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Completed

NCT Number: NCT06361056

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27514, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

survey

Behavioral

All participants will complete a brief questionnaire.

Other names: Questionnaire

mHealth app

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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

  1. 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.

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Collaborators

  • Conquer Cancer Foundation

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Apr 11, 2024
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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