Breast Cancer Screening in Ghana

Breast Cancer Female Clinical Trial

Official title:

Testing Approaches to Promote Breast Cancer Screening in Rural Ghana

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06362993
• Other study ID #: STUDY00021561
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: March 2025

Study information

• Verified date: June 2024
• Source: Penn State University
• Contact: Yubraj Acharya, Ph.D.
• Phone: 8148656898
• Email: yua36[@]psu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: March 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms

Intervention

Other:
• Bundling
Education on and screening for diabetes and hypertension offered together with education and screening for breast cancer.
• MEGH
Education on breast cancer and discussion sessions to male partners to change men's gender attitudes and behaviors.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Penn State University	University of Ghana

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.