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) |
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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. |