Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06361056
Status:
RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-03-22
Brief Title:
Mobile Health App to Promote Participation of Black Women in Breast Cancer Clinical Trials
Sponsor:
UNC Lineberger Comprehensive Cancer Center
Organization:
UNC Lineberger Comprehensive Cancer Center
Study Overview
Official Title:
A User-centered Mobile Health App to Promote Participation of Black Women in Breast Cancer Clinical Trials - Clinical Trial mHealth Study
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Hospitals Patient and Family Advisory Board and the Lineberger Community Outreach and Engagement Offices Community Advisory Board The PAC informed the content of interview guides questionnairesurvey 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None