NCT06813053

A Novel Patient Decision Aid for Surgical Treatment Options in Early-Stage Breast Cancer

A Novel Decision Aid for Early Stage Breast Cancer Patients Choosing Between Lumpectomy and Mastectomy: a Pilot Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: Female
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-07-21
• Primary completion: 2026-12-01
• Completion: 2027-03-01
• First posted: 2025-02-06
• Last updated: 2025-08-12

Locations

3 sites across 1 country: United States