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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Decision Aid (DA); Other: Standard of Care (SOC)

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jakob Durden, MD; Phone Number: 1-719-751-8466; Email: jakob.durden@cuanschutz.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • Universtiy of Colorado Hospital
      • Principal Investigator: Sarah Tevis, MD
      • Contact: Jakob Durden, MD; Phone Number: 1-719-751-8466; Email: jakob.durden@cuanschutz.edu
    • Denver, Colorado, United States, 80206
      • Recruiting
      • UCHealth Cherry Creek Medical Center
      • Contact: Jakob Durden, MD; Phone Number: 1-719-751-8466; Email: jakob.durden@cuanschutz.edu
      • Sub-Investigator: Nicole Christian, MD
    • Highlands Ranch, Colorado, United States, 80129
      • Recruiting
      • UCHealth Highlands Ranch Hospital
      • Contact: Jakob Durden, MD; Phone Number: 1-719-751-8466; Email: jakob.durden@cuanschutz.edu
      • Sub-Investigator: Jodi Widner, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional Group; Newly detected, early stage breast cancer patients in the treatment group will be provided an electronic copy of the DA for their reference via email.	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 .
Placebo Comparator: Control Group; Newly diagnosed, early stage breast cancer patients in the control group will be provided an electronic copy of an alternative educational pamphlet discussing surgical options for breast cancer.	Other: Standard of Care (SOC); Electronic copy of an alternative educational pamphlet discussing surgical options for breast cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess 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.	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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	1 year

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Association of Academic Surgery
• Investigators: Principal Investigator: Sarah Tevis, MD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: February 3, 2025
• First Submitted That Met QC Criteria: February 3, 2025
• First Posted (Actual): February 6, 2025

Study Record Updates

• Last Update Posted (Actual): August 12, 2025
• Last Update Submitted That Met QC Criteria: August 11, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Newly Diagnosed; Early-Stage
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 25-0577.cc; NCT-2025-02972 (Other Identifier: CTRP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No