Decision Aid for Early-Stage Breast Cancer Surgical Options

This study is testing a new tool called a Decision Aid (DA) to help women with early-stage breast cancer choose their surgical treatment. The DA helps you understand the risks and benefits of different options, like lumpectomy or mastectomy, and considers your personal values. Researchers want to see if this DA is easy to use and helpful compared to a standard educational pamphlet. They will gather feedback from about 60 women aged 18-100 who speak English and are eligible for both lumpectomy and mastectomy. The goal is to improve the DA and plan for a larger study in the future. The current recruitment status is unclear.

Study design
This is an interventional study involving about 60 participants. It compares a new Decision Aid (DA) to a Standard of Care (SOC) educational pamphlet.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Researchers will assess the feasibility and how well patients receive the decision aid for up to 1 year.

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NCT06813053

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

Recruiting
NAAges 18+InterventionalSupportive care
University of Colorado, Denver
~60 participants
Updated 2025-08-12 on ClinicalTrials.gov
What's tested:Decision Aid (DA)Standard of Care (SOC)

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Assess the feasibility of prospectively providing a novel DA to early stage breast cancer patients
Measured over 1 year
+1 more outcome measured
Breast Cancer
3 sites across 1 states
Colorado3
  • Sarah Tevis, MD · PRINCIPAL_INVESTIGATOR · University of Colorado, Denver

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Eligibility criteria

Inclusion

Adult women age 18-100
English speaking
Clinical stage 0-III breast cancer
Eligible for both lumpectomy and mastectomy

Exclusion

Prior surgical consultation regarding treatment options for breast cancer
Previous history of breast cancer
Requires neoadjuvant chemotherapy prior to surgical intervention
  • Assess the feasibility of prospectively providing a novel DA to early stage breast cancer patients1 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 aid1 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.