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Trial Title:
Breast Cancer Screening in Ghana
NCT ID:
NCT06362993
Condition:
Breast Cancer Female
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Health Services Research
Masking:
Double (Participant, Care Provider)
Intervention:
Intervention type:
Other
Intervention name:
Bundling
Description:
Education on and screening for diabetes and hypertension offered together with education
and screening for breast cancer.
Arm group label:
Bundling
Intervention type:
Other
Intervention name:
MEGH
Description:
Education on breast cancer and discussion sessions to male partners to change men's
gender attitudes and behaviors.
Arm group label:
Male Engagement in Gender and Health (MEGH)
Summary:
This study is designed to test the feasibility of two intervention on promoting early
screening for breast cancer in rural Ghana. In one intervention, screening for breast
cancer, diabetes and hypertension will be offered together. In another intervention, a
series of sessions with men will be conducted with a goal to change gender attitudes and
increase support to women. The investigators' long-term goal is to test these
interventions in a large-scale randomized controlled trial. The specific aims of this
feasibility study are to: 1) refine the study materials, including the curriculum for the
sessions with men, by consulting with an expert advisory committee and a local committee,
and 2) determine the feasibility of the two interventions in four clinic zones in
Yilo-Krobo district in eastern Ghana (1 clinic in control, 1 clinic in the first
intervention, and 2 in the second intervention). This trial registration is for the
second specific aim.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- ≥20 years. The age cutoff reflects early onset of BC in Ghana and the government's
guidelines on screening.
Exclusion Criteria:
- ever clinically diagnosed with a case of breast cancer, as the study's aim is to
reach women who would normally not visit or have experience with the health system
with regard to breast cancer.
NOTE: For men in the MEGH arm, Inclusion and Exclusion Criteria are:
Inclusion Criteria: aged ≥20 years who are identified as male partners or relatives by
the women enrolled in the MEGH group.
Exclusion Criteria: none.
Gender:
Female
Minimum age:
20 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Start date:
June 2024
Completion date:
March 2025
Lead sponsor:
Agency:
Penn State University
Agency class:
Other
Collaborator:
Agency:
University of Ghana
Agency class:
Other
Source:
Penn State University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06362993
