A User-centered Mobile Health App to Promote Participation of Black Women in Breast Cancer Clinical Trials - Clinical Trial mHealth Study
Overview
- Phase
- Not Applicable
- Intervention
- Survey
- Conditions
- Breast Cancer
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Feasibility of Mobile Health Application (mHealth app)- subjects
- Status
- Completed
- Last Updated
- 2 months ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •Inability to read and speak English.
- •Dementia altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
Arms & Interventions
mHealth app
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.
Intervention: Survey
mHealth app
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.
Intervention: mHealth app
Outcomes
Primary Outcomes
Feasibility of Mobile Health Application (mHealth app)- subjects
Time Frame: 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
Time Frame: Up to 1 year
Clinicians and staff will be interviewed to assess feasibility.
Secondary Outcomes
- Overall satisfaction(Up to 1 year)