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

February 9, 2026 updated by: UNC Lineberger Comprehensive Cancer Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • UNC Lineberger Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: Survey
All participants will complete a brief questionnaire.
Other Names:
  • Questionnaire
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 1 year
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.
Up to 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall satisfaction
Time Frame: Up to 1 year
Overall satisfaction will be assessed by survey questions administered to study participants. The rate of participants' satisfactions will be reported.
Up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UNC Lineberger Comprehensive Cancer Center

Collaborators

Conquer Cancer Foundation

Investigators

  • Principal Investigator: Marjory Charlot, MD, MPH, MSc, UNC Lineberger Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2022

Primary Completion (Actual)

July 26, 2025

Study Completion (Actual)

November 20, 2025

Study Registration Dates

First Submitted

March 22, 2024

First Submitted That Met QC Criteria

April 8, 2024

First Posted (Actual)

April 11, 2024

Study Record Updates

Last Update Posted (Actual)

February 12, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LCCC2140

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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