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Increasing Patients' Engageme...

Increasing Patients' Engagement in Breast Cancer Surgery Decision-Making

Last Updated: 2025-01-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

Total Enrollment

627 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-05

Study Completion Date

2026-12-15

Brief Summary

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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.

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Detailed Description

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The primary and secondary objectives of the study:

PRIMARY OBJECTIVES:

I. Test the effectiveness of a breast cancer surgery decision aid in increasing patient engagement in decision making (measured by knowledge and power) in clinics serving a high proportion of socioeconomically disadvantaged patients.

II. Test the extent to which the effect of a decision aid on patient engagement is mediated through the mitigation of barriers and determine if persistent barriers are disproportionately experienced by socioeconomically disadvantaged patients.

SECONDARY OBJECTIVES:

I. Characterize how persistent barriers influence patient engagement in decision making in order to identify targets for adjunct interventions that could be implemented in clinics serving a high proportion of socioeconomically disadvantaged patients.

Trial Design:

OUTLINE: This is a multi-site cluster randomized trial using a stepped wedge design. Ten clinics will be recruited for participation. All clinics will begin in the usual care arm. Clinics will be randomized to the timing with which they cross-over to the decision aid intervention, with new clinics crossing over every 10 weeks.

ARM I: usual care

ARM II: decision aid intervention

The only difference between patients enrolled before institutional crossover and patients enrolled after institutional crossover is those who are enrolled after institutional crossover will have been offered the decision aid as accepted practice in the clinic.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Institutional cross-over

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Arm I (surgical consultation)

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

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type OTHER

Usual Care

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

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..

Group Type EXPERIMENTAL

Usual Care

Intervention Type OTHER

Usual Care

Web-based decision aid

Intervention Type OTHER

Web-based decision aid received prior to the surgical consultation

Interventions

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Usual Care

Intervention Type OTHER

Web-based decision aid

Web-based decision aid received prior to the surgical consultation

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Heather B. Neuman,, MD, MS

Role: STUDY_CHAIR

University of Wisconsin, Madison

Locations

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Epic Care-Dublin

Dublin, California, United States

Site Status

Bay Area Breast Surgeons Inc

Emeryville, California, United States

Site Status

Epic Care Partners in Cancer Care

Emeryville, California, United States

Site Status

Contra Costa Regional Medical Center

Martinez, California, United States

Site Status

Alta Bates Summit Medical Center - Summit Campus

Oakland, California, United States

Site Status

Bay Area Tumor Institute

Oakland, California, United States

Site Status

Epic Care Cyberknife Center

Walnut Creek, California, United States

Site Status