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NCT Number: NCT06813053

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

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.

Recruiting

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Key information

Age range

18 year–100 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Universtiy of Colorado Hospital, Aurora, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Decision Aid (DA)

Other

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 .

Standard of Care (SOC)

Other

Electronic copy of an alternative educational pamphlet discussing surgical options for breast cancer.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jakob Durden, MD

CONTACT

[email protected]

1-719-751-8466

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Association of Academic Surgery

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Feb 6, 2025
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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