Breast Cancer Screening in Ghana

NCT06362993 | Active Not Recruiting

• 1 other identifier: STUDY00021561
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Female

Outcome Measures

Primary Outcomes (1)

• Clinical breast exam (CBE) utilization at the local clinic

  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.

  6 months. Outcome is measured at endline survey at the end of the 6-month period.

Study Arms (3)

Control

NO INTERVENTION

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

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.

Other: Bundling

Male Engagement in Gender and Health (MEGH)

EXPERIMENTAL

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.

Other: MEGH

Interventions

Bundling OTHER

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

Bundling

MEGH OTHER

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

Male Engagement in Gender and Health (MEGH)

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥20 years. The age cutoff reflects early onset of BC in Ghana and the government's guidelines on screening.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Penn State University: lead
• University of Ghana: collaborator

Study Sites (1)

University of Ghana

Accra, Ghana

Location

Study Officials

• Nancy Luke, Ph.D.

  The Pennsylvania State University

  STUDY CHAIR

• Adriana Biney, Ph.D.

  University of Ghana, Regional Institute for Population Studies

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 12, 2024
• Study Start: August 18, 2024
• Primary Completion: March 15, 2025
• Study Completion: March 1, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-11

Locations

GH (1)