Clinical trial NCT05022511: Three Birds With One Stone
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uterine Cervical Cancer
Uterine Cervix Cancer
Uterine Cervical Neoplasm
Colorectal Neoplasms
Colorectal Cancer
Colorectal Carcinoma
Mass Screening
Early Detection of Cancer
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2021-08-26
Enrollment: 27099
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Coverage
timeFrame: 180 days after participating in breast cancer screening
measure: Participation
timeFrame: 180 days after participating in breast cancer screening
Secondary outcomes:
measure: Prevalence of hrHPV in self-samples in CCU screening
timeFrame: After study completion, expected to be 1 year
measure: Rate of compliance to follow-up in CCU screening
timeFrame: Within 180 days after a positive hrHPV self-sample
measure: Register-based screening history of self-samplers in CCU screening
timeFrame: After test completion. expected to be 1 year
measure: Prevalence of colposcopies after CCU screening
timeFrame: Within 180 days after a positive hrHPV self-sample
measure: Incidence of CIN2+
timeFrame: Within 180 days after a positive hrHPV self-sample
measure: Incidence of hrHPV positive cases in women 60-64 years after 12 months with an initial negative hrHPV sample in CCU screening
timeFrame: After test completion, expected to be 1 year
measure: Prevalence of positive FIT cases after CRC screening for those overdue at the intervention date
timeFrame: After test completion, expected to be 1 year
measure: Histology (number of adenomas, cancer) after a positive FIT in CRC screening
timeFrame: After test completion, expected to be 1 year
measure: Register-based screening history in CRC screening
timeFrame: After test completion, expected to be 1 year
measure: Rate of compliance to follow-up with colonoscopy after a positive FIT
timeFrame: Within 60 days from a positive FIT
Other outcomes:
measure: Proportion of women accepting a check up on CCU and CRC screening status
timeFrame: At end of enrollment
measure: Proportion of women overdue with CCU and/or CRC screening
timeFrame: At end of enrollment
measure: Proportion of women accepting a test-kit
timeFrame: At end of enrollment
measure: Proportion of women not returning a test kit
timeFrame: At end of enrollment
measure: Previous screening history, previous cancer diagnoses, socioeconomic data (age, ethnicity, marital status, educational status) and inflammatory bowel disease
timeFrame: At end of enrollment
measure: Survey evaluation
timeFrame: At end of enrollment
Locations:
city: Randers
country: Denmark
facility: Anne Dorte Lerche Helgestad
Study officials:
affiliation: Department of Public Health Programmes and University Clinic for Cancer Screening, Randers Regional Hospital and Department of Clinical Medicine, Aarhus University
name: Berit Andersen, Prof., MD, Head of Department
role: STUDY_CHAIR
References:
citation: Helgestad ADL, Larsen MB, Njor S, Tranberg M, Petersen LK, Andersen B. Three birds with one stone: a protocol for a randomised intervention study to increase participation in cervical and colorectal cancer screening among women attending breast cancer screening. BMJ Open. 2022 Sep 22;12(9):e062824. doi: 10.1136/bmjopen-2022-062824.