Colorectal Cancer Clinical Trial
Official title:
Three Birds With One Stone: a Randomised Intervention Study to Increase Participation in Cervical and Colorectal Cancer Screening Among Women Attending Breast Cancer Screening
Verified date | September 2022 |
Source | University of Aarhus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 27099 |
Est. completion date | September 1, 2023 |
Est. primary completion date | December 1, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 50 Years to 69 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Denmark | Anne Dorte Lerche Helgestad | Randers |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Proportion of women accepting a check up on CCU and CRC screening status | Process outcome within the intervention group | At end of enrollment | |
Other | Proportion of women overdue with CCU and/or CRC screening | Process outcome within the intervention group | At end of enrollment | |
Other | Proportion of women accepting a test-kit | Process outcome within the intervention group | At end of enrollment | |
Other | Proportion of women not returning a test kit | Process outcome within the intervention group | At end of enrollment | |
Other | Previous screening history, previous cancer diagnoses, socioeconomic data (age, ethnicity, marital status, educational status) and inflammatory bowel disease | To test if the randomisation succeeded | At end of enrollment | |
Other | Survey evaluation | Evaluation regarding the acceptability of the intervention | At end of enrollment | |
Primary | 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 | |
Primary | 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 | Prevalence of hrHPV in self-samples in CCU screening | After study completion, expected to be 1 year | ||
Secondary | 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 | |
Secondary | 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 | |
Secondary | Prevalence of colposcopies after CCU screening | Within 180 days after a positive hrHPV self-sample | ||
Secondary | Incidence of CIN2+ | Within 180 days after a positive hrHPV self-sample | ||
Secondary | 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 | ||
Secondary | Prevalence of positive FIT cases after CRC screening for those overdue at the intervention date | After test completion, expected to be 1 year | ||
Secondary | Histology (number of adenomas, cancer) after a positive FIT in CRC screening | After test completion, expected to be 1 year | ||
Secondary | 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 | |
Secondary | Rate of compliance to follow-up with colonoscopy after a positive FIT | Within 60 days from a positive FIT |
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