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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT06813053
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jul 21, 2025
Status verified
Aug 2025
Primary completion
Dec 31, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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.
  • 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.

Primary Outcome Measure

Assess the feasibility of prospectively providing a novel DA to early stage breast cancer patients [ Time Frame: 1 year ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Universtiy of Colorado HospitalAuroraColorado80045
Jakob Durden, MD
[email protected]
1-719-751-8466
Sarah Tevis, MD (PRINCIPAL_INVESTIGATOR)
UCHealth Cherry Creek Medical CenterDenverColorado80206
Jakob Durden, MD
[email protected]
1-719-751-8466
Nicole Christian, MD (SUB_INVESTIGATOR)
UCHealth Highlands Ranch HospitalHighlands RanchColorado80129
Jakob Durden, MD
[email protected]
1-719-751-8466
Jodi Widner, MD (SUB_INVESTIGATOR)

Find similar trials in Aurora, CO

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Universtiy of Colorado Hospital· Aurora, COUCHealth Cherry Creek Medical Center· Denver, COUCHealth Highlands Ranch Hospital· Highlands Ranch, CO

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