- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06362993
Breast Cancer Screening in Ghana
November 30, 2025 updated by: Yubraj Acharya, Ph.D., Penn State University
Testing Approaches to Promote Breast Cancer Screening in Rural Ghana
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
118
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Accra, Ghana
- University of Ghana
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
Women in this arm receive education on breast cancer and are offered clinical breast exam free of charge at their local clinic for 6 months following the education session.
|
|
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Experimental: Bundling
Women in this arm receive education on breast cancer, diabetes, and hypertension, and are offered clinical breast exam and screening for diabetes and hypertension free of charge at their local clinic for 6 months following the education session.
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Education on and screening for diabetes and hypertension offered together with education and screening for breast cancer.
|
|
Experimental: Male Engagement in Gender and Health (MEGH)
Women in this arm receive education on breast cancer and are offered clinical breast exam free of charge at their local clinic for 6 months following the education session.
In addition, women are requested to invite their male partners to attend the breast cancer education session and 7 weekly discussion group sessions (5 men-only and 2 with women).
The discussion sessions aim to enable men to change gender attitudes and behaviors that deter women's healthcare utilization.
|
Education on breast cancer and discussion sessions to male partners to change men's gender attitudes and behaviors.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical breast exam (CBE) utilization at the local clinic
Time Frame: 6 months. Outcome is measured at endline survey at the end of the 6-month period.
|
The outcome will be measured by asking participants, at endline, if they sought clinical breast exam at their local clinic during the 6-month study period.
This information will be verified at the clinic level using Participation Cards, which will be provided to participants at the beginning of the 6-month period.
Participants will be asked to bring the Card to the clinic when they come for screening.
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6 months. Outcome is measured at endline survey at the end of the 6-month period.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Nancy Luke, Ph.D., The Pennsylvania State University
- Study Chair: Adriana Biney, Ph.D., University of Ghana, Regional Institute for Population Studies
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 18, 2024
Primary Completion (Actual)
March 15, 2025
Study Completion (Estimated)
March 1, 2026
Study Registration Dates
First Submitted
April 9, 2024
First Submitted That Met QC Criteria
April 9, 2024
First Posted (Actual)
April 12, 2024
Study Record Updates
Last Update Posted (Actual)
December 2, 2025
Last Update Submitted That Met QC Criteria
November 30, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00021561
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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