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临床试验/NCT06362993
NCT06362993进行中(未招募)不适用

Testing Approaches to Promote Breast Cancer Screening in Rural Ghana

Penn State University1 个研究点 分布在 1 个国家目标入组 118 人开始时间: 2024年8月18日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
118
试验地点
1
主要终点
Clinical breast exam (CBE) utilization at the local clinic

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

Clinical breast exam (CBE) utilization at the local clinic

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yubraj Acharya, Ph.D.

Associate Professor

Penn State University

研究点 (1)

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