Brief Summary

This trial studies how well a breast cancer surgery decision aid works in increasing patient engagement in decision making for patients with newly diagnosed stage 0-III breast cancer. The trial also examines barriers to patient engagement even with the use of a decision aid, and if barriers are more likely to be experienced by socioeconomically disadvantaged patients.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

627

participants targeted

Target at P75+ for not_applicable

Timeline

8mo left

Started Jun 2019

Longer than P75 for not_applicable

Geographic Reach

3 countries

58 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

7.5 years study duration

Study Progress92%

Jun 2019Dec 2026

First Submitted

Initial submission to the registry

November 30, 2018

Completed

5 days until next milestone

First Posted

Study publicly available on registry

December 5, 2018

Completed

6 months until next milestone

Study Start

First participant enrolled

June 5, 2019

Completed

3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 26, 2023

Completed

1.6 years until next milestone

Results Posted

Study results publicly available

August 27, 2024

Completed

2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2026

Expected

Last Updated

February 11, 2026

Status Verified

January 1, 2026

Enrollment Period

3.6 years

First QC Date

November 30, 2018

Results QC Date

October 2, 2023

Last Update Submit

January 23, 2026

Conditions

Breast Cancer Stage 0 Breast Cancer Stage I Breast Cancer Stage II Breast Cancer Stage III

Outcome Measures

Primary Outcomes (2)

Patient Power: Self-efficacy in Patient Physician Interactions
Power is defined as patients' self-perceived capacity to influence the decision-making encounter. This construct is measured using the Patient's Self-Efficacy in Patient-Physician Interactions (PEPPI)-5 point scale; the primary outcome measure is a total score ranging from 5-25, where higher scores indicate increased self-efficacy. The patient completes the PEPPI-5 questionnaire within 3 weeks post-surgical consultation.
3 weeks
Patient Power: Active Patient Participation
Power is also separately measured by the validated Active Patient Participation Behaviors System to assess active patient participation during the surgeon consultation and is measured off the audio-recording of the consultation; a summary measure of patient's active involvement in the interaction is coded by the study team and represents a total count of patients' communicative behaviors (i.e., count of patient asking questions, count of patient assertive responses and count of patient expressions of concern) ranging from 0-114, where higher scores indicate increased active patient participation. The consultation for a patient will typically be study day 1 (day of registration).
1 day

Secondary Outcomes (2)

Patient Knowledge
Up to 3 weeks
Concordance Between Personal Values and Surgery Received
Up to 3 weeks

Study Arms (2)

Arm I (surgical consultation)

ACTIVE COMPARATOR

Prior to institutional crossover, participants receive care as per usual care.

Other: Usual Care

Arm II (web-based breast cancer surgery decision aid)

EXPERIMENTAL

Following a 10 week implementation period, at the time of institutional crossover, participants will receive a web-based decision aid prior to the surgical consultation..

Other: Usual CareOther: Web-based decision aid

Interventions

Usual CareOTHER

Usual Care

Arm I (surgical consultation)Arm II (web-based breast cancer surgery decision aid)

Web-based decision aidOTHER

Web-based decision aid received prior to the surgical consultation

Arm II (web-based breast cancer surgery decision aid)

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Newly diagnosed with stage 0-III breast cancer
Eligible patients must be planning breast surgery as a component of their definitive treatment
Patients with impaired decision-making capacity (such as with a diagnosis of dementia or memory loss) are not eligible for this study
Patients with hearing impairment requiring the use of an interpreter are not eligible for this study
Patients must be able to speak English with the fluency required to have a direct discussion around treatment decision-making (i.e. without interpreter)
CLINIC STAKEHOLDER (SURGEONS AND CLINIC STAFF): Breast surgeon(s) and nursing staff, medical assistant, or mid-level provider at each participating clinic who participates in the care of patients newly diagnosed with breast cancer
INSTITUTIONAL: 10 clinics that annually provide surgical care for 120-300 patients newly diagnosed with breast cancer will be selected to participate in this study
INSTITUTIONAL: Surgeons at eligible clinics must consent to the study as a requirement for site participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Alliance for Clinical Trials in Oncologylead
National Cancer Institute (NCI)collaborator
Agency for Healthcare Research and Quality (AHRQ)collaborator

Study Sites (58)

Epic Care-Dublin

Dublin, California, 94568, United States

Location

Bay Area Breast Surgeons Inc

Emeryville, California, 94608, United States

Location

Epic Care Partners in Cancer Care

Emeryville, California, 94608, United States

Location

Contra Costa Regional Medical Center

Martinez, California, 94553-3156, United States

Location

Alta Bates Summit Medical Center - Summit Campus

Oakland, California, 94609, United States

Location

Bay Area Tumor Institute

Oakland, California, 94609, United States

Location

Epic Care Cyberknife Center

Walnut Creek, California, 94597, United States

Location

Augusta University Medical Center

Augusta, Georgia, 30912, United States

Location

Hawaii Cancer Care Inc - Waterfront Plaza