NCT05022511

Three Birds With One Stone

Three Birds With One Stone: a Randomised Intervention Study to Increase Participation in Cervical and Colorectal Cancer Screening Among Women Attending Breast Cancer Screening

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 27,099 (actual)
• Sponsor: University of Aarhus · Academic / Other
• Sex: Female
• Age: 50 Years – 69 Years
• Healthy volunteers: Not accepted

Summary

The overall aim of the study is to increase participation rates in cervical cancer (CCU) and colorectal cancer (CRC) screening programmes in Denmark by offering home-based CCU and CRC screening to women who are overdue for one or both screening programmes when attending breast cancer screening

Detailed description

A cluster-randomised public health trial will take place in Central Denmark Region (CDR) targeting women attending breast cancer screening. Five breast cancer screening units serve women five days a week, and all five units will be included in the study and randomly allocated to an equal amount of intervention days. On the intervention days, the other four units will serve as the control group, providing a randomisation ratio of 1:4. On the intervention days, a research assistant will ask the women aged 50-69 years if they are interested in having a check up on their screening status with CCU and CRC screening. If the woman has not participated timely, she will be offered to receive a test-kit corresponding to CRC screening and/or to receive a self-sample device for CCU screening (or reminded to call her general practitioner (GP) to have a conventional cervical cytology sample taken). If the woman accepts a self-sample kit for CCU and/or CRC screening, she will receive it by mail together with written instructions, picturebased user instructions, information on national recommendation for cancer screening and a pre-paid, pre-addressed envelope for returning the sample to the laboratory. The result of the test will be sent to the women by digital mail as well as passed on to her GP. Clinical management in case of a positive test result will follow national guidelines corresponding to CCU and CRC screening programmes. Women in the control group will receive standard screening offers according to the national screening programmes. All women entering a breast cancer screening unit in CDR on a intervention day (intervention + control units) will be sent a survey asking their experience with breast cancer screening a few days after breast cancer screening. The women in the intervention group will be asked about the acceptability of the intervention as well. 27500 women must be included, of which 5500 women will be in the intervention group.

Conditions

• Uterine Cervical Cancer
• Uterine Cervix Cancer
• Uterine Cervical Neoplasm
• Colorectal Neoplasms
• Colorectal Cancer
• Colorectal Carcinoma
• Mass Screening
• Early Detection of Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Screening status	Women are offered check-up on screening status in both CCU and CRC screening. If a woman is not up to date in one or both screening programmes, she will be offered a self-sampling device and/or a FIT kit.

Timeline

• Start date: 2021-09-01
• Primary completion: 2022-12-01
• Completion: 2023-09-01
• First posted: 2021-08-26
• Last updated: 2023-11-18

Locations

1 site across 1 country: Denmark