Colorectal Cancer, Colorectal Carcinoma, Colorectal Neoplasms, Early Detection of Cancer, Mass Screening, Uterine Cervical Cancer, Uterine Cervical Neoplasm, Uterine Cervix Cancer
Conditions
Brief 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.
Interventions
BEHAVIORALScreening 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.
Sponsors
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 69 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Coverage | 180 days after participating in breast cancer screening | Difference in overall coverage og CCU/CRC screening six months after the intervention between control and intervention group |
| Participation | 180 days after participating in breast cancer screening | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | After test completion, expected to be 1 year | 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 |
| Rate of compliance to follow-up with colonoscopy after a positive FIT | Within 60 days from a positive FIT | — |
| 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 | Within 180 days after a positive hrHPV self-sample | A GP collected sample after a hrHPV positive self-sample |
| Register-based screening history of self-samplers in CCU screening | After test completion. expected to be 1 year | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Proportion of women not returning a test kit | At end of enrollment | Process outcome within the intervention group |
| Previous screening history, previous cancer diagnoses, socioeconomic data (age, ethnicity, marital status, educational status) and inflammatory bowel disease | At end of enrollment | To test if the randomisation succeeded |
| Survey evaluation | At end of enrollment | Evaluation regarding the acceptability of the intervention |
| Proportion of women accepting a check up on CCU and CRC screening status | At end of enrollment | Process outcome within the intervention group |
| Proportion of women accepting a test-kit | At end of enrollment | Process outcome within the intervention group |
| Proportion of women overdue with CCU and/or CRC screening | At end of enrollment | Process outcome within the intervention group |
Countries
Denmark
Outcome results
None listed