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. 2022 Sep 22;12(9):e062824. doi: 10.1136/bmjopen-2022-062824

Table 2.

All items from the WHO Trial Registration Data Set

Data category Information
Primary registry and trial identifying number ClinicalTrials.gov, NCT05022511
Date of registration in primary registry 10 August 2021
Secondary identifying numbers N/A
Source(s) of monetary or material support University Research Clinic for Cancer Screening and the Department of Public Health Programmes, Randers Regional Hospital, Denmark
Primary sponsor University Research Clinic for Cancer Screening and the Department of Public Health Programmes, Randers Regional Hospital, Denmark
Secondary sponsor(s) Department of Clinical Medicine, Aarhus University, Denmark
Contact for public queries Anne Dorte Lerche Helgestad, MD (annesper@rm.dk)
Contact for scientific queries Anne Dorte Lerche Helgestad, MD
University Research Clinic for Cancer Screening and the Department of Public Health Programmes, Randers Regional Hospital, Denmark
Public title Three birds with one stone
Scientific 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
Countries of recruitment Denmark
Health condition(s) or problem(s) studied Cervical cancer and colorectal cancer screening
Intervention(s) Active comparator: An offer to receive information on screening status in cervical and colorectal cancer screening when attending breast cancer screening. If overdue for one or both screening programmes, self-sampling screening test(s) is/are offered.
Control comparator: Standard screening offers according to the national screening programmes.
Key inclusion and exclusion criteria Ages eligible for study: 50–64 years (cervical cancer screening), 50–69 years (colorectal cancer screening)
Sexes eligible for study: Women
Accepts healthy volunteers: No
Inclusion criteria: Women aged 50–69 years booked for a breast cancer screening on an intervention day
Exclusion criteria: Not eligible for cervical or colorectal cancer screening, did not attend breast cancer screening, changed appointment for breast cancer screening after randomisation, insufficient Danish skills to provide informed consent
Study type Interventional
Allocation: Cluster randomised intervention model. Parallel assignment 1:4.
Primary purpose: Prevention
Date of first enrolment September 2021
Target sample size 37 000
Recruitment status Recruiting
Primary outcome(s)
  1. Difference between intervention and control group with respect to coverage in cervical cancer/colorectal cancer screening 6 months after the intervention.

  2. Difference between the intervention and the control group in proportion of women participating in cervical cancer and colorectal screening after 6 months for women who were overdue for their cervical cancer/colorectal cancer screening at the intervention.

Key secondary outcomes For both cervical and colorectal cancer screening, secondary outcomes will be screening-related outcome, clinical follow-up, satisfaction with breast cancer screening during intervention and process outcomes.