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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
60
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 .
Electronic copy of an alternative educational pamphlet discussing surgical options for breast cancer.
Universtiy of Colorado Hospital
Aurora, Colorado, United States
RECRUITINGUCHealth Cherry Creek Medical Center
Denver, Colorado, United States
RECRUITINGUCHealth Highlands Ranch Hospital
Highlands Ranch, Colorado, United States
RECRUITINGAssess the feasibility of prospectively providing a novel DA to early stage breast cancer patients
Monitor the recruitment process of eligible patients. Including tracking how many patients are approached, how many participate and how effective the decision aid engages patient in the decision making process. High participation and engagement indicates a successful implementation. Compare clinician reported length of encounter between interventions as a balancing measure.
Time frame: 1 year
Evaluate how well patients receive the decision aid
Use the validated and accepted Ottawa Decision Aid metrics to assess decision quality, decisional conflict, acceptability, and regret. Conduct semi-structured interviews to gather additional qualitative data regarding the patient experience, and use feedback to modify and improve the content and design of the Decision Aid.
Time frame: 1 year
Maximize patient engagement with the decision aid
Optimal timing and mode of delivery will be determined by the engagement of patients with the decision aid (DA) based on the time the DA was offered. Qualitative feedback from semi-structured interviews will provide additional context for engagement with paper versus digital copies, and engagement prior to versus after meeting with the surgeon.
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.
Patient-reported Decision Aid Acceptability, Decision Quality, Self Efficacy, Decision Conflict, and Decision Regret (from the Ottawa Decision Aid Measures) as well as Patient-reported distress will be compared between intervention groups. Differences in these key outcomes will be used to perform a power analysis to determine optimal enrollment size for a large scale multicenter randomized controlled trial.
Time frame: 1 year
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