Three Birds With One Stone

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05022511
• Other study ID #: Three birds with one stone
• Status: Completed
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: September 1, 2023

Study information

• Verified date: September 2022
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Carcinoma
• Colorectal Neoplasms
• Early Detection of Cancer
• Mass Screening
• Neoplasms
• Uterine Cervical Cancer
• Uterine Cervical Neoplasm
• Uterine Cervical Neoplasms
• Uterine Cervix Cancer

Intervention

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.

Locations

Country	Name	City	State
Denmark	Anne Dorte Lerche Helgestad	Randers

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

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