Recruiting

Dissemination of BREASTChoice AIM1-B

ClinicalTrials.gov IDNCT07396766

PhaseNA

Enrollment20

SponsorUNC Lineberger Comprehensive Cancer Center

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Breast Cancer, Breast Neoplasms

About this study

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.

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.

Primary outcomes

Change in breast reconstruction knowledge (Up to1 week)

Eligibility information

Inclusions Criteria To participate in this study, a subject must meet all the eligibility criteria outlined below. * Age ≥ 18 years at the time of consent * Able to read and speak English. * Have had surgery, such as a mastectomy or lumpectomy, to remove some or all of their breast or breasts. * Breast surgery occurred within the past 8 years. * Breast surgery was due to a diagnosis of breast cancer, ductal carcinoma in situ, or risk of future breast cancer, by participant report. * Sex was assigned "Female" at birth Exclusion Criteria • Individuals with self-reported or observed unstable medical or psychiatric conditions precluding informed consent or participation in the study will be excluded.

Study locations

The University of North Carolina, Chapel Hill, North Carolina 27599 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.