Clinical Trials Directory

Trials / Recruiting

RecruitingNCT07396766

Dissemination of BREASTChoice AIM1-B

Dissemination of a Breast Reconstruction Decision Tool Through Social Media and Online Communities- AIM1-B

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
20 (estimated)
Sponsor
UNC Lineberger Comprehensive Cancer Center · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed description

This study is part of a larger project that will update and adapt an existing online decision tool called BREASTChoice. The project includes interviews and user testing with breast cancer survivors, interviews with medical experts, and updates to the website design. Breast reconstruction after a mastectomy is an important part of breast cancer treatment. It can help restore quality of life and body image, which are often affected after surgery. However, many patients, especially those who identify as Black or Hispanic/Latina are not always offered reconstruction. Some patients also lack information about the risks and benefits, leading to choices that may not match their personal preferences. The BREASTChoice decision aid was created to help patients make informed choices about breast reconstruction. It has been tested in two clinical studies and shown to improve decision quality. Patients and doctors found it helpful and easy to use, but many asked for a version that works better on mobile devices and can be shared with family and friends. So far, BREASTChoice has mostly been used in clinics and has not reached many people outside of them. To reach more patients, the tool will be adapted for use on social media and online communities, places where many people already go for health information and support. In the U.S., most adults use social media (about 81%) and search the internet for health information (about 72%). Even most older adults (60%) go online. Breast cancer survivors are especially active in online groups. Early findings show that survivors would use BREASTChoice if it were available through social media. Following the Designing for Dissemination approach, and in partnership with three cancer survivor organizations and two clinician groups, this project will adapt BREASTChoice and share it through social media and online communities.

Conditions

Interventions

TypeNameDescription
BEHAVIORALBaseline QuestionnaireParticipants 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).
BEHAVIORALSemi structured InterviewParticipants will participate in a semi-structured interview and review of the adapted BREASTChoice tool.
BEHAVIORALPost SurveyParticipants will take the post-survey to assess breast reconstruction decision quality.

Timeline

Start date
2025-10-01
Primary completion
2029-01-20
Completion
2029-01-20
First posted
2026-02-09
Last updated
2026-02-09

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT07396766. Inclusion in this directory is not an endorsement.