Three birds with one stone: a protocol for a randomised intervention study to increase participation in cervical and colorectal cancer screening among women attending breast cancer screening

Anne Dorte Lerche Helgestad, Mette Bach Larsen, Sisse Njor, Mette Tranberg, Lone Kjeld Petersen, Berit Andersen, Anne Dorte Lerche Helgestad, Mette Bach Larsen, Sisse Njor, Mette Tranberg, Lone Kjeld Petersen, Berit Andersen

Abstract

Introduction: The participation rate is higher in breast cancer screening than in cervical cancer (CCU) and colorectal cancer (CRC) screening. In this cluster-randomised study, we aim to evaluate an intervention offering home-based CCU and CRC screening to women when attending breast cancer screening if they are overdue for CCU and/or CRC screening.

Methods and analysis: On intervention days, one of the five breast cancer screening units in the Central Denmark Region will be randomly allocated to intervention, whereas the remaining units will serve as control. Women attending breast cancer screening in the intervention unit will be offered information regarding their CCU and CRC screening history, and, if overdue, they will be offered self-sampling screening kits. For CCU screening, women aged 50-64 years will be offered a vaginal self-sampling kit for human papillomavirus testing. For CRC screening, women aged 50-69 years will be offered a kit to obtain a faecal immunochemical test. Women attending the control units will receive only standard care.After the intervention, a survey will be sent to all women in the intervention and control group, asking about their experience while attending breast cancer screening.Primary outcomes will be difference in the coverage in CCU and CRC screening 6 months after intervention between the intervention and the control group, and difference in participation rates 6 months after intervention for those who were overdue for CCU and/or CRC screening at the time of the intervention.

Ethics and dissemination: The project is listed in the record of processing activities for research projects in the Central Denmark Region (R. No.: 1-16-02-217-21). According to the Danish Consolidation Act on Research Ethics Review of Health Research Project, this study was not notifiable to the Committee (R. No.: 1-10-72-1-21). The findings will be disseminated in peer-reviewed scientific journals.

Trial registration number: NCT05022511.

Keywords: HEALTH SERVICES ADMINISTRATION & MANAGEMENT; ONCOLOGY; PREVENTIVE MEDICINE; PRIMARY CARE; PUBLIC HEALTH.

Conflict of interest statement

Competing interests: Roche Diagnostics sponsors the Cobas 4800 HPV DNA tests. According to the contract between Roche Diagnostics and the University Research Clinic for Cancer screening, the Department of Public Health Programmes, Randers Regional Hospital, Roche Diagnostics has no influence on the scientific process and no editorial rights pertaining to this manuscript. MT, LKP and BA have participated in other studies with human papillomavirus (HPV) DNA tests sponsored by Roche Diagnostics. MT has received honoraria from Roche Diagnostics for lectures on HPV self-sampling. SN has received a speaking fee from Norgine and LKP has received speakers fee from AstraZeneca and MSD.

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Consolidated Standards of Reporting Trials 2010 flow diagram of the study for primary outcomes. CCU, cervical cancer; CDR, Central Denmark Region; CRC, colorectal cancer.
Figure 2
Figure 2
Flow diagram of the intervention. CCU, cervical cancer; CRC, colorectal cancer; FIT, faecal immunochemical test; HPV, human papillomavirus.

References

    1. Cancer Screening in the European Union . Report on the implementation of the Council recommendation on cancer screening International Agency for Research on Cancer, screening group; 2017.
    1. Basu P, Ponti A, Anttila A, et al. . Status of implementation and organization of cancer screening in the European Union member States-Summary results from the second European screening report. Int J Cancer 2018;142:44–56. 10.1002/ijc.31043
    1. Senore C, Basu P, Anttila A, et al. . Performance of colorectal cancer screening in the European Union member states: data from the second European screening report. Gut 2019;68:1232–44. 10.1136/gutjnl-2018-317293
    1. Deandrea S, Molina-Barceló A, Uluturk A, et al. . Presence, characteristics and equity of access to breast cancer screening programmes in 27 European countries in 2010 and 2014. Results from an international survey. Prev Med 2016;91:250–63. 10.1016/j.ypmed.2016.08.021
    1. Gianino MM, Lenzi J, Bonaudo M, et al. . Organized screening programmes for breast and cervical cancer in 17 EU countries: trajectories of attendance rates. BMC Public Health 2018;18:1236. 10.1186/s12889-018-6155-5
    1. Camilloni L, Ferroni E, Cendales BJ, et al. . Methods to increase participation in organised screening programs: a systematic review. BMC Public Health 2013;13:464. 10.1186/1471-2458-13-464
    1. Duffy SW, Myles JP, Maroni R, et al. . Rapid review of evaluation of interventions to improve participation in cancer screening services. J Med Screen 2017;24:127–45. 10.1177/0969141316664757
    1. Tranberg M, Bech BH, Blaakær J, et al. . Preventing cervical cancer using HPV self-sampling: direct mailing of test-kits increases screening participation more than timely opt-in procedures - a randomized controlled trial. BMC Cancer 2018;18:273. 10.1186/s12885-018-4165-4
    1. Vejborg I, Njor SH, Andersen VD. Dansk kvalitetsdatabase for mammografiscreening: Årsrapport 2019. [Danish quality database for mammography screening, 2019. Annual report. Available:
    1. Waldstrøm M, Andersen ABT, Viborg PH. Dansk Kvalitetsdatabase for Livmoderhalskræft. Årsrapport 2019 [Danish Quality Database for Cervical Cancer Screening, 2019. Annual report. Available:
    1. Rasmussen M, Ragner AZK, Njor SH. Dansk Tarmkræftscreeningsdatase. Årsrapport 2019 [Danish Quality Database for Colorectal Cancer. Annual report 2019], 2021. Available:
    1. Scott SE, Rauf B, Waller J. "Whilst you are here…" Acceptability of providing advice about screening and early detection of other cancers as part of the breast cancer screening programme. Health Expect 2021;24:1868–78. 10.1111/hex.13330
    1. Mikkelsen EM, Njor SH, Vejborg I. Danish quality database for mammography screening. Clin Epidemiol 2016;8:661–6. 10.2147/CLEP.S99467
    1. Schmidt M, Schmidt SAJ, Adelborg K, et al. . The Danish health care system and epidemiological research: from health care contacts to database records. Clin Epidemiol 2019;11:563–91. 10.2147/CLEP.S179083
    1. The Danish Agency for Digitalisation . Statistik om Digital post [in Danish]. Available: [Accessed Dec 2021].
    1. Chan A-W, Tetzlaff JM, Gøtzsche PC, et al. . Spirit 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ 2013;346:e7586. 10.1136/bmj.e7586
    1. van Baars R, Bosgraaf RP, ter Harmsel BWA, et al. . Dry storage and transport of a cervicovaginal self-sample by use of the Evalyn brush, providing reliable human papillomavirus detection combined with comfort for women. J Clin Microbiol 2012;50:3937–43. 10.1128/JCM.01506-12
    1. Tranberg M, Jensen JS, Bech BH, et al. . Good concordance of HPV detection between cervico-vaginal self-samples and general practitioner-collected samples using the COBAS 4800 HPV DNA test. BMC Infect Dis 2018;18:348. 10.1186/s12879-018-3254-y
    1. Rao A, Young S, Erlich H, et al. . Development and characterization of the COBAS human papillomavirus test. J Clin Microbiol 2013;51:1478–84. 10.1128/JCM.03386-12
    1. Solomon D, Davey D, Kurman R, et al. . The 2001 Bethesda system: terminology for reporting results of cervical cytology. JAMA 2002;287:2114–9. 10.1001/jama.287.16.2114
    1. Flowchart 23-64 år, selvopsamlede prøver [in Danish]. Available: [Accessed 09 Jun 2021].
    1. Njor SH, Friis-Hansen L, Andersen B, et al. . Three years of colorectal cancer screening in Denmark. Cancer Epidemiol 2018;57:39–44. 10.1016/j.canep.2018.09.003
    1. Hemming K, Eldridge S, Forbes G, et al. . How to design efficient cluster randomised trials. BMJ 2017;358:j3064. 10.1136/bmj.j3064
    1. Bjerregaard B, Larsen OB. The Danish pathology register. Scand J Public Health 2011;39:72–4. 10.1177/1403494810393563
    1. Rygaard C. The Danish quality database for cervical cancer screening. Clin Epidemiol 2016;8:655–60. 10.2147/CLEP.S99509
    1. Thomsen MK, Njor SH, Rasmussen M, et al. . Validity of data in the Danish colorectal cancer screening database. Clin Epidemiol 2017;9:105–11. 10.2147/CLEP.S124454
    1. Gjerstorff ML. The Danish cancer registry. Scand J Public Health 2011;39:42–5. 10.1177/1403494810393562
    1. Schmidt M, Schmidt SAJ, Sandegaard JL, et al. . The Danish national patient registry: a review of content, data quality, and research potential. Clin Epidemiol 2015;7:449–90. 10.2147/CLEP.S91125
    1. Hammer A, Kahlert J, Gravitt PE, et al. . Hysterectomy-corrected cervical cancer mortality rates in Denmark during 2002-2015: a registry-based cohort study. Acta Obstet Gynecol Scand 2019;98:1063–9. 10.1111/aogs.13608
    1. The division of research services. [Available in English]. Available: [Accessed Apr 2021].
    1. Harris PA, Taylor R, Thielke R, et al. . Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform 2009;42:377–81. 10.1016/j.jbi.2008.08.010

Source: PubMed

Sponsors et collaborateurs

Les conditions médicales

Interventions en matière de drogue

3
S'abonner