Mobile Health App to Promote Participation of Black Women in Breast Cancer Clinical Trials

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06361056
• Other study ID #: LCCC2140
• Status: Recruiting
• Phase: N/A
• Start date: May 2, 2022
• Est. completion date: January 2026

Study information

• Verified date: April 2024
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: Lauren Matthews
• Phone: 919-843-5321
• Email: lauren_matthews[@]med.unc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: January 2026
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• Survey
All participants will complete a brief questionnaire.
• mHealth app
Eighty Black women with newly diagnosed breast cancer (inclusive of all stages) and who have access to a mobile device or computer will be recruited to the study intervention.

Locations

Country	Name	City	State
United States	UNC Lineberger Comprehensive Cancer Center	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of Mobile Health Application (mHealth app)- subjects	The feasibility of the mHealth app will be determined by the percentage of subjects who enrolled and completed trial requirements.	Up to 1 year
Primary	Feasibility of Mobile Health Application (mHealth app) - Clinicians and staff	Clinicians and staff will be interviewed to assess feasibility.	Up to 1 year
Secondary	Overall satisfaction	Overall satisfaction will be assessed by survey questions administered to study participants. The rate of participants' satisfactions will be reported.	Up to 1 year

External Links

•   University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials