NCT06361056

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started May 2022

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 2, 2022

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

March 22, 2024

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 11, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 26, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2025

Completed
Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

3.2 years

First QC Date

March 22, 2024

Last Update Submit

February 9, 2026

Conditions

Keywords

applicationmHealth

Outcome Measures

Primary Outcomes (2)

  • 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

  • Feasibility of Mobile Health Application (mHealth app) - Clinicians and staff

    Clinicians and staff will be interviewed to assess feasibility.

    Up to 1 year

Secondary Outcomes (1)

  • Overall satisfaction

    Up to 1 year

Study Arms (1)

mHealth app

EXPERIMENTAL

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: SurveyBehavioral: mHealth app

Interventions

SurveyBEHAVIORAL

All participants will complete a brief questionnaire.

Also known as: Questionnaire
mHealth app
mHealth appBEHAVIORAL

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.

mHealth app

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsParticipants are women with breast cancer
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Inability to read and speak English.
  • Dementia altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27514, United States

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Marjory Charlot, MD, MPH, MSc

    UNC Lineberger Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2024

First Posted

April 11, 2024

Study Start

May 2, 2022

Primary Completion

July 26, 2025

Study Completion

November 20, 2025

Last Updated

February 12, 2026

Record last verified: 2026-02

Locations