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

University of Colorado Denver (CU Denver)

Status: Enrolling

Conditions: Breast Cancer

Treatments: Other: Standard of Care (SOC); Other: Decision Aid (DA)

Study type: Interventional

Funder types: Other

Identifiers

NCT06813053

NCT-2025-02972 (Other Identifier)

25-0577.cc

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups, including a placebo group

Interventional Group

Experimental group

Description:

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.

Treatment:

Other: Decision Aid (DA)

Control Group

Placebo Comparator group

Description:

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.

Treatment:

Other: Standard of Care (SOC)