| NCT ID | NCT07396766 |
| Status | Recruiting |
| Phase | — |
| Sponsor | UNC Lineberger Comprehensive Cancer Center |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-10-01 |
| Primary Completion | 2026-09-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-10-01 with a primary completion date of 2026-09-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Contact & Investigator
Clara Lee
PRINCIPAL INVESTIGATOR
UNC Lineberger Comprehensive Cancer Center
Frequently Asked Questions
Who can join the NCT07396766 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07396766 currently recruiting?
Yes, NCT07396766 is actively recruiting participants. Contact the research team at Victoria_Triana@med.unc.edu for enrollment information.
Where is the NCT07396766 trial being conducted?
This trial is being conducted at Chapel Hill, United States.
Who is sponsoring the NCT07396766 clinical trial?
NCT07396766 is sponsored by UNC Lineberger Comprehensive Cancer Center. The principal investigator is Clara Lee at UNC Lineberger Comprehensive Cancer Center. The trial plans to enroll 20 participants.
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