Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06361056
Enrollment
80
Registered
2024-04-11
Start date
2022-05-02
Completion date
2025-11-20
Last updated
2026-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

application, mHealth

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.

Interventions

BEHAVIORALSurvey

All participants will complete a brief questionnaire.

BEHAVIORALmHealth 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.

Sponsors

UNC Lineberger Comprehensive Cancer Center
Lead SponsorOTHER
Conquer Cancer Foundation
CollaboratorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of Mobile Health Application (mHealth app)- subjectsUp to 1 yearThe 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 staffUp to 1 yearClinicians and staff will be interviewed to assess feasibility.

Secondary

MeasureTime frameDescription
Overall satisfactionUp to 1 yearOverall satisfaction will be assessed by survey questions administered to study participants. The rate of participants' satisfactions will be reported.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORMarjory Charlot, MD, MPH, MSc

UNC Lineberger Comprehensive Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026