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

NCT06813053 | Recruiting DMC

• 2 other identifiers: 25-0577.ccNCT-2025-02972
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Breast Cancer

Keywords

Early-Stage; Newly Diagnosed

Outcome Measures

Primary Outcomes (2)

• Assess the feasibility of prospectively providing a novel DA to early stage breast cancer patients

  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.

  1 year

• Evaluate how well patients receive the decision aid

  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.

  1 year

Secondary Outcomes (2)

• Maximize patient engagement with the decision aid

  1 year

• 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.

  1 year

Study Arms (2)

Interventional Group

EXPERIMENTAL

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.

Other: Decision Aid (DA)

Control Group

PLACEBO COMPARATOR

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.

Other: Standard of Care (SOC)

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 .

Interventional Group

Standard of Care (SOC) OTHER

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

Control Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Association of Academic Surgery: collaborator

Study Sites (3)

Universtiy of Colorado Hospital

Aurora, Colorado, 80045, United States

RECRUITING

UCHealth Cherry Creek Medical Center

Denver, Colorado, 80206, United States

RECRUITING

UCHealth Highlands Ranch Hospital

Highlands Ranch, Colorado, 80129, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Decision Support Techniques; Standard of Care

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Sarah Tevis, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jakob Durden, MD

CONTACT

1-719-751-8466; jakob.durden@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 6, 2025
• Study Start: July 21, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: August 12, 2025

Record last verified: 2025-08

Locations

US (3)