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A Novel Patient Decision Aid for Surgical Treatment Options in Early-Stage Breast Cancer
NCT06813053 · University of Colorado, Denver
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
A Novel Decision Aid for Early Stage Breast Cancer Patients Choosing Between Lumpectomy and Mastectomy: a Pilot Study
About this study
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
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
Study design
Enrollment target: 60 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-07-21
Estimated completion: 2027-03
Last updated: 2025-08-12
Interventions
Other: Decision Aid (DA)Other: Standard of Care (SOC)
Primary outcomes
- • Assess the feasibility of prospectively providing a novel DA to early stage breast cancer patients (1 year)
- • Evaluate how well patients receive the decision aid (1 year)
Sponsor
University of Colorado, Denver · other
With: Association of Academic Surgery
Contacts & investigators
ContactJakob Durden, MD · contact · jakob.durden@cuanschutz.edu · 1-719-751-8466
InvestigatorSarah Tevis, MD · principal_investigator, University of Colorado, Denver
All locations (3)
Universtiy of Colorado HospitalRecruiting
Aurora, Colorado, United States
UCHealth Cherry Creek Medical CenterRecruiting
Denver, Colorado, United States
UCHealth Highlands Ranch HospitalRecruiting
Highlands Ranch, Colorado, United States