Increasing Patients' Engagement in Breast Cancer Surgery Decision-Making

  • STATUS
    Recruiting
  • End date
    Dec 18, 2022
  • participants needed
    1050
  • sponsor
    Alliance for Clinical Trials in Oncology
Updated on 18 October 2020
Investigator
Heather B. Neuman, MD, MS
Primary Contact
Epic Care Cyberknife Center (0.7 mi away) Contact
+60 other location
breast surgery
hearing impairment

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.

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.

Details
Treatment Usual Care, Web-based decision aid
Clinical Study IdentifierNCT03766009
SponsorAlliance for Clinical Trials in Oncology
Last Modified on18 October 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Are you female?
Do you have any of these conditions: Breast Cancer Stage III or Breast Cancer Stage I or Breast Cancer Stage II or Breast Cancer Stage 0?
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
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