Dissemination of BREASTChoice AIM1-B
NCT07396766 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2026-02-09
Summary
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.
Conditions
- Breast Cancer
- Breast Neoplasms
Interventions
- BEHAVIORAL
-
Baseline Questionnaire
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).
- BEHAVIORAL
-
Semi structured Interview
Participants will participate in a semi-structured interview and review of the adapted BREASTChoice tool.
- BEHAVIORAL
-
Post Survey
Participants will take the post-survey to assess breast reconstruction decision quality.
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
UNC Lineberger Comprehensive Cancer Center
lead OTHER
Principal Investigators
-
Clara Lee · UNC Lineberger Comprehensive Cancer Center
Study Design
- Allocation
- NA
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-10-01
- Primary Completion
- 2029-01-20
- Completion
- 2029-01-20
Countries
- United States
Study Locations
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