Three Birds With One Stone

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Behavioral: Screening status


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women aged 50-69 years attending breast cancer screening in Central Denmark Region on selected days. In CCU screening: women aged 50-64 years will be classified as overdue if they have not had a cervical sample within the last 5 years and 6 months In CRC screening: women aged 50-69 years will be classified as overdue, if they have not had a FIT within the last 2 years and 4.5 months despite an invitation.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>All women aged 50-69 years attending breast cancer screening in the intervention unit on an intervention day. They will all be offered to receive information on their screening status in cervical cancer og colorectal cancer screening. Women aged 50-64 years, who have not had a cervical cytology sample taken within 5 years and 6 months will be offered to receive a self-sample device for high risk human papilloma virus (hrHPV) screening by mail, or reminded to see her general practitioner (GP) to have a conventional cervical cytology sample taken. Women aged 50-69 years, who have not had a Faecal Immunochemical Test (FIT) within 2 years and 4.5 months will be offered to receive a new self-sampling kit for FIT. | Behavioral: Screening status<br>* 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.<br>|
| No Intervention: Control group<br>Women in the control group will receive standard screening offers according to the national screening programme. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coverage | Difference in overall coverage og CCU/CRC screening six months after the intervention between control and intervention group | 180 days after participating in breast cancer screening | 
| Participation | Difference between intervention and control group in proportion of women participating in CCU and CRC screening after 180 days for those overdue with CCU/CRC screening at the intervention | 180 days after participating in breast cancer screening | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of hrHPV in self-samples in CCU screening |  | After study completion, expected to be 1 year | 
| Rate of compliance to follow-up in CCU screening | A GP collected sample after a hrHPV positive self-sample | Within 180 days after a positive hrHPV self-sample | 
| Register-based screening history of self-samplers in CCU screening | Under-screened defined as screened at least once with in the last 10 years prior to the intervention. Un-screened defined as no screening sample with in the last 10 years prior to the intervention. | After test completion. expected to be 1 year | 
| Prevalence of colposcopies after CCU screening |  | Within 180 days after a positive hrHPV self-sample | 
| Incidence of CIN2+ |  | Within 180 days after a positive hrHPV self-sample | 
| Incidence of hrHPV positive cases in women 60-64 years after 12 months with an initial negative hrHPV sample in CCU screening |  | After test completion, expected to be 1 year | 
| Prevalence of positive FIT cases after CRC screening for those overdue at the intervention date |  | After test completion, expected to be 1 year | 
| Histology (number of adenomas, cancer) after a positive FIT in CRC screening |  | After test completion, expected to be 1 year | 
| Register-based screening history in CRC screening | Under-screened defined as at least one FIT, but none with the last 2 years and 4.5 months. Un-screened defined as no previous FIT despite invitation | After test completion, expected to be 1 year | 
| Rate of compliance to follow-up with colonoscopy after a positive FIT |  | Within 60 days from a positive FIT |