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NCT06813053NARecruiting

A Novel Patient Decision Aid for Surgical Treatment Options in Early-Stage Breast Cancer

University of Colorado, Denver

Start Date

7/21/2025

Completion Date

3/1/2027

Summary

This is a study to assess the feasibility and acceptability of a novel decision aid (DA) in a newly diagnosed, early-stage breast cancer population. Insights gained from patient feedback and the implementation process will be used to improve the information delivered in the decision aid itself and to plan for a larger scale trial to compare the decision aid to standard of care.

Detailed Description

This pilot study will utilize several tools and instruments to measure various aspects of of the implementation of the decision aid. 1. BREAST-Q patient-Reported Outcomes, 2. Ottawa Decision Aid Evaluation Measures, 3. Health Literacy Assessments, 4. Distress Screening Tools, 5. Web-Based Surveys, 6. Semi-Structured Interviews.

Eligibility Criteria

Age Range: 18 years to 100 years

Inclusion Criteria: * Adult women age 18-100 * English speaking * Clinical stage 0-III breast cancer * Eligible for both lumpectomy and mastectomy Exclusion Criteria: * Prior surgical consultation regarding treatment options for breast cancer * Previous history of breast cancer * Requires neoadjuvant chemotherapy prior to surgical intervention

Interventions

OTHER

Decision Aid (DA)

OTHER

Standard of Care (SOC)

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Conditions

Breast Cancer

Locations

Universtiy of Colorado Hospital

Aurora, Colorado 80045

United States

UCHealth Cherry Creek Medical Center

Denver, Colorado 80206

United States

UCHealth Highlands Ranch Hospital

Highlands Ranch, Colorado 80129

United States