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Trial Title:
Mobile Health App to Promote Participation of Black Women in Breast Cancer Clinical Trials
NCT ID:
NCT06361056
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
application
mHealth
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Health Services Research
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Survey
Description:
All participants will complete a brief questionnaire.
Arm group label:
mHealth app
Other name:
Questionnaire
Intervention type:
Behavioral
Intervention name:
mHealth app
Description:
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.
Arm group label:
mHealth app
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.
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Gender based:
Yes
Gender description:
Participants are women with breast cancer
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
UNC Lineberger Comprehensive Cancer Center
Address:
City:
Chapel Hill
Zip:
27514
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lauren Matthews
Phone:
919-843-5321
Email:
lauren_matthews@med.unc.edu
Investigator:
Last name:
Marjory Charlot, MD, MPH, MSc
Email:
Principal Investigator
Start date:
May 2, 2022
Completion date:
January 2026
Lead sponsor:
Agency:
UNC Lineberger Comprehensive Cancer Center
Agency class:
Other
Source:
UNC Lineberger Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06361056
http://unclineberger.org/patientcare/clinical-trials/clinical-trials
