Mobile testing of the BREASTChoice decision tool (Aim 1b)
Dissemination of a Breast Reconstruction Decision Tool Through Social Media and Online Communities- AIM1-B
NA · UNC Lineberger Comprehensive Cancer Center · NCT07396766
We will test whether breast cancer patients can easily use and understand a mobile-friendly version of the BREASTChoice decision aid.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | UNC Lineberger Comprehensive Cancer Center (other) |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT07396766 on ClinicalTrials.gov |
What this trial studies
This aim enrolls 20 breast cancer patients to perform usability testing of an updated, mobile-friendly BREASTChoice decision aid using a think-aloud protocol while they use the tool on their phones. Participants complete a baseline questionnaire, are observed and interviewed with semi-structured, open-ended prompts about content, format, design elements, comprehension, ease of use, and engagement, and then complete a post survey. Knowledge is measured before and after with the Decision Quality Instrument to quantify changes. Results and qualitative feedback will be analyzed to produce concrete recommendations for the final version and broader online dissemination.
Who should consider this trial
Good fit: Adults assigned female at birth who had breast surgery for cancer, DCIS, or high risk within the past eight years and can read and speak English are the intended participants.
Not a fit: Individuals with unstable medical or psychiatric conditions that preclude participation, non-English speakers, people whose qualifying breast surgery was more than eight years ago, or those who do not use mobile devices are unlikely to benefit from this usability test.
Why it matters
Potential benefit: If successful, the mobile-friendly BREASTChoice could help more patients make reconstruction decisions that better match their values and improve decision quality.
How similar studies have performed: Earlier versions of BREASTChoice have been tested in two clinical studies and shown to improve decision quality, though this aim focuses specifically on mobile usability and broader online dissemination.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Chapel Hill, North Carolina
- The University of North Carolina — Chapel Hill, North Carolina, United States (RECRUITING)
Study contacts
- Principal investigator: Clara Lee — UNC Lineberger Comprehensive Cancer Center
- Study coordinator: Victoria Triana
- Email: Victoria_Triana@med.unc.edu
- Phone: 919-966-4320
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer, Breast Neoplasms, web-based patient decision aid, BREASTChoice