Breast Cancer Screening in Ghana

The Pennsylvania State University (PENNSTATE)

Status: Active, not recruiting

Conditions: Breast Cancer Female

Treatments: Other: Bundling; Other: MEGH

Study type: Interventional

Funder types: Other

Identifiers

NCT06362993

STUDY00021561

Details and patient eligibility

About

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.

Enrollment: 118 patients

Sex: Female

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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118 participants in 3 patient groups

Control

No Intervention group

Description:

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.

Bundling

Experimental group

Description:

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.

Treatment:

Other: Bundling

Male Engagement in Gender and Health (MEGH)

Experimental group

Description:

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.

Treatment:

Other: MEGH