NCT07396766

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
32mo left

Started Oct 2025

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress19%
Oct 2025Jan 2029

Study Start

First participant enrolled

October 1, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 9, 2026

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2029

Last Updated

February 9, 2026

Status Verified

January 1, 2026

Enrollment Period

3.3 years

First QC Date

February 2, 2026

Last Update Submit

February 2, 2026

Conditions

Breast CancerBreast Neoplasms

Keywords

web-based patient decision aidBREASTChoice

Outcome Measures

Primary Outcomes (1)

  • Change in breast reconstruction knowledge

    This is knowledge based patient-reported outcome measure uses the Breast Cancer Reconstruction Decision Quality Instrument (DQI). DQ is a 9-item patient-reported measure designed to assess how well patients are informed about breast reconstruction options following breast cancer treatment. The instrument consists of multiple-choice questions with factual, correct answers related to breast reconstruction. Decision quality is quantified as a knowledge score, reflecting the extent to which patients understand key information necessary to make informed reconstruction decisions. Scores range from 0% to 100%. The total score is calculated by summing the number of correctly answered items and dividing by the total number of questions (9), with higher scores indicating greater knowledge and higher decision quality.

    Up to1 week

Study Arms (1)

Breast cancer survivors

EXPERIMENTAL

Breast cancer survivors.

Behavioral: Baseline QuestionnaireBehavioral: Semi structured InterviewBehavioral: Post Survey

Interventions

Post SurveyBEHAVIORAL

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

Breast cancer survivors
Baseline QuestionnaireBEHAVIORAL

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).

Breast cancer survivors
Semi structured InterviewBEHAVIORAL

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

Breast cancer survivors

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Individuals with self-reported or observed unstable medical or psychiatric conditions precluding informed consent or participation in the study will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of North Carolina

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Clara Lee

    UNC Lineberger Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Victoria Triana

CONTACT

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

Kathryn A Chetwynd

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2026

First Posted

February 9, 2026

Study Start

October 1, 2025

Primary Completion (Estimated)

January 20, 2029

Study Completion (Estimated)

January 20, 2029

Last Updated

February 9, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)