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.

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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.

View Eligibility Criteria

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

Study is for people with:

Breast Cancer

Estimated Enrollment:

598

Study ID:

NCT03766009

Recruitment Status:

Active, not recruiting

Sponsor:

Alliance for Clinical Trials in Oncology

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There are 43 Locations for this study

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Epic Care-Dublin
Dublin California, 94568, United States
Bay Area Breast Surgeons Inc
Emeryville California, 94608, United States
Epic Care Partners in Cancer Care
Emeryville California, 94608, United States
Contra Costa Regional Medical Center
Martinez California, 94553, United States
Alta Bates Summit Medical Center - Summit Campus
Oakland California, 94609, United States
Bay Area Tumor Institute
Oakland California, 94609, United States
Epic Care Cyberknife Center
Walnut Creek California, 94597, United States
Augusta University Medical Center
Augusta Georgia, 30912, United States
Hawaii Cancer Care - Savio
'Aiea Hawaii, 96701, United States
Pali Momi Medical Center
'Aiea Hawaii, 96701, United States
Queen's Cancer Center - Pearlridge
'Aiea Hawaii, 96701, United States
The Cancer Center of Hawaii-Pali Momi
'Aiea Hawaii, 96701, United States
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu Hawaii, 96813, United States
Island Urology
Honolulu Hawaii, 96813, United States
Queen's Cancer Cenrer - POB I
Honolulu Hawaii, 96813, United States
Queen's Medical Center
Honolulu Hawaii, 96813, United States
Straub Clinic and Hospital
Honolulu Hawaii, 96813, United States
University of Hawaii Cancer Center
Honolulu Hawaii, 96813, United States
Hawaii Cancer Care Inc-Liliha
Honolulu Hawaii, 96817, United States
Kuakini Medical Center
Honolulu Hawaii, 96817, United States
Queen's Cancer Center - Kuakini
Honolulu Hawaii, 96817, United States
The Cancer Center of Hawaii-Liliha
Honolulu Hawaii, 96817, United States
Kapiolani Medical Center for Women and Children
Honolulu Hawaii, 96826, United States
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue Hawaii, 96766, United States
Saint Alphonsus Cancer Care Center-Boise
Boise Idaho, 83706, United States
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell Idaho, 83605, United States
Kootenai Health - Coeur d'Alene
Coeur d'Alene Idaho, 83814, United States
Walter Knox Memorial Hospital
Emmett Idaho, 83617, United States
Idaho Urologic Institute-Meridian
Meridian Idaho, 83642, United States
Saint Alphonsus Medical Center-Nampa
Nampa Idaho, 83686, United States
Kootenai Clinic Cancer Services - Post Falls
Post Falls Idaho, 83854, United States
Kootenai Cancer Clinic
Sandpoint Idaho, 83864, United States
John H Stroger Jr Hospital of Cook County
Chicago Illinois, 60612, United States
Carle on Vermilion
Danville Illinois, 61832, United States
Carle Physician Group-Effingham
Effingham Illinois, 62401, United States
Carle Physician Group-Mattoon/Charleston
Mattoon Illinois, 61938, United States
Carle Cancer Center
Urbana Illinois, 61801, United States
The Carle Foundation Hospital
Urbana Illinois, 61801, United States
Ochsner Medical Center Jefferson
New Orleans Louisiana, 70121, United States
Community Hospital of Anaconda
Anaconda Montana, 59711, United States
Billings Clinic Cancer Center
Billings Montana, 59101, United States
Bozeman Deaconess Hospital
Bozeman Montana, 59715, United States
Benefis Healthcare- Sletten Cancer Institute
Great Falls Montana, 59405, United States
Great Falls Clinic
Great Falls Montana, 59405, United States
Saint Peter's Community Hospital
Helena Montana, 59601, United States
Kalispell Regional Medical Center
Kalispell Montana, 59901, United States
Community Medical Hospital
Missoula Montana, 59804, United States
University of New Mexico Cancer Center
Albuquerque New Mexico, 87102, United States
Saint Alphonsus Medical Center-Baker City
Baker City Oregon, 97814, United States
Saint Alphonsus Medical Center-Ontario
Ontario Oregon, 97914, United States
Medical University of South Carolina
Charleston South Carolina, 29425, United States
VCU Massey Cancer Center at Stony Point
Richmond Virginia, 23235, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond Virginia, 23298, United States
Marshfield Medical Center-Marshfield
Marshfield Wisconsin, 54449, United States
Billings Clinic-Cody
Cody Wyoming, 82414, United States
Welch Cancer Center
Sheridan Wyoming, 82801, United States
FHP Health Center-Guam
Tamuning , 96913, Guam
Pan American Center for Oncology Trials LLC
San Juan , 00902, Puerto Rico

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

598

Study ID:

NCT03766009

Recruitment Status:

Active, not recruiting

Sponsor:


Alliance for Clinical Trials in Oncology

How clear is this clinincal trial information?

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