Dissemination of BREASTChoice AIM1-B

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID
NCT07396766
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Baseline Questionnaire — BEHAVIORAL
    Participants will be screened and share demographic information during screening. If eligible and screened in, the interviewer will send the self-administered pre-survey Decision Quality Index (DQI).
  • Semi structured Interview — BEHAVIORAL
    Participants will participate in a semi-structured interview and review of the adapted BREASTChoice tool.
  • Post Survey — BEHAVIORAL
    Participants will take the post-survey to assess breast reconstruction decision quality.

Study Details

This registration covers only Aim 1b, which focuses on testing usability. The study will include 20 participants who are breast cancer patients. Participants will be observed using the tool on their mobile devices, and their experience will be evaluated using a "think-aloud" method to capture their thoughts and reactions. Interviews will include open-ended questions about the content and format of the decision aid, with follow-up prompts to gather feedback on design elements (length, order, graphics), comprehension, ease of use, acceptance, and engagement with the tool. Knowledge will be measured using the Decision Quality Instrument before and after using the tool. Results will be analyzed to develop recommendations for the final version of the tool.

Key Dates

Start date
Oct 1, 2025
Status verified
Jan 2026
Primary completion
Jan 20, 2029
Completion
Jan 20, 2029

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Breast cancer survivors
    Breast cancer survivors.

Primary Outcome Measure

Change in breast reconstruction knowledge [ Time Frame: Up to1 week ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of North CarolinaChapel HillNorth Carolina27599
Kathryn A Chetwynd
[email protected]
919-966-4320
Clara Lee, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chapel Hill, NC

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
The University of North Carolina· Chapel Hill, NC

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