Recruiting

Usability Testing

Sponsor:

UNC Lineberger Comprehensive Cancer Center

Code:

NCT07396766

Conditions

Breast Cancer

Breast Neoplasms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Baseline Questionnaire

Semi structured Interview

Post Survey

Study Details

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.

Conditions

Breast Cancer

Breast Neoplasms

Study ID

NCT07396766

Start date

Oct 1, 2025

Status verified date

Sep, 2026

Completion date

Sep 15, 2026

Anticipated

Primary completion date

Sep 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Breast cancer survivors

Breast cancer survivors.

Interventions

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).

Semi structured Interview

Participants will participate in a semi-structured interview and review of the adapted BREASTChoice tool.

Post Survey

Participants will take the post-survey to assess breast reconstruction decision quality.

Primary outcome measure

  • Change in breast reconstruction knowledge [ Time Frame: Up to1 week ]

Central Contacts and Locations

Central contacts

Victoria Triana

919-966-4320Victoria_Triana@med.unc.edu

Kathryn A Chetwynd

919-966-4320Kathryn_Chetwynd@med.unc.edu

Locations

The University of North Carolina

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Kathryn A Chetwynd

919-966-4320Kathryn_Chetwynd@med.unc.edu

Principal Investigator:

Clara Lee, MD

More Information

Sponsor

UNC Lineberger Comprehensive Cancer Center

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Keywords

  • web-based patient decision aid
  • BREASTChoice

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center on 2026-09-03.