Anne Dorte Lerche Helgestad
Randers, 8930, Denmark
NCT Number: NCT05022511
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
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Notify Me50 year–69 year
Female
Interventional
Not applicable
Randers, 8930, Denmark
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Women aged 50-69 years attending breast cancer screening in Central Denmark Region on selected days.
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.
Time frame: 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
Time frame: 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
Time frame: After study completion, expected to be 1 year
Time frame: Within 180 days after a positive hrHPV self-sample
A GP collected sample after a hrHPV positive self-sample
Time frame: 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.
Time frame: Within 180 days after a positive hrHPV self-sample
Time frame: Within 180 days after a positive hrHPV self-sample
Time frame: After test completion, expected to be 1 year
Time frame: After test completion, expected to be 1 year
Time frame: After test completion, expected to be 1 year
Time frame: 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
Time frame: Within 60 days from a positive FIT
Time frame: At end of enrollment
Process outcome within the intervention group
Time frame: At end of enrollment
Process outcome within the intervention group
Time frame: At end of enrollment
Process outcome within the intervention group
Time frame: At end of enrollment
Process outcome within the intervention group
Time frame: At end of enrollment
To test if the randomisation succeeded
Time frame: At end of enrollment
Evaluation regarding the acceptability of the intervention
University of Aarhus
Other
Three Birds With One Stone: a Randomised Intervention Study to Increase Participation in Cervical and Colorectal Cancer Screening Among Women Attending Breast Cancer Screening
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