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

September 1, 2026 updated by: University of Colorado, Denver

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

Active, not recruiting

Conditions

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Universtiy of Colorado Hospital
      • Denver, Colorado, United States, 80206
        • UCHealth Cherry Creek Medical Center
      • Highlands Ranch, Colorado, United States, 80129
        • UCHealth Highlands Ranch Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 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.
1 year
Evaluate how well patients receive the decision aid
Time Frame: 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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximize patient engagement with the decision aid
Time Frame: 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.
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.
Time Frame: 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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

Association of Academic Surgery

Investigators

  • Principal Investigator: Sarah Tevis, MD, University of Colorado, Denver

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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)

September 3, 2026

Last Update Submitted That Met QC Criteria

September 1, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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