Three Birds With One Stone

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

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

Study Overview

• Status: Completed
• Conditions: Colorectal Neoplasms; Colorectal Cancer; Colorectal Carcinoma; Uterine Cervical Cancer; Uterine Cervical Neoplasm; Mass Screening; Early Detection of Cancer; Uterine Cervix Cancer
• Intervention / Treatment: Behavioral: Screening status

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.

• Study Type: Interventional
• Enrollment (Actual): 27099
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Randers, Denmark, 8930
    • Anne Dorte Lerche Helgestad

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Women in the control group will receive standard screening offers according to the national screening programme.
Experimental: Intervention group; 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; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of women accepting a check up on CCU and CRC screening status	Process outcome within the intervention group	At end of enrollment
Proportion of women overdue with CCU and/or CRC screening	Process outcome within the intervention group	At end of enrollment
Proportion of women accepting a test-kit	Process outcome within the intervention group	At end of enrollment
Proportion of women not returning a test kit	Process outcome within the intervention group	At end of enrollment
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
Survey evaluation	Evaluation regarding the acceptability of the intervention	At end of enrollment

Collaborators and Investigators

• Sponsor: University of Aarhus
• Investigators: Study Chair: Berit Andersen, Prof., MD, Head of Department, Department of Public Health Programmes and University Clinic for Cancer Screening, Randers Regional Hospital and Department of Clinical Medicine, Aarhus University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): September 1, 2023

Study Registration Dates

• First Submitted: August 10, 2021
• First Submitted That Met QC Criteria: August 19, 2021
• First Posted (Actual): August 26, 2021

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Neoplasms; Uterine Cervical Neoplasms; Colorectal Neoplasms
• Other Study ID Numbers: Three birds with one stone

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No