Three Birds With One Stone

NCT05022511CompletedNAINTERVENTIONAL

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

Key Facts

Lead Sponsor

University of Aarhus

Enrollment

27099

Start Date

2021-09-01

Completion Date

2022-12-01

Study Type

INTERVENTIONAL

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

Interventions

Screening status

Conditions

Uterine Cervical CancerUterine Cervix CancerUterine Cervical NeoplasmColorectal NeoplasmsColorectal CancerColorectal CarcinomaMass ScreeningEarly Detection of Cancer

Eligibility

Age Range

50 Years – 69 Years

Sex

FEMALE

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.

Outcome Measures

Primary Outcomes

Coverage

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

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

Time frame: 180 days after participating in breast cancer screening

Secondary Outcomes

Prevalence of hrHPV in self-samples in CCU screening

Time frame: 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

Time frame: 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.

Time frame: After test completion. expected to be 1 year

Prevalence of colposcopies after CCU screening

Time frame: Within 180 days after a positive hrHPV self-sample

Incidence of CIN2+

Time frame: 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

Time frame: After test completion, expected to be 1 year

Prevalence of positive FIT cases after CRC screening for those overdue at the intervention date

Time frame: After test completion, expected to be 1 year

Histology (number of adenomas, cancer) after a positive FIT in CRC screening

Time frame: 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

Time frame: After test completion, expected to be 1 year

Rate of compliance to follow-up with colonoscopy after a positive FIT

Time frame: Within 60 days from a positive FIT

Locations

Anne Dorte Lerche Helgestad, Randers, Denmark

Three Birds With One Stone