RecruitingNot ApplicableNCT06813053

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


Sponsor

University of Colorado, Denver

Enrollment

60 participants

Start Date

Jul 21, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 100 Years

Inclusion Criteria4

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

Exclusion Criteria3

  • Prior surgical consultation regarding treatment options for breast cancer
  • Previous history of breast cancer
  • Requires neoadjuvant chemotherapy prior to surgical intervention

Interventions

OTHERDecision 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 .

OTHERStandard of Care (SOC)

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


Locations(3)

Universtiy of Colorado Hospital

Aurora, Colorado, United States

UCHealth Cherry Creek Medical Center

Denver, Colorado, United States

UCHealth Highlands Ranch Hospital

Highlands Ranch, Colorado, United States

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NCT06813053


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