Three Birds With One Stone

NCT05022511 | Completed

• 1 other identifier: Three birds with one stone
• Study Type: interventional
• Target: 27,099
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• 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

  Within 180 days after a positive hrHPV self-sample

• Register-based screening history of self-samplers in CCU screening

  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

Other Outcomes (6)

• Proportion of women accepting a check up on CCU and CRC screening status

  At end of enrollment

• Proportion of women overdue with CCU and/or CRC screening

  At end of enrollment

• Proportion of women accepting a test-kit

  At end of enrollment

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

Screening status BEHAVIORAL

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.

Intervention group

Eligibility Criteria

• Age: 50 Years - 69 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Anne Dorte Lerche Helgestad

Randers, 8930, Denmark

Location

Related Publications (2)

• Helgestad ADL, Larsen MB, Njor S, Tranberg M, Petersen LK, Andersen B. Increasing coverage in cervical and colorectal cancer screening by leveraging attendance at breast cancer screening: A cluster-randomised, crossover trial. PLoS Med. 2024 Aug 13;21(8):e1004431. doi: 10.1371/journal.pmed.1004431. eCollection 2024 Aug.

  PMID: 39137185 DERIVED

• 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.

  PMID: 36137619 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2021
• First Posted: August 26, 2021
• Study Start: September 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: September 1, 2023
• Last Updated: November 18, 2023

Record last verified: 2022-09

Locations

DK (1)