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Clinical Trials/NCT06362993
NCT06362993
Active, not recruiting
Not Applicable

Testing Approaches to Promote Breast Cancer Screening in Rural Ghana

Penn State University1 site in 1 country118 target enrollmentAugust 18, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer Female
Sponsor
Penn State University
Enrollment
118
Locations
1
Primary Endpoint
Clinical breast exam (CBE) utilization at the local clinic
Status
Active, not recruiting
Last Updated
5 months ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
August 18, 2024
End Date
March 1, 2026
Last Updated
5 months ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yubraj Acharya, Ph.D.

Associate Professor

Penn State University

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.

Outcomes

Primary Outcomes

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.

Study Sites (1)

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