Increasing Patients' Engagement in Breast Cancer Surgery Decision-Making

Alliance for Clinical Trials in Oncology

Status: Active, not recruiting

Conditions: Breast Cancer Stage II; Breast Cancer Stage 0; Breast Cancer Stage I; Breast Cancer Stage III

Treatments: Other: Usual Care; Other: Web-based decision aid

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; NIH

Identifiers

NCT03766009

NCI-2018-00643 (Registry Identifier)

A231701CD

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 627 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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627 participants in 2 patient groups

Arm I (surgical consultation)

Active Comparator group

Description:

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

Treatment:

Other: Usual Care

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

Experimental group

Description:

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..

Treatment:

Other: Web-based decision aid

Other: Usual Care