A Novel Patient Decision Aid for Surgical Treatment Options in Early-Stage Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Decision Aid (DA), Standard of Care (SOC).
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: 18 years — 100 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Novel Decision Aid for Early Stage Breast Cancer Patients Choosing Between Lumpectomy and Mastectomy: a Pilot Study
Overview
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.
Interventions
- Other Decision Aid (DA)
Tools designed to foster shared decision-making by contextualizing the risks and benefits of treatment options around the patient's personal values, thereby allowing them to weigh personal preferences when making treatment decisions. The study team has developed a prototype DA incorporating longitudinal institutional QoL data among patients who have undergone breast cancer surgery . - Other Standard of Care (SOC)
Electronic copy of an alternative educational pamphlet discussing surgical options for breast cancer.
Primary outcome measures
- Assess the feasibility of prospectively providing a novel DA to early stage breast cancer patients [Time frame: 1 year]
- Evaluate how well patients receive the decision aid [Time frame: 1 year]
Secondary outcome measures (2)
- Maximize patient engagement with the decision aid [Time frame: 1 year]
- Obtain pilot data for a large scale randomized controlled trial comparing use of the decision aid to standard of care in early-stage breast cancer patients. [Time frame: 1 year]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 3 centers
- Universtiy of Colorado Hospital — Aurora
- UCHealth Cherry Creek Medical Center — Denver
- UCHealth Highlands Ranch Hospital — Highlands Ranch
Identifiers
NCT: NCT06813053 · 25-0577.cc · NCT-2025-02972