageal cancer. The benefit of chemotherapy on OS is time-dependent and favors early initiation. Focused outreach in lower income and underinsured patients is critical as receipt of chemotherapy is associated with improved OS.
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Affiliation(s)
- Lauren Midthun
- Department of Medicine, Division of Hematology and Oncology, Cedars-Sinai Medical Center, Los Angeles, CA 90048, United States
| | - Sungjin Kim
- Biostatistics and Bioinformatics Research Center, Cedars Sinai Medical Center, Los Angeles, CA 90048, United States
| | - Andrew Hendifar
- Samuel Oschin Cancer Center, Cedars-Sinai Medical Center, Los Angeles, CA 90048, United States
| | - Arsen Osipov
- Department of Medicine, Division of Hematology and Oncology, Cedars-Sinai Medical Center, Los Angeles, CA 90048, United States
| | - Samuel J Klempner
- Department of Medicine, Beth Israel Deaconess Medical Center/Harvard Medical School, Brigham and Women's Hospital/Harvard Medical School, Boston, MA 02114, United States
| | - Joseph Chao
- Department of Medical Oncology and Therapeutics Research, City of Hope Comprehensive Cancer Center, Duarte, CA 91010, United States
| | - May Cho
- Division of Hematology and Oncology, Department of Medicine, University of California, Irvine, CA 92697, United States
| | - Michelle Guan
- Department of Medicine, Division of Hematology and Oncology, Cedars-Sinai Medical Center, Los Angeles, CA 90048, United States
| | | | - Alexandra Gangi
- Department of Surgery, Cedars-Sinai Medical Center, Los Angeles, CA 90048, United States
| | - Miguel Burch
- Department of Surgery, Cedars-Sinai Medical Center, Los Angeles, CA 90048, United States
| | - De-Chen Lin
- Department of Medicine, Division of Hematology and Oncology, Cedars-Sinai Medical Center, Los Angeles, CA 90048, United States
| | - Kevin Waters
- Department of Pathology and Laboratory Medicine, Cedars Sinai Medical Center, Los Angeles, CA 90048, United States
| | - Katelyn Atkins
- Department of Radiation Oncology, Cedars Sinai Medical Center, Los Angeles, CA 90048, United States
| | - Mitchell Kamrava
- Department of Radiation Oncology, Cedars-Sinai Medical Center, Los Angeles, CA 90048, United States
| | - Jun Gong
- Department of Medicine, Division of Hematology and Oncology, Cedars-Sinai Medical Center, Los Angeles, CA 90048, United States
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Racial and Ethnic Diversity in SARS-CoV-2 Vaccine Clinical Trials Conducted in the United States. Vaccines (Basel) 2022; 10:vaccines10020290. [PMID: 35214748 PMCID: PMC8875029 DOI: 10.3390/vaccines10020290] [Citation(s) in RCA: 17] [Impact Index Per Article: 5.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/04/2021] [Revised: 12/28/2021] [Accepted: 01/11/2022] [Indexed: 12/20/2022] Open
Abstract
Evidence shows that White and non-Hispanic individuals are overrepresented in clinical trials. The development of new vaccines and drugs, however, necessitates that clinical research trials include representative participants, particularly in light of evidence showing that underrepresented minorities may have a different response to certain medications and vaccines. Racial and ethnic disparities among clinical trials are multilayered and complex, and this requires action. The results of this study indicate that significant racial and ethnic disparities consistently exist among the most recent early SARS-CoV-2 vaccine clinical trials as compared to the pandemic H1N1 vaccine clinical trials of 2009. New strategies, policies, training programs, and reforms are required to address these disparities among clinical trials.
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Margevicius S, Daly B, Schluchter M, Flocke S, Manne S, Surdam J, Fulton S, Meropol NJ. Randomized trial of a web-based nurse education intervention to increase discussion of clinical trials. Contemp Clin Trials Commun 2021; 22:100789. [PMID: 34169174 PMCID: PMC8209078 DOI: 10.1016/j.conctc.2021.100789] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/22/2020] [Revised: 03/29/2021] [Accepted: 05/16/2021] [Indexed: 11/15/2022] Open
Abstract
Background Clinical trials are a critical source of evidence for oncology care, yet very few patients participate. Among healthcare providers, nurses spend the most time with cancer patients and are the most highly trusted professionals. We developed and evaluated an educational program for oncology nurses targeting knowledge, attitudes, self-efficacy and perceived norms to facilitate discussion about clinical trials and support patient decision making. Methods A nationwide sample of oncology nurses were randomly assigned to receive general clinical trials education delivered as text (attention control) vs. tailored video vignettes (intervention) in a web-based continuing education program. Participants completed a baseline assessment and follow up assessments immediately after the educational program and three months later. The primary outcome was intention to discuss clinical trials with patients. Secondary outcomes were knowledge and attitudes about clinical trials, self-efficacy, and perceived norms. Results 1393 nurses enrolled and completed the educational program and post-intervention assessment (720 control, 673 video). Both text education and tailored video education increased intention to discuss clinical trials with patients, with a greater effect in the video group (p < .0001). Likewise, knowledge, attitudes, perceived behavioral control, and perceived norms were all improved with education in both groups, and the magnitude of benefit was greater (p < .001) for the video group in all outcomes except knowledge. Conclusion A one-time online educational program for oncology nurses improves knowledge, attitudes, self-efficacy and intention to engage patients in discussions about clinical trials. A tailored video format was associated with a greater effect than standard text only material.
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Affiliation(s)
- Seunghee Margevicius
- Department of Population and Quantitative Health Sciences, School of Medicine, Case Western Reserve University, Cleveland, OH, USA.,Case Comprehensive Cancer Center, Case Western Reserve University, Cleveland, OH, USA
| | - Barbara Daly
- Case Comprehensive Cancer Center, Case Western Reserve University, Cleveland, OH, USA.,Frances Payne Bolton School of Nursing, Case Western Reserve University, Cleveland, OH, USA
| | - Mark Schluchter
- Department of Population and Quantitative Health Sciences, School of Medicine, Case Western Reserve University, Cleveland, OH, USA
| | - Susan Flocke
- Department of Family Medicine, Oregon Health and Science University, Portland, OR, USA
| | | | - Jessica Surdam
- University Hospitals Connor Integrative Health Network, Cleveland Medical Center, Cleveland, OH, USA
| | - Sarah Fulton
- Begun Center for Violence Prevention Research and Education, Case Western Reserve University, Cleveland, OH, USA
| | - Neal J Meropol
- Case Comprehensive Cancer Center, Case Western Reserve University, Cleveland, OH, USA.,Flatiron Health, New York, NY, USA
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Langford AT, Hawley ST, Stableford S, Studts JL, Byrne MM. Development of a Plain Language Decision Support Tool for Cancer Clinical Trials: Blending Health Literacy, Academic Research, and Minority Patient Perspectives. JOURNAL OF CANCER EDUCATION : THE OFFICIAL JOURNAL OF THE AMERICAN ASSOCIATION FOR CANCER EDUCATION 2020; 35:454-461. [PMID: 30739270 PMCID: PMC9575516 DOI: 10.1007/s13187-019-1482-5] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 05/25/2023]
Abstract
Despite the promise of clinical trials for improving cancer care, less than 5% of all cancer patients participate. Racial/ethnic minorities continue to be underrepresented in cancer clinical trials (CCTs). To address this gap, we developed a plain language, web-based decision support tool (CHOICES DST) in English and Spanish to support decision-making about CCTs among Blacks and Hispanics. In phase 1 (information collection), we conducted qualitative interviews with 45 cancer patients, completed a thorough literature review, and reviewed results from a telephone survey of 1100 cancer patients. In phase 2 (content generation), we created the first iteration of the CHOICES DST. In phase 3 (usability testing), we gathered user experience and acceptability data from a small sample of cancer survivors (n = 9). The Knowledge, Empowerment, and Values Clarification (KEV) model of decision-making was developed based on data from phase 1. The KEV model and other phase 1 data allowed us to create the CHOICES DST platform. Usability testing of the CHOICES DST showed highly favorable responses from users, satisfaction with content, ease of navigation, and a desire to use the tool. Qualitative results identified addressable points that would benefit from content and navigation-related alterations. The final version of the CHOICES DST was well received and understood by Black and Hispanic participants, and adheres to the mandates for plain language communication. This research provides preliminary data that CHOICES DST holds promise for improving knowledge of CCTs and potentially improving informed decision-making about participation in trials.
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Affiliation(s)
- Aisha T Langford
- Department of Population Health, New York University School of Medicine, 227 East 30th Street, Room 645, New York, NY, 10016, USA.
| | - Sarah T Hawley
- Ann Arbor VA Center of Excellence in Health Services Research & Development, University of Michigan Departments of Internal Medicine and Health Management & Policy, 2800 Plymouth Road, NCRC Building 16, 4th Floor, Ann Arbor, MI, 48109, USA
| | - Sue Stableford
- Health Literacy, Plain Language, & Clear Health Communication Consultant, Brunswick, ME, USA
| | - Jamie L Studts
- Department of Behavioral Science, University of Kentucky College of Medicine, 127 Medical Behavioral Science Building, Lexington, KY, 40536-0086, USA
| | - Margaret M Byrne
- Department of Health Outcomes and Behavior, Moffitt Cancer Center, 4117 E Fowler St., Tampa, FL, 33612, USA
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9
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The influence of race and socioeconomic status on therapeutic clinical trial screening and enrollment. J Neurooncol 2020; 148:131-139. [DOI: 10.1007/s11060-020-03503-x] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/05/2020] [Accepted: 04/17/2020] [Indexed: 10/24/2022]
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10
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Nitecki R, Bercow AS, Gockley AA, Lee H, Penson RT, Growdon WB. Clinical trial participation and aggressive care at the end of life in patients with ovarian cancer. Int J Gynecol Cancer 2020; 30:201-206. [PMID: 31911533 DOI: 10.1136/ijgc-2019-000851] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/20/2019] [Revised: 11/05/2019] [Accepted: 11/14/2019] [Indexed: 11/04/2022] Open
Abstract
OBJECTIVES In non-gynecologic cancers, clinical trial participation has been associated with aggressive care at the end of life. The objective of this investigation was to examine how trial participation affects end of life outcomes in patients with ovarian cancer. METHODS In a retrospective review of women diagnosed with ovarian cancer at our institution between January 2010 and December 2015, we collected variables identified by the National Quality Forum as measures of aggressive end of life care including chemotherapy in the last 14 days of life, intensive care unit (ICU) admission in the last 30 days of life, or death in the acute care setting. Trials investigating medications but not surgical interventions were included. The primary outcome of this study was the association between trial participation and the National Quality Forum measures of aggressive end of life care in ovarian cancer decedents. Data were analyzed with univariable and multivariable parametric and non-parametric testing, and time to event outcomes were analyzed using the Kaplan-Meier method and Cox's proportional hazard models. RESULTS Among 391 women treated for ovarian cancer, 62 patients (16%) participated in a clinical trial. Patients enrolled in clinical trials were more likely to have chemotherapy administered within 14 days of death; however, no association was found with other metrics of aggressive care at the end of life including the initiation of a new chemotherapy regimen in the last 30 days of life, ICU admissions, and death in an acute care setting. Among patients with recurrent ovarian cancer, median overall survival for trial participants was 57 months compared with only 31 months in non-trial participants (p<0.001). CONCLUSIONS In patients with ovarian cancer, clinical trial enrollment is associated with chemotherapy administration within 14 days of death, but not other measures of aggressive care at the end of life. Given the importance of clinical trial participation in improving care for women with ovarian cancer, this study suggests that concerns regarding aggressive care prior to death should not limit clinical trial participation.
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Affiliation(s)
- Roni Nitecki
- Department of Obstetrics and Gynecology, Massachusetts General Hospital, Boston, Massachusetts, USA .,Obstetrics and Gynecology, Brigham and Women's Hospital, Boston, Massachusetts, USA
| | - Alexandra S Bercow
- Department of Obstetrics and Gynecology, Massachusetts General Hospital, Boston, Massachusetts, USA.,Obstetrics and Gynecology, Brigham and Women's Hospital, Boston, Massachusetts, USA
| | - Allison A Gockley
- Gynecologic Oncology, Brigham and Women's Hospital, Boston, Massachusetts, USA
| | - Hang Lee
- Department of Medicine, MGH Biostatistics Center, Massachusetts General Hospital, Boston, Massachusetts, USA
| | - Richard T Penson
- Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA
| | - Whitfield B Growdon
- Division of Gynecologic Oncology, Vincent Obstetrics and Gynecology, Massachusetts General Hospital, Boston, Massachusetts, USA
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11
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Ellis SD, Geana M, Mackay CB, Moon DJ, Gills J, Zganjar A, Brekke G, Thrasher JB, Griebling TL. Science in the Heartland: Exploring determinants of offering cancer clinical trials in rural-serving community urology practices. Urol Oncol 2019; 37:529.e9-529.e18. [PMID: 30935846 PMCID: PMC6661185 DOI: 10.1016/j.urolonc.2019.03.004] [Citation(s) in RCA: 10] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/19/2018] [Revised: 01/24/2019] [Accepted: 03/10/2019] [Indexed: 12/30/2022]
Abstract
OBJECTIVE Engaging community urologists in referring patients to clinical trials could increase the reach of cancer trials and, ultimately, alleviate cancer disparities. We sought to identify determinants of referring patients to clinical trials among urology practices serving rural communities. METHODS We conducted semistructured qualitative interviews based on the Theoretical Domains Framework at nonmetropolitan urology practices located in communities offering urological cancer trials. Participants were asked to consider barriers and strategies that might support engaging their patients in discussions about urological cancer clinical trials and referring them appropriately. Recorded interviews were transcribed and coded using template analysis. RESULTS Most participants were not aware of available trials and had no experience with trial referral. Overall, participants held positive attitudes toward clinical trials and recognized their potential roles in accrual, but limited local resources reduced opportunities for offering trials. Most participants expressed a need for increased human, financial, and other resources to support this role. Many participants requested information and training to increase their knowledge of clinical trials and confidence in offering them to patients. Participants highlighted the need to build efficient pathways to identify available trials, match eligible patients, and facilitate communication and collaboration with cancer centers for patient follow-up and continuity of care. CONCLUSIONS With adequate logistical and informational support, community urology practices could play an important role in clinical trial accrual, advancing cancer research and increasing treatment options for rural cancer patients. Future studies should explore the effectiveness of strategies to optimize urology practices' role in clinical trial accrual.
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Affiliation(s)
- Shellie D Ellis
- Department of Health Policy & Management, University of Kansas School of Medicine, Kansas City, KS; University of Kansas Cancer Center, Kansas City, KS.
| | - Mugur Geana
- School of Journalism and Mass Communications, University of Kansas, Lawrence, KS; University of Kansas Cancer Center, Kansas City, KS
| | - Christine B Mackay
- Department of Health Policy & Management, University of Kansas School of Medicine, Kansas City, KS; University of Kansas Cancer Center, Kansas City, KS
| | - Deborah J Moon
- Department of Health Policy & Management, University of Kansas School of Medicine, Kansas City, KS
| | - Jessie Gills
- Department of Urology, Louisiana State University, New Orleans, LA
| | - Andrew Zganjar
- Department of Urology, University of Kansas School of Medicine, Kansas City, KS
| | - Gayle Brekke
- Department of Health Policy & Management, University of Kansas School of Medicine, Kansas City, KS
| | - J Brantley Thrasher
- Department of Urology, University of Kansas School of Medicine, Kansas City, KS
| | - Tomas L Griebling
- Department of Urology, University of Kansas School of Medicine, Kansas City, KS; The Landon Center on Aging, Kansas University Medical Center, Kansas City, KS
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Neil JM, Gough A, Kee F, George TJ, Pufahl J, Krieger JL. The Influence of Patient Identification and Narrative Transportation on Intentions to Participate in Cancer Research. JOURNAL OF CANCER EDUCATION : THE OFFICIAL JOURNAL OF THE AMERICAN ASSOCIATION FOR CANCER EDUCATION 2019; 34:725-734. [PMID: 29721780 PMCID: PMC7055730 DOI: 10.1007/s13187-018-1364-2] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 05/24/2023]
Abstract
Cancer decision-making interventions commonly utilize narratives as a persuasive strategy to increase identification with the message source, promote involvement with the topic, and elicit greater willingness to adopt recommended behaviors. However, there is little empirical research examining the mechanisms underlying the effectiveness of this strategy in the context of cancer research participation. Data for the current manuscript were collected as part of a larger study conducted with cancer patients (N = 413) from the USA, UK, and the Republic of Ireland. Participants viewed and evaluated video-recorded vignettes, illustrating different strategies for discussing clinical trials participation with family members. Results showed nationality was a significant predictor of identification with the main character (i.e., patient) in the vignette. Unexpectedly, these cross-national differences in identification disappeared when patients currently undergoing treatment had higher perceived susceptibility of their cancer. Identification with the main character in the vignettes was a significant predictor of intentions to participate in cancer research, but only when the mediating role of narrative transportation was considered. The findings demonstrate the importance of considering how individual and social identities influence identification with characters in cancer narratives and yield practical guidance for developing arts-based interventions to increase cancer research participation.
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Affiliation(s)
- Jordan M Neil
- Mongan Institute Health Policy Center, Harvard Medical School/Massachusetts General Hospital, Boston, MA, USA.
| | - Aisling Gough
- United Kingdom Clinical Research Collaboration Centre of Excellence in Public Health Northern Ireland, School of Medicine, Dentistry & Biomedical Sciences, Queen's University Belfast, Belfast, UK
| | - Frank Kee
- United Kingdom Clinical Research Collaboration Centre of Excellence in Public Health Northern Ireland, School of Medicine, Dentistry & Biological Sciences, Queen's University Belfast, Belfast, UK
| | - Thomas J George
- Department of Medicine, College of Medicine, University of Florida, Gainesville, FL, USA
| | - Jeffrey Pufahl
- Center for Arts in Medicine, The College of Arts, University of Florida, Gainesville, FL, USA
| | - Janice L Krieger
- Department of Advertising, College of Journalism and Communications, University of Florida, Gainesville, FL, USA
- STEM Translational Communication Center, College of Journalism and Communications, University of Florida, Gainesville, FL, USA
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Nielsen ZE, Berthelsen CB. Cancer patients' perceptions of factors influencing their decisions on participation in clinical drug trials: A qualitative meta-synthesis. J Clin Nurs 2019; 28:2443-2461. [PMID: 30673153 DOI: 10.1111/jocn.14785] [Citation(s) in RCA: 36] [Impact Index Per Article: 6.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/26/2018] [Revised: 11/28/2018] [Accepted: 01/13/2019] [Indexed: 12/19/2022]
Abstract
AIMS AND OBJECTIVES To examine cancer patients' perceptions of factors that may influence their decisions on participating in phase I-III clinical drug trials. BACKGROUND The number of cancer participants in clinical drug trials has increased rapidly in Denmark in recent years. The rights, safety and well-being of patients considering participation are protected by the international, ethical and scientific principles. A meta-synthesis was conducted to enable health professionals to support cancer patients who are considering trial participation in accordance with the above principles. DESIGN Meta-synthesis. METHODS A qualitative meta-synthesis, as described by Sandelowski and Barroso, was conducted based on a literature search in PubMed, CINAHL, EMBASE and PsycINFO. Nine reports were found eligible and were included. The PRISMA checklist was used. RESULTS A framework was developed, and patients' perceptions of the factors influencing their decisions were identified, namely patients' perceptions of their relatives, the physician, the hope of therapeutic benefit, altruism, having other options and living with cancer. CONCLUSIONS This study shows that cancer patients' decisions on participation in clinical drug trials are influenced by their perceptions of trust towards the physician, their relatives' attitudes and the consequences participation might have for their families. Patients are motivated to participate due to the hope of therapeutic benefit and for altruistic reasons. The factors influencing their decisions to participate include a cost-benefit consideration, which in turn may be subject to the patient's perception of having other options available besides participation. This may be related to the patient's attitude towards living with cancer, and the decision can be a way of trying to cope with the psychological aspects of living with cancer. RELEVANCE TO CLINICAL PRACTICE The results of this meta-synthesis offer insight into patients' perceptions of what may influence their decisions, and they enable health professionals to support patients making such decisions.
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Affiliation(s)
- Zandra Engelbak Nielsen
- Clinical Research Unit, Department of Oncology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark
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14
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Participation of elderly gynecological cancer patients in clinical trials. Arch Gynecol Obstet 2018; 298:797-804. [DOI: 10.1007/s00404-018-4886-2] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/28/2018] [Accepted: 08/24/2018] [Indexed: 01/04/2023]
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15
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Paludo J, Abeykoon JP, Shreders A, Ansell SM, Kumar S, Ailawadhi S, King RL, Koehler AB, Reeder CB, Buadi FK, Dispenzieri A, Lacy MQ, Dingli D, Witzig TE, Go RS, Gonsalves WI, Kourelis T, Warsame R, Leung N, Habermann TM, Hayman S, Lin Y, Kyle RA, Rajkumar SV, Gertz MA, Kapoor P. Bendamustine and rituximab (BR) versus dexamethasone, rituximab, and cyclophosphamide (DRC) in patients with Waldenström macroglobulinemia. Ann Hematol 2018; 97:1417-1425. [DOI: 10.1007/s00277-018-3311-z] [Citation(s) in RCA: 42] [Impact Index Per Article: 6.0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/21/2017] [Accepted: 03/19/2018] [Indexed: 12/31/2022]
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Kurt A, Kincaid H, Semler L, Jacoby JL, Johnson MB, Careyva BA, Stello B, Friel T, Smulian JC, Knouse MC. Impact of Race Versus Education and Race Versus Income on Patients' Motivation to Participate in Clinical Trials. J Racial Ethn Health Disparities 2017; 5:1042-1051. [PMID: 29280106 DOI: 10.1007/s40615-017-0452-z] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/17/2017] [Revised: 10/23/2017] [Accepted: 12/01/2017] [Indexed: 11/25/2022]
Abstract
Our study investigates whether levels of motivation and barriers to participation in clinical trials vary with patients' education and income. A self-administered survey asked outpatients to rank potential influential factors on a "0" to "4" significance scale for their motivation to participate in clinical trials. Principal component analysis (PCA), analysis of variance (ANOVA), Kruskal-Wallis, and Mann-Whitney U tests analyzed the impact of race, education, and income on their motivation to participate. Analysis included 1841 surveys; most respondents had a high school education or some college, and listed annual income < $30,000. There was a significant interaction between race and income on our motivation scale 1 scores (p = .0261). Compared with their counterparts, subjects with less education/lower income ranked monetary compensation (p = .0420 and p < .0001, respectively) as a higher motivator. Minorities and patients with less education and lower income appear to be more influenced by their desire to please the doctor, the race and sex of the doctor, and the language spoken by the doctor being the same as theirs. For all races, education appeared to have a direct relationship with motivation to participate, except for African-Americans, whose motivation appeared to decline with more education. Income appeared to have an inverse relationship with motivation to participate for all races.
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Affiliation(s)
- Anita Kurt
- Lehigh Valley Health Network, Cedar Crest Boulevard and I-78, Allentown, PA, 18103, USA.
- LVHN-Muhlenberg, Emergency Medicine Research, 4th Floor, South Wing, 2545 Schoenersville Road, Bethlehem, PA, 18107, USA.
| | - Hope Kincaid
- Lehigh Valley Health Network, Cedar Crest Boulevard and I-78, Allentown, PA, 18103, USA
| | - Lauren Semler
- Lehigh Valley Health Network, Cedar Crest Boulevard and I-78, Allentown, PA, 18103, USA
| | - Jeanne L Jacoby
- Lehigh Valley Health Network, Cedar Crest Boulevard and I-78, Allentown, PA, 18103, USA
| | - Melanie B Johnson
- Lehigh Valley Health Network, Cedar Crest Boulevard and I-78, Allentown, PA, 18103, USA
| | - Beth A Careyva
- Lehigh Valley Health Network, Cedar Crest Boulevard and I-78, Allentown, PA, 18103, USA
| | - Brian Stello
- Lehigh Valley Health Network, Cedar Crest Boulevard and I-78, Allentown, PA, 18103, USA
| | - Timothy Friel
- Lehigh Valley Health Network, Cedar Crest Boulevard and I-78, Allentown, PA, 18103, USA
| | - John C Smulian
- Lehigh Valley Health Network, Cedar Crest Boulevard and I-78, Allentown, PA, 18103, USA
| | - Mark C Knouse
- Lehigh Valley Health Network, Cedar Crest Boulevard and I-78, Allentown, PA, 18103, USA
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Renovanz M, Hechtner M, Kohlmann K, Janko M, Nadji-Ohl M, Singer S, Ringel F, Coburger J, Hickmann AK. Compliance with patient-reported outcome assessment in glioma patients: predictors for drop out. Neurooncol Pract 2017; 5:129-138. [PMID: 31385978 DOI: 10.1093/nop/npx026] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/30/2022] Open
Abstract
Background Patient-reported outcomes are of high importance in clinical neuro-oncology. However, assessment is still suboptimal. We aimed at exploring factors associated with the probability for a) drop out of study and b) death during follow-up. Methods Patients were assessed twice during follow-up visits scheduled within 3 to 5 months of each other by using 3 validated patient-reported outcome measures (t1: first assessment, t2: second assessment). As "death" was seen as a competing risk for drop out, univariate competing risk Cox regression models were applied to explore factors associated with dropping out (age, gender, WHO grade, living situation, recurrent surgery, Karnofsky Performance Status, time since diagnosis, and patient-reported outcomes assessed by Distress Thermometer, EORTC-QLQ-C30, EORTC-QLQ-BN20, and SCNS-SF-34G). Results Two hundred forty-six patients were eligible, 173 (70%) participated. Patients declining participation were diagnosed with glioblastomas more often than with other gliomas (56% vs 39%). At t2, 32 (18%) patients dropped out, n = 14 death-related, n = 18 for other reasons. Motor dysfunction (EORTC-QLQ-BN20) was associated with higher risk for non-death-related drop out (HR: 1.02; 95% CI, 1.00-1.03; P = .03). Death-related drop out was associated with age (HR: 1.09; 95% CI, 1.03-1.14; P = .002), Karnofsky Performance Status (HR: 0.92; 95% CI, 0.88-0.96; P < .001), lower physical functioning (EORTC-QLQ-C30; HR: 0.98; 95% CI, 0.96-1.00; P = .04) and lower motor functioning (EORTC-QLQ-BN20; HR: 1.020; 95% CI, 1.00-1.04; P = .02). Conclusion Patients with motor dysfunction and poorer clinical condition seem to be more likely to drop out of studies applying patient-reported outcome measures. This should be taken into account when planning studies assessing glioma patients and for interpretation of results of patient-reported outcome assessments in clinical routine.
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Affiliation(s)
- Mirjam Renovanz
- Department of Neurosurgery, University Medical Center, Johannes-Gutenberg-University Mainz, Mainz Germany
| | - Marlene Hechtner
- Division of Epidemiology and Health Services Research, Institute of Medical Biostatistics, Epidemiology and Informatics, University Medical Center, Johannes-Gutenberg-University Mainz, Mainz Germany
| | - Karoline Kohlmann
- Department of Neurosurgery, University Medical Center, Johannes-Gutenberg-University Mainz, Mainz Germany
| | - Mareile Janko
- Department of Neurosurgery, University Medical Center, Johannes-Gutenberg-University Mainz, Mainz Germany
| | - Minou Nadji-Ohl
- Department of Neurosurgery Klinikum Stuttgart, Katharinenhospital, Stuttgart Germany
| | - Susanne Singer
- Division of Epidemiology and Health Services Research, Institute of Medical Biostatistics, Epidemiology and Informatics, University Medical Center, Johannes-Gutenberg-University Mainz, Mainz Germany
| | - Florian Ringel
- Department of Neurosurgery, University Medical Center, Johannes-Gutenberg-University Mainz, Mainz Germany
| | - Jan Coburger
- Department of Neurosurgery, University Medical Center Ulm/Günzburg, Günzburg Germany
| | - Anne-Katrin Hickmann
- Department of Neurosurgery Klinikum Stuttgart, Katharinenhospital, Stuttgart Germany.,Department of Neurosurgery Hirslanden Klinikum, Luzern Switzerland
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Krieger JL, Neil JM, Strekalova YA, Sarge MA. Linguistic Strategies for Improving Informed Consent in Clinical Trials Among Low Health Literacy Patients. J Natl Cancer Inst 2017; 109:2905672. [PMID: 27794035 PMCID: PMC5441300 DOI: 10.1093/jnci/djw233] [Citation(s) in RCA: 26] [Impact Index Per Article: 3.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/31/2016] [Revised: 08/10/2016] [Accepted: 09/12/2016] [Indexed: 11/27/2022] Open
Abstract
Background Improving informed consent to participate in randomized clinical trials (RCTs) is a key challenge in cancer communication. The current study examines strategies for enhancing randomization comprehension among patients with diverse levels of health literacy and identifies cognitive and affective predictors of intentions to participate in cancer RCTs. Methods Using a post-test-only experimental design, cancer patients (n = 500) were randomly assigned to receive one of three message conditions for explaining randomization (ie, plain language condition, gambling metaphor, benign metaphor) or a control message. All statistical tests were two-sided. Results Health literacy was a statistically significant moderator of randomization comprehension (P = .03). Among participants with the lowest levels of health literacy, the benign metaphor resulted in greater comprehension of randomization as compared with plain language (P = .04) and control (P = .004) messages. Among participants with the highest levels of health literacy, the gambling metaphor resulted in greater randomization comprehension as compared with the benign metaphor (P = .04). A serial mediation model showed a statistically significant negative indirect effect of comprehension on behavioral intention through personal relevance of RCTs and anxiety associated with participation in RCTs (P < .001). Conclusions The effectiveness of metaphors for explaining randomization depends on health literacy, with a benign metaphor being particularly effective for patients at the lower end of the health literacy spectrum. The theoretical model demonstrates the cognitive and affective predictors of behavioral intention to participate in cancer RCTs and offers guidance on how future research should employ communication strategies to improve the informed consent processes.
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Affiliation(s)
- Janice L. Krieger
- Affiliations of authors: STEM Translational Communication Center (JLK, JMN, YAS), Department of Advertising (JLK), and Division of Graduate Studies and Research (YAS), College of Journalism and Communications, University of Florida; Department of Advertising, College of Media and Communication, Texas Tech University (MAS), Gainesville, FL, Lubbock, TX
| | - Jordan M. Neil
- Affiliations of authors: STEM Translational Communication Center (JLK, JMN, YAS), Department of Advertising (JLK), and Division of Graduate Studies and Research (YAS), College of Journalism and Communications, University of Florida; Department of Advertising, College of Media and Communication, Texas Tech University (MAS), Gainesville, FL, Lubbock, TX
| | - Yulia A. Strekalova
- Affiliations of authors: STEM Translational Communication Center (JLK, JMN, YAS), Department of Advertising (JLK), and Division of Graduate Studies and Research (YAS), College of Journalism and Communications, University of Florida; Department of Advertising, College of Media and Communication, Texas Tech University (MAS), Gainesville, FL, Lubbock, TX
| | - Melanie A. Sarge
- Affiliations of authors: STEM Translational Communication Center (JLK, JMN, YAS), Department of Advertising (JLK), and Division of Graduate Studies and Research (YAS), College of Journalism and Communications, University of Florida; Department of Advertising, College of Media and Communication, Texas Tech University (MAS), Gainesville, FL, Lubbock, TX
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Roick J, Danker H, Kersting A, Briest S, Dietrich A, Dietz A, Einenkel J, Papsdorf K, Lordick F, Meixensberger J, Mössner J, Niederwieser D, Prietzel T, Schiefke F, Stolzenburg JU, Wirtz H, Singer S. Factors associated with non-participation and dropout among cancer patients in a cluster-randomised controlled trial. Eur J Cancer Care (Engl) 2017; 27. [PMID: 28134477 DOI: 10.1111/ecc.12645] [Citation(s) in RCA: 18] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 12/05/2016] [Indexed: 12/01/2022]
Abstract
We investigated the impact of demographic and disease related factors on non-participation and dropout in a cluster-randomised behavioural trial in cancer patients with measurements taken between hospitalisation and 6 months thereafter. The percentages of non-participation and dropout were documented at each time point. Factors considered to be potentially related with non-participation and dropout were as follows: age, sex, marital status, education, income, employment status, tumour site and stage of disease. Of 1,338 eligible patients, 24% declined participation at baseline. Non-participation was higher in older patients (Odds Ratio [OR] 2.1, CI: 0.6-0.9) and those with advanced disease (OR 2.0, CI: 0.1-1.3). Dropout by 6 months was 25%. Dropout was more frequent with increased age (OR 2.8, CI: 0.8-1.2), advanced disease (OR 3.0, CI: 1.0-1.2), being married (OR 2.4, CI 0.7-1.1) and less frequent with university education (OR 0.4, CI -1.3 to -0.8) and middle income (OR 0.4, CI -0.9 to -0.7). When planning clinical trials, it is important to be aware of patient groups at high risk of non-participation or dropout, for example older patients or those with advanced disease. Trial designs should consider their special needs to increase their rate of participation.
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Affiliation(s)
- J Roick
- Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Leipzig, Leipzig, Germany
| | - H Danker
- Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Leipzig, Leipzig, Germany
| | - A Kersting
- Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Leipzig, Leipzig, Germany
| | - S Briest
- Department of Obstetrics and Gynecology, University Medical Center Leipzig, Leipzig, Germany
| | - A Dietrich
- Department of Visceral-, Transplantation-, Thoracic-, and Vascular Surgery, University Medical Center Leipzig, Leipzig, Germany
| | - A Dietz
- Department of Otolaryngology, University Medical Center Leipzig, Leipzig, Germany
| | - J Einenkel
- Department of Obstetrics and Gynecology, University Medical Center Leipzig, Leipzig, Germany
| | - K Papsdorf
- Department of Radiation-Oncology, University Medical Center Leipzig, Leipzig, Germany
| | - F Lordick
- University Cancer Center, University Medical Center Leipzig, Leipzig, Germany
| | - J Meixensberger
- Department of Neurosurgery, University Medical Center Leipzig, Leipzig, Germany
| | - J Mössner
- Department of Gastroenterology, University Medical Center Leipzig, Leipzig, Germany
| | - D Niederwieser
- Department of Hematology and Oncology, University Medical Center Leipzig, Leipzig, Germany
| | - T Prietzel
- Department of Orthopedics and Accident Surgery, Helios Clinic Blankenhain, Blankenhain, Germany
| | - F Schiefke
- Department of Maxillofacial Surgery, University Medical Center Leipzig, Leipzig, Germany
| | - J-U Stolzenburg
- Department of Urology, University Medical Center Leipzig, Leipzig, Germany
| | - H Wirtz
- Department of Pneumology, University Medical Center Leipzig, Leipzig, Germany
| | - S Singer
- Institute of Medical Biostatistics, Epidemiology and Informatics (IMBEI), University Medical Centre of Johannes Gutenberg University Mainz, Mainz, Germany
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Rearden J, Hanlon AL, Ulrich C, Brooks-Carthon M, Sommers M. Examining Differences in Opportunity and Eligibility for Cancer Clinical Trial Participation Based on Sociodemographic and Disease Characteristics. Oncol Nurs Forum 2016; 43:57-66. [PMID: 26679445 DOI: 10.1188/16.onf.57-66] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/17/2022]
Abstract
PURPOSE/OBJECTIVES To examine differences in opportunity and eligibility for cancer clinical trial (CCT) participation based on sociodemographic and disease characteristics.
. DESIGN A matched cross-sectional study including a prospective oral questionnaire and retrospective electronic medical record (EMR) review.
. SETTING A single hospital in a large academic National Cancer Institute-designated cancer center in Philadelphia, Pennsylvania.
. SAMPLE 44 Black or Hispanic and 44 Non-Hispanic White newly diagnosed individuals matched on cancer type and age (plus or minus five years).
. METHODS Participants answered a questionnaire to capture self-reported opportunity for CCT participation, sociodemographic information, and cancer type. With consent, the authors completed a retrospective review of the EMR to assess eligibility and collect cancer stage and performance status.
. MAIN RESEARCH VARIABLES Opportunity and eligibility for CCT participation.
. FINDINGS Most participants (78%) had no opportunity for participation and were ineligible for all available trials. No differences were noted in opportunity for participation or eligibility based on race or ethnicity. Participants with late-stage disease were more likely to have opportunity and be eligible for CCT participation (p = 0.001). Those with private insurance were less likely to have opportunity for participation (p = 0.05).
. CONCLUSIONS Limited trial availability and ineligibility negatively influenced opportunity for CCT participation for all populations. Levels of under-representation for CCT participation likely vary within and across sociodemographic and disease characteristics, as well as across healthcare settings.
. IMPLICATIONS FOR NURSING The unique roles of nurse navigators and advanced practice nurses can be leveraged to increase opportunities for CCT participation for all populations.
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Borno H, Siegel A, Ryan C. The problem of representativeness of clinical trial participants: understanding the role of hidden costs. J Health Serv Res Policy 2016; 21:145-6. [PMID: 26888478 DOI: 10.1177/1355819616630568] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/15/2022]
Affiliation(s)
- Hala Borno
- UCSF Medical Center, 505 Parnassus Ave, San Francisco, CA 94143, USA.
| | - Adam Siegel
- Hematologist/Oncologist, Aurora BayCare Medical Center
| | - Charles Ryan
- Professor of Medical Oncology, University of California at San Francisco, CA
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22
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Factors influencing inclusion in digestive cancer clinical trials: A population-based study. Dig Liver Dis 2015; 47:891-6. [PMID: 26089036 DOI: 10.1016/j.dld.2015.05.017] [Citation(s) in RCA: 11] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/13/2015] [Revised: 05/05/2015] [Accepted: 05/16/2015] [Indexed: 12/11/2022]
Abstract
BACKGROUND Inclusion in a randomized therapeutic trial represents an optimal therapeutic strategy. AIMS To determine the influence of demographic characteristics and deprivation on the enrolment of patients in digestive cancer clinical trials. METHODS Between 2004 and 2010, 4632 patients were recorded by the Burgundy Digestive Cancer Registry. According to a balancing score, the 136 patients included in a clinical trial were matched with 272 patients who met the eligibility criteria for trials. Deprivation was measured by the ecological European deprivation index. A conditional multivariate logistic regression was performed. RESULTS Patients aged over 75 years were significantly less likely to be included in clinical trials than younger patients (odds ratio 0.33; [0.13-0.87]). Patients treated in private institutions were also less likely to be enrolled than those treated in public institutions (odds ratio 0.04; [0.01-0.16]; p<0.001). A relationship between type of institution and the European deprivation index was observed (p=0.017). Deprived patients were less likely to be included in clinical trials when they were managed in private institutions (odds ratio 0.706; [0.524-0.952]; p=0.022). The European deprivation index had no impact when patients were managed in other institutions. CONCLUSION The relationship between type of institution and deprivation underlines the necessity for improving patients' chance of being recruited in digestive cancer clinical trials.
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Lathan CS. Lung cancer care: the impact of facilities and area measures. Transl Lung Cancer Res 2015; 4:385-91. [PMID: 26380179 DOI: 10.3978/j.issn.2218-6751.2015.07.23] [Citation(s) in RCA: 11] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [Key Words] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/17/2015] [Accepted: 07/30/2015] [Indexed: 11/14/2022]
Abstract
Lung cancer is the leading cause of cancer related mortality in the US, and while treatment disparities by race and class have been well described in the literature, the impact of social determinates of health, and specific characteristics of the treatment centers have been less well characterized. As the treatment of lung cancer relies more upon a precision and personalized medicine approach, where patients obtain treatment has an impact on outcomes and could be a major factor in treatment disparities. The purpose of this manuscript is to discuss the manner in which lung cancer care can be impacted by poor access to high quality treatment centers, and how the built environment can be a mitigating factor in the pursuit of treatment equity.
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Affiliation(s)
- Christopher S Lathan
- McGraw/Patterson Center for Population Sciences, Dana-Farber Cancer Institute, Boston, MA, USA
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Aristizabal P, Singer J, Cooper R, Wells KJ, Nodora J, Milburn M, Gahagan S, Schiff DE, Martinez ME. Participation in pediatric oncology research protocols: Racial/ethnic, language and age-based disparities. Pediatr Blood Cancer 2015; 62:1337-44. [PMID: 25755225 PMCID: PMC4482802 DOI: 10.1002/pbc.25472] [Citation(s) in RCA: 71] [Impact Index Per Article: 7.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/29/2014] [Accepted: 01/21/2015] [Indexed: 02/06/2023]
Abstract
BACKGROUND Survival rates in pediatric oncology have improved dramatically, in part due to high patient participation in clinical trials. Although racial/ethnic inequalities in clinical trial participation have been reported in adults, pediatric data and studies comparing participation rates by socio-demographic characteristics are scarce. The goal of this study was to assess differences in research protocol participation for childhood cancer by age, sex, race/ethnicity, parental language, cancer type, and insurance status. PROCEDURE Data on enrollment in any protocol, biospecimen, or therapeutic protocols were collected and analyzed for newly diagnosed pediatric patients with cancer from 2008-2012 at Rady Children's Hospital. RESULTS Among the 353 patients included in the analysis, 304 (86.1%) were enrolled in any protocol. Enrollment in biospecimen and therapeutic protocols was 84.2% (261/310) and 81.1% (206/254), respectively. Logistic regression analyzes revealed significant enrollment underrepresentation in any protocol for Hispanics compared to Non-Hispanic whites (81% vs. 91%; Odds Ratio [OR], 0.43; 95% Confidence Interval [CI], 0.21-0.90; P = 0.021) and among children of Spanish-speaking vs. English-speaking parents (78% vs. 89%; OR, 0.45; 95%CI, 0.23-0.87; P = 0.016). Compared to patients aged 0-4 years, significant underrepresentation was also found among patients 15-21 years old (92% vs.72%; OR, 0.21; 95% CI, 0.09-0.48; P < 0.001). Similar trends were observed when analyzing enrollment in biospecimen and therapeutic protocols separately. CONCLUSIONS There was significant underrepresentation in protocol participation for Hispanics, children of Spanish-speaking parents, and patients ages 15-21. Research is needed to understand barriers to research participation among these groups underrepresented in pediatric oncology clinical trials.
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Affiliation(s)
- Paula Aristizabal
- Department of Pediatrics, University of California San Diego, San Diego, CA,Division of Pediatric Hematology/Oncology, Rady Children’s Hospital San Diego, San Diego, CA,Moores Cancer Center, University of California San Diego, La Jolla, CA
| | - Jenelle Singer
- Department of Pediatrics, University of California San Diego, San Diego, CA
| | - Renee Cooper
- Graduate School of Public Health, San Diego State University, San Diego, CA
| | - Kristen J. Wells
- Department of Psychology, San Diego State University, San Diego, CA,Department of Family and Preventive Medicine, University of California San Diego, La Jolla, CA
| | - Jesse Nodora
- Moores Cancer Center, University of California San Diego, La Jolla, CA,Department of Family and Preventive Medicine, University of California San Diego, La Jolla, CA
| | - Mehrzad Milburn
- Department of Pediatrics, University of California San Diego, San Diego, CA
| | - Sheila Gahagan
- Department of Pediatrics, University of California San Diego, San Diego, CA,Division of Pediatric Hematology/Oncology, Rady Children’s Hospital San Diego, San Diego, CA
| | - Deborah E. Schiff
- Department of Pediatrics, University of California San Diego, San Diego, CA,Division of Pediatric Hematology/Oncology, Rady Children’s Hospital San Diego, San Diego, CA
| | - Maria Elena Martinez
- Moores Cancer Center, University of California San Diego, La Jolla, CA,Department of Family and Preventive Medicine, University of California San Diego, La Jolla, CA
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Kehl KL, Arora NK, Schrag D, Ayanian JZ, Clauser SB, Klabunde CN, Kahn KL, Fletcher RH, Keating NL. Discussions about clinical trials among patients with newly diagnosed lung and colorectal cancer. J Natl Cancer Inst 2014; 106:dju216. [PMID: 25217775 PMCID: PMC4168309 DOI: 10.1093/jnci/dju216] [Citation(s) in RCA: 35] [Impact Index Per Article: 3.2] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/07/2013] [Revised: 02/22/2014] [Accepted: 06/13/2014] [Indexed: 01/13/2023] Open
Abstract
BACKGROUND Clinical trials are essential to establish the effectiveness of new cancer therapies, but less than 5% of adults with cancer enroll in trials. In addition to ineligibility or lack of available trials, barriers to enrollment may include limited patient awareness about the option of participation. METHODS We surveyed a multiregional cohort of patients with lung or colorectal cancer (or their surrogates) three to six months after diagnosis. We assessed whether respondents reported learning that clinical trial participation might be an option, and, if so, with whom they discussed trials. We used logistic regression to assess the association of patient characteristics with discussing trial participation and enrolling in trials. All statistical tests were two-sided. RESULTS Of 7887 respondents, 1114 (14.1%) reported discussing the possibility of clinical trial participation; most learned about trials from their physicians, and 287 patients (3.6% of all patients, 25.8% of trial discussants) enrolled. Among 2173 patients who received chemotherapy for advanced (stage III/IV lung or stage IV colorectal) cancer, 25.7% discussed trials, and 7.6% (29.5% of trial discussants) enrolled. Discussions were less frequent among older patients, African American or Asian vs white patients, and those with lower incomes and more comorbidity. Enrollment was higher among patients reporting shared vs physician-driven decisions (all P < .05). CONCLUSIONS In this population-based cohort, only 14% of patients discussed participation in clinical trials. Discussions were more frequent among advanced cancer patients but were still reported by a minority of patients. Strategies to expand access to trials and facilitate patient-provider communication about participation may accelerate development of better cancer therapeutics.
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Affiliation(s)
- Kenneth L Kehl
- Division of General Internal Medicine, Brigham and Women's Hospital, Boston, MA (KLK, NLK); Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, MD (NKA, SBC, CNK); Division of Population Sciences, Dana-Farber Cancer Institute, Boston, MA (DS); Institute for Healthcare Policy and Innovation, University of Michigan, Ann Arbor, MI (JZA); University of California, Los Angeles and RAND Corporation, Santa Monica, CA (KK); Department of Population Medicine (RHF) and Department of Health Care Policy (NLK, JZA), Harvard Medical School, Boston, MA
| | - Neeraj K Arora
- Division of General Internal Medicine, Brigham and Women's Hospital, Boston, MA (KLK, NLK); Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, MD (NKA, SBC, CNK); Division of Population Sciences, Dana-Farber Cancer Institute, Boston, MA (DS); Institute for Healthcare Policy and Innovation, University of Michigan, Ann Arbor, MI (JZA); University of California, Los Angeles and RAND Corporation, Santa Monica, CA (KK); Department of Population Medicine (RHF) and Department of Health Care Policy (NLK, JZA), Harvard Medical School, Boston, MA
| | - Deborah Schrag
- Division of General Internal Medicine, Brigham and Women's Hospital, Boston, MA (KLK, NLK); Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, MD (NKA, SBC, CNK); Division of Population Sciences, Dana-Farber Cancer Institute, Boston, MA (DS); Institute for Healthcare Policy and Innovation, University of Michigan, Ann Arbor, MI (JZA); University of California, Los Angeles and RAND Corporation, Santa Monica, CA (KK); Department of Population Medicine (RHF) and Department of Health Care Policy (NLK, JZA), Harvard Medical School, Boston, MA
| | - John Z Ayanian
- Division of General Internal Medicine, Brigham and Women's Hospital, Boston, MA (KLK, NLK); Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, MD (NKA, SBC, CNK); Division of Population Sciences, Dana-Farber Cancer Institute, Boston, MA (DS); Institute for Healthcare Policy and Innovation, University of Michigan, Ann Arbor, MI (JZA); University of California, Los Angeles and RAND Corporation, Santa Monica, CA (KK); Department of Population Medicine (RHF) and Department of Health Care Policy (NLK, JZA), Harvard Medical School, Boston, MA
| | - Steven B Clauser
- Division of General Internal Medicine, Brigham and Women's Hospital, Boston, MA (KLK, NLK); Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, MD (NKA, SBC, CNK); Division of Population Sciences, Dana-Farber Cancer Institute, Boston, MA (DS); Institute for Healthcare Policy and Innovation, University of Michigan, Ann Arbor, MI (JZA); University of California, Los Angeles and RAND Corporation, Santa Monica, CA (KK); Department of Population Medicine (RHF) and Department of Health Care Policy (NLK, JZA), Harvard Medical School, Boston, MA
| | - Carrie N Klabunde
- Division of General Internal Medicine, Brigham and Women's Hospital, Boston, MA (KLK, NLK); Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, MD (NKA, SBC, CNK); Division of Population Sciences, Dana-Farber Cancer Institute, Boston, MA (DS); Institute for Healthcare Policy and Innovation, University of Michigan, Ann Arbor, MI (JZA); University of California, Los Angeles and RAND Corporation, Santa Monica, CA (KK); Department of Population Medicine (RHF) and Department of Health Care Policy (NLK, JZA), Harvard Medical School, Boston, MA
| | - Katherine L Kahn
- Division of General Internal Medicine, Brigham and Women's Hospital, Boston, MA (KLK, NLK); Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, MD (NKA, SBC, CNK); Division of Population Sciences, Dana-Farber Cancer Institute, Boston, MA (DS); Institute for Healthcare Policy and Innovation, University of Michigan, Ann Arbor, MI (JZA); University of California, Los Angeles and RAND Corporation, Santa Monica, CA (KK); Department of Population Medicine (RHF) and Department of Health Care Policy (NLK, JZA), Harvard Medical School, Boston, MA
| | - Robert H Fletcher
- Division of General Internal Medicine, Brigham and Women's Hospital, Boston, MA (KLK, NLK); Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, MD (NKA, SBC, CNK); Division of Population Sciences, Dana-Farber Cancer Institute, Boston, MA (DS); Institute for Healthcare Policy and Innovation, University of Michigan, Ann Arbor, MI (JZA); University of California, Los Angeles and RAND Corporation, Santa Monica, CA (KK); Department of Population Medicine (RHF) and Department of Health Care Policy (NLK, JZA), Harvard Medical School, Boston, MA
| | - Nancy L Keating
- Division of General Internal Medicine, Brigham and Women's Hospital, Boston, MA (KLK, NLK); Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, MD (NKA, SBC, CNK); Division of Population Sciences, Dana-Farber Cancer Institute, Boston, MA (DS); Institute for Healthcare Policy and Innovation, University of Michigan, Ann Arbor, MI (JZA); University of California, Los Angeles and RAND Corporation, Santa Monica, CA (KK); Department of Population Medicine (RHF) and Department of Health Care Policy (NLK, JZA), Harvard Medical School, Boston, MA.
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Haynes-Maslow L, Godley P, Dimartino L, White B, Odom J, Richmond A, Carpenter W. African American women's perceptions of cancer clinical trials. Cancer Med 2014; 3:1430-9. [PMID: 24905181 PMCID: PMC4302693 DOI: 10.1002/cam4.284] [Citation(s) in RCA: 32] [Impact Index Per Article: 2.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/10/2013] [Revised: 03/21/2014] [Accepted: 03/24/2014] [Indexed: 11/11/2022] Open
Abstract
Cancer clinical trials are important for resolving cancer health disparities for several reasons; however, clinical trial participation among African Americans is significantly lower than Caucasians. This study engaged focus groups of 82 female African American cancer survivors or cancer caregivers, including those in better resourced, more urban areas and less resourced, more rural areas. Informed by an integrated conceptual model, the focus groups examined perceptions of cancer clinical trials and identified leverage points that future interventions may use to improve enrollment rates. Study findings highlight variation in community knowledge regarding cancer clinical trials, and the importance of community education regarding clinical trials and overcoming historical stigma associated with clinical research specifically and the health care system more generally. Study participants commented on the centrality of churches in their communities, and thus the promise of the church as loci of such education. Findings also suggested the value of informed community leaders as community information sources, including community members who have a previous diagnosis of cancer and clinical trial experience. The sample size and location of the focus groups may limit the generalizability of the results. Since the women in the focus groups were either cancer survivors or caregivers, they may have different experiences than nonparticipants who lack the close connection with cancer. Trust in the health system and in one's physician was seen as important factors associated with patient willingness to enroll in clinical trials, and participants suggested that physicians who were compassionate and who engaged and educated their patients would build important trust requisite for patient participation in clinical trials.
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Affiliation(s)
- Lindsey Haynes-Maslow
- Health Policy and Management, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina
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