A Novel Decision Aid for Early Stage Breast Cancer Patients Choosing Between Lumpectomy and Mastectomy: a Pilot Study
University of Colorado, Denver
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.
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
- Age range
- 18–100 years
- Sex
- Female
- Healthy volunteers
- No
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
- OtherDecision 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 .
- OtherStandard of Care (SOC)
Electronic copy of an alternative educational pamphlet discussing surgical options for breast cancer.
Locations (3)
- Universtiy of Colorado HospitalAurora, Colorado
- UCHealth Cherry Creek Medical CenterDenver, Colorado
- UCHealth Highlands Ranch HospitalHighlands Ranch, Colorado