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Three Birds With One Stone

Primary Purpose

Uterine Cervical Cancer, Uterine Cervix Cancer, Uterine Cervical Neoplasm

Status
Active
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Screening status
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Uterine Cervical Cancer

Eligibility Criteria

50 Years - 69 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Anne Dorte Lerche Helgestad

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm 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.

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

Outcomes

Primary Outcome Measures

Coverage
Difference in overall coverage og CCU/CRC screening six months after the intervention between control and intervention group
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

Secondary Outcome Measures

Prevalence of hrHPV in self-samples in CCU screening
Rate of compliance to follow-up in CCU screening
A GP collected sample after a hrHPV positive 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.
Prevalence of colposcopies after CCU screening
Incidence of CIN2+
Incidence of hrHPV positive cases in women 60-64 years after 12 months with an initial negative hrHPV sample in CCU screening
Prevalence of positive FIT cases after CRC screening for those overdue at the intervention date
Histology (number of adenomas, cancer) after a positive FIT in CRC screening
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
Rate of compliance to follow-up with colonoscopy after a positive FIT

Full Information

First Posted
August 10, 2021
Last Updated
May 12, 2023
Sponsor
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT05022511
Brief Title
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

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
December 1, 2022 (Actual)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Cervical Cancer, Uterine Cervix Cancer, Uterine Cervical Neoplasm, Colorectal Neoplasms, Colorectal Cancer, Colorectal Carcinoma, Mass Screening, Early Detection of Cancer

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27099 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm 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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Women in the control group will receive standard screening offers according to the national screening programme.
Intervention Type
Behavioral
Intervention Name(s)
Screening status
Intervention Description
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.
Primary Outcome Measure Information:
Title
Coverage
Description
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
Title
Participation
Description
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 Outcome Measure Information:
Title
Prevalence of hrHPV in self-samples in CCU screening
Time Frame
After study completion, expected to be 1 year
Title
Rate of compliance to follow-up in CCU screening
Description
A GP collected sample after a hrHPV positive self-sample
Time Frame
Within 180 days after a positive hrHPV self-sample
Title
Register-based screening history of self-samplers in CCU screening
Description
"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
Title
Prevalence of colposcopies after CCU screening
Time Frame
Within 180 days after a positive hrHPV self-sample
Title
Incidence of CIN2+
Time Frame
Within 180 days after a positive hrHPV self-sample
Title
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
Title
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
Title
Histology (number of adenomas, cancer) after a positive FIT in CRC screening
Time Frame
After test completion, expected to be 1 year
Title
Register-based screening history in CRC screening
Description
"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
Title
Rate of compliance to follow-up with colonoscopy after a positive FIT
Time Frame
Within 60 days from a positive FIT
Other Pre-specified Outcome Measures:
Title
Proportion of women accepting a check up on CCU and CRC screening status
Description
Process outcome within the intervention group
Time Frame
At end of enrollment
Title
Proportion of women overdue with CCU and/or CRC screening
Description
Process outcome within the intervention group
Time Frame
At end of enrollment
Title
Proportion of women accepting a test-kit
Description
Process outcome within the intervention group
Time Frame
At end of enrollment
Title
Proportion of women not returning a test kit
Description
Process outcome within the intervention group
Time Frame
At end of enrollment
Title
Previous screening history, previous cancer diagnoses, socioeconomic data (age, ethnicity, marital status, educational status) and inflammatory bowel disease
Description
To test if the randomisation succeeded
Time Frame
At end of enrollment
Title
Survey evaluation
Description
Evaluation regarding the acceptability of the intervention
Time Frame
At end of enrollment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Berit Andersen, Prof., MD, Head of Department
Organizational Affiliation
Department of Public Health Programmes and University Clinic for Cancer Screening, Randers Regional Hospital and Department of Clinical Medicine, Aarhus University
Official's Role
Study Chair
Facility Information:
Facility Name
Anne Dorte Lerche Helgestad
City
Randers
ZIP/Postal Code
8930
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
36137619
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.
Results Reference
derived

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Three Birds With One Stone

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