Breast Cancer Clinical Trial
Increasing Patients’ Engagement in Breast Cancer Surgery Decision-Making
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.
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.
Eligibility 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
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There are 43 Locations for this study
Dublin California, 94568, United States
Emeryville California, 94608, United States
Emeryville California, 94608, United States
Martinez California, 94553, United States
Oakland California, 94609, United States
Oakland California, 94609, United States
Walnut Creek California, 94597, United States
Augusta Georgia, 30912, United States
'Aiea Hawaii, 96701, United States
'Aiea Hawaii, 96701, United States
'Aiea Hawaii, 96701, United States
'Aiea Hawaii, 96701, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96817, United States
Honolulu Hawaii, 96817, United States
Honolulu Hawaii, 96817, United States
Honolulu Hawaii, 96817, United States
Honolulu Hawaii, 96826, United States
Lihue Hawaii, 96766, United States
Boise Idaho, 83706, United States
Caldwell Idaho, 83605, United States
Coeur d'Alene Idaho, 83814, United States
Emmett Idaho, 83617, United States
Meridian Idaho, 83642, United States
Nampa Idaho, 83686, United States
Post Falls Idaho, 83854, United States
Sandpoint Idaho, 83864, United States
Chicago Illinois, 60612, United States
Danville Illinois, 61832, United States
Effingham Illinois, 62401, United States
Mattoon Illinois, 61938, United States
Urbana Illinois, 61801, United States
Urbana Illinois, 61801, United States
New Orleans Louisiana, 70121, United States
Anaconda Montana, 59711, United States
Billings Montana, 59101, United States
Bozeman Montana, 59715, United States
Great Falls Montana, 59405, United States
Great Falls Montana, 59405, United States
Helena Montana, 59601, United States
Kalispell Montana, 59901, United States
Missoula Montana, 59804, United States
Albuquerque New Mexico, 87102, United States
Baker City Oregon, 97814, United States
Ontario Oregon, 97914, United States
Charleston South Carolina, 29425, United States
Richmond Virginia, 23235, United States
Richmond Virginia, 23298, United States
Marshfield Wisconsin, 54449, United States
Cody Wyoming, 82414, United States
Sheridan Wyoming, 82801, United States
Tamuning , 96913, Guam
San Juan , 00902, Puerto Rico
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