跳至主要内容
临床试验/NCT06361056
NCT06361056已完成不适用

A User-centered Mobile Health App to Promote Participation of Black Women in Breast Cancer Clinical Trials - Clinical Trial mHealth Study

UNC Lineberger Comprehensive Cancer Center1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年5月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
Feasibility of Mobile Health Application (mHealth app)- subjects

研究概览

简要总结

This study explores the overall feasibility, impact, and satisfaction of using the "mHealth app" on clinic workflow for Black or African American women diagnosed with breast cancer.

The "mHealth app" which can be used as a platform to share clinical trial education and communication, was created and tested in previous steps of this study.

详细描述

A patient advisory council (PAC) was recruited from established hospital and community networks (North Carolina Cancer Hospital's Patient and Family Advisory Board, and the Lineberger Community Outreach and Engagement Office's Community Advisory Board). The PAC informed the content of interview guides, questionnaire/survey instruments, and mHealth app design, and will be involved in the analyses of qualitative and quantitative data, and dissemination of study results.

After analysis of the in-depth interviews, the Connected Health for Applications and Interventions (CHAI) core staff developed a progressive web application "mHealth app". mHealth app was tested in a pilot study included 20 African American (AA) patients diagnosed with breast cancer were interviewed to answer questions that will better inform the clinical trial education and communication needs of Black women with breast cancer.

Eighty African American women with newly diagnosed breast cancer who have access to a mobile device or computer will be recruited for the study intervention. Women will receive access to the "mHealth" app, a list of available clinical trials within a 50-mile radius of their zip code, and the existing standard of care packet of cancer center resources. Participants will complete a brief questionnaire that will assess clinical trial knowledge, how often a clinical trial discussion occurred during their oncology appointment, and if a therapeutic trial was offered.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

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

入选标准

  • 18 years or older
  • English speaking
  • Able and willing to participate to complete the survey.
  • Have access to a mobile device or computer.
  • Diagnosed with breast cancer.
  • Identify as African American

排除标准

  • Inability to read and speak English.
  • Dementia altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.

研究组 & 干预措施

mHealth app

Experimental

Women enrolled in the mHealth app study will receive access to the "mHealth" app, a list of available clinical trials within a 50-mile radius of their zip code, and the existing standard of care packet of cancer center resources.

干预措施: Survey (Behavioral)

mHealth app

Experimental

Women enrolled in the mHealth app study will receive access to the "mHealth" app, a list of available clinical trials within a 50-mile radius of their zip code, and the existing standard of care packet of cancer center resources.

干预措施: mHealth app (Behavioral)

结局指标

主要结局

Feasibility of Mobile Health Application (mHealth app)- subjects

时间窗: Up to 1 year

The feasibility of the mHealth app will be determined by the percentage of subjects who enrolled and completed trial requirements.

Feasibility of Mobile Health Application (mHealth app) - Clinicians and staff

时间窗: Up to 1 year

Clinicians and staff will be interviewed to assess feasibility.

次要结局

  • Overall satisfaction(Up to 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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