Breast Cancer Screening in Ghana

NCT ID: NCT06362993

Last Updated: 2025-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-18

Study Completion Date

2026-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer Female

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Bundling

Intervention Type OTHER

Education on and screening for diabetes and hypertension offered together with education and screening for breast cancer.

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.

Group Type EXPERIMENTAL

MEGH

Intervention Type OTHER

Education on breast cancer and discussion sessions to male partners to change men's gender attitudes and behaviors.

Interventions

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Bundling

Education on and screening for diabetes and hypertension offered together with education and screening for breast cancer.

Intervention Type OTHER

MEGH

Education on breast cancer and discussion sessions to male partners to change men's gender attitudes and behaviors.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Ghana

OTHER

Sponsor Role collaborator

Penn State University

OTHER

Sponsor Role lead

Responsible Party

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Yubraj Acharya, Ph.D.

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nancy Luke, Ph.D.

Role: STUDY_CHAIR

The Pennsylvania State University

Adriana Biney, Ph.D.

Role: STUDY_CHAIR

University of Ghana, Regional Institute for Population Studies

Locations

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University of Ghana

Accra, , Ghana

Site Status

Countries

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Ghana

Other Identifiers

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STUDY00021561

Identifier Type: -

Identifier Source: org_study_id

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