Three Birds With One Stone

University of Aarhus

Status: Completed

Conditions: Early Detection of Cancer; Colorectal Carcinoma; Uterine Cervical Cancer; Uterine Cervical Neoplasm; Colorectal Neoplasms; Uterine Cervix Cancer; Mass Screening; Colorectal Cancer

Treatments: Behavioral: Screening status

Study type: Interventional

Funder types: Other

Identifiers

NCT05022511

Three birds with one stone

Details and patient eligibility

About

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

Full 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.

Enrollment: 27,099 patients

Sex: Female

Ages: 50 to 69 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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27,099 participants in 2 patient groups

Intervention group

Experimental group

Description:

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.

Treatment:

Behavioral: Screening status

Control group

No Intervention group

Description:

Women in the control group will receive standard screening offers according to the national screening programme.