Randomized Clinical Trial
Copyright ©The Author(s) 2016. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Nov 21, 2016; 22(43): 9631-9641
Published online Nov 21, 2016. doi: 10.3748/wjg.v22.i43.9631
Psychological effects of colorectal cancer screening: Participants vs individuals not invited
Benedicte Kirkøen, Paula Berstad, Edoardo Botteri, Linn Bernklev, Badboni El-Safadi, Geir Hoff, Thomas de Lange, Tomm Bernklev
Benedicte Kirkøen, Paula Berstad, Edoardo Botteri, Geir Hoff, Thomas de Lange, Department of Bowel Cancer Screening, Cancer Registry of Norway, Majorstuen, 0304 Oslo, Norway
Benedicte Kirkøen, Tomm Bernklev, Institute of Clinical Medicine, University of Oslo, Blindern, 0318 Oslo, Norway
Linn Bernklev, Thomas de Lange, Department of Internal Medicine, Vestre Viken Hospital Trust, Bærum Hospital, 3004 Drammen, Norway
Badboni El-Safadi, Department of Gastroenterology, Østfold Hospital Trust, 1714 Grålum, Norway
Geir Hoff, Tomm Bernklev, Department of Research and Development, Telemark Hospital Trust, 3710 Skien, Norway
Geir Hoff, Department of Health Management and Health Economics, Institute of Health and Society, University of Oslo, Blindern, 0317 Oslo, Norway
Author contributions: Berstad P, Hoff G and Bernklev T designed the study; Kirkøen B, Berstad P, Bernklev L and El-Safadi B collected the data; Kirkøen B analyzed the data under supervision of Botteri E (Biostatistician); Kirkøen B wrote the paper under the supervision of Berstad P, de Lange T and Bernklev T; all authors have read and revised the manuscript; Kirkøen B, Berstad P, de Lange T and Bernklev T bear the primary responsibility for the content.
Supported by the Ministry of Health and Care Services in Norway.
Institutional review board statement: The study was approved by the Regional Research Ethics Committee of South-East Norway and the Norwegian Data Inspectorate (approval no. 2011/1272). ClinicalTrials.gov: NCT01538550.
Clinical trial registration statement: This study is registered at ClinicalTrials.gov. The registration identification number is NCT01538550.
Informed consent statement: The participants gave their consent to participate in the psychological study by completing and returning the mailed questionnaire.
Conflict-of-interest statement: All authors declare that they have no conflict of interest.
Data sharing statement: Statistical code and dataset available from the corresponding author at benedicte.kirkoen@kreftregisteret.no. No additional data are available.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Benedicte Kirkøen, MSc, Department of Bowel Cancer Screening, Cancer Registry of Norway, P.O. box 5313, Majorstuen, 0304 Oslo, Norway. benedicte.kirkoen@kreftregisteret.no
Telephone: +47-45474009
Received: August 18, 2016
Peer-review started: August 21, 2016
First decision: September 5, 2016
Revised: September 19, 2016
Accepted: October 10, 2016
Article in press: October 10, 2016
Published online: November 21, 2016
Processing time: 92 Days and 12.6 Hours
Abstract
AIM

To investigate the possible long-term psychological harm of participating in colorectal cancer (CRC) screening in Norway.

METHODS

In a prospective, randomized trial, 14294 participants (aged 50-74 years) were invited to either flexible sigmoidoscopy (FS) screening, or a faecal immunochemical test (FIT) (1:1). In total, 4422 screening participants (32%) completed the questionnaire, which consisted of the Hospital Anxiety and Depression Scale and the SF-12, a generic health-related quality of life (HRQOL) measurement, when invited to screening and one year after the invitation. A control group of 7650 individuals was invited to complete the questionnaire only, at baseline and one year after, and 1911 (25%) completed the questionnaires.

RESULTS

Receiving a positive or negative screening result and participating in the two different screening modalities did not cause clinically relevant mean changes in anxiety, depression or HRQOL after one year. FS screening, but not FIT, was associated with an increased probability of being an anxiety case (score ≥ 8) at the one-year follow-up (5.6% of FS participants transitioned from being not anxious to anxious, while 3.0% experienced the reverse). This increase was moderately significantly different from the changes in the control group (in which the corresponding numbers were 4.8% and 4.5%, respectively), P = 0.06.

CONCLUSION

Most individuals do not experience psychological effects of CRC screening participation after one year, while FS participation is associated with increased anxiety for a smaller group.

Keywords: Colorectal cancer screening; Flexible sigmoidoscopy; Fecal immunochemical test; Anxiety; Health-related quality of life; Control group

Core tip: Participation in cancer screening programmes might cause worries in the population outweighing the benefits of screening. However, the results from studies of psychological harm of colorectal cancer (CRC) screening remain inconsistent. This is the first randomized study to investigate long-term changes in anxiety from before CRC screening, and compare these changes to individuals not invited to screening. Based on sound methodology, our study show that most individuals have no psychological effect of receiving a positive screening result, or participating in CRC screening after one year. However, flexible sigmoidoscopy participation is associated with increased anxiety for a smaller, possibly anxious group.