Breast Cancer
Conditions
Keywords
Early-Stage, Newly Diagnosed
Brief 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.
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.
Sponsors
University of Colorado, Denver
Association of Academic Surgery
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 100 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess the feasibility of prospectively providing a novel DA to early stage breast cancer patients | 1 year | 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. |
| Evaluate how well patients receive the decision aid | 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximize patient engagement with the decision aid | 1 year | 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. |
| 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. | 1 year | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSarah Tevis, MD
University of Colorado, Denver
Outcome results
None listed