Spots Global Cancer Trial Database for Increasing Patients' Engagement in Breast Cancer Surgery Decision-Making
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Trial Identification
Brief Title: Increasing Patients' Engagement in Breast Cancer Surgery Decision-Making
Official Title: Increasing Socioeconomically Disadvantaged Patients' Engagement in Breast Cancer Surgery Decision Making Through a Shared Decision Making Intervention
Study ID: NCT03766009
Study Description
Brief 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.
Detailed 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Epic Care-Dublin, Dublin, California, United States
Bay Area Breast Surgeons Inc, Emeryville, California, United States
Epic Care Partners in Cancer Care, Emeryville, California, United States
Contra Costa Regional Medical Center, Martinez, California, United States
Alta Bates Summit Medical Center - Summit Campus, Oakland, California, United States
Bay Area Tumor Institute, Oakland, California, United States
Epic Care Cyberknife Center, Walnut Creek, California, United States
Augusta University Medical Center, Augusta, Georgia, United States
Hawaii Cancer Care - Savio, 'Aiea, Hawaii, United States
Pali Momi Medical Center, 'Aiea, Hawaii, United States
Queen's Cancer Center - Pearlridge, 'Aiea, Hawaii, United States
The Cancer Center of Hawaii-Pali Momi, 'Aiea, Hawaii, United States
Hawaii Cancer Care Inc - Waterfront Plaza, Honolulu, Hawaii, United States
Island Urology, Honolulu, Hawaii, United States
Queen's Cancer Cenrer - POB I, Honolulu, Hawaii, United States
Queen's Medical Center, Honolulu, Hawaii, United States
Straub Clinic and Hospital, Honolulu, Hawaii, United States
University of Hawaii Cancer Center, Honolulu, Hawaii, United States
Hawaii Cancer Care Inc-Liliha, Honolulu, Hawaii, United States
Kuakini Medical Center, Honolulu, Hawaii, United States
Queen's Cancer Center - Kuakini, Honolulu, Hawaii, United States
The Cancer Center of Hawaii-Liliha, Honolulu, Hawaii, United States
Kapiolani Medical Center for Women and Children, Honolulu, Hawaii, United States
Wilcox Memorial Hospital and Kauai Medical Clinic, Lihue, Hawaii, United States
Saint Alphonsus Cancer Care Center-Boise, Boise, Idaho, United States
Saint Alphonsus Cancer Care Center-Caldwell, Caldwell, Idaho, United States
Kootenai Health - Coeur d'Alene, Coeur d'Alene, Idaho, United States
Walter Knox Memorial Hospital, Emmett, Idaho, United States
Idaho Urologic Institute-Meridian, Meridian, Idaho, United States
Saint Alphonsus Medical Center-Nampa, Nampa, Idaho, United States
Kootenai Clinic Cancer Services - Post Falls, Post Falls, Idaho, United States
Kootenai Cancer Clinic, Sandpoint, Idaho, United States
John H Stroger Jr Hospital of Cook County, Chicago, Illinois, United States
Carle on Vermilion, Danville, Illinois, United States
Carle Physician Group-Effingham, Effingham, Illinois, United States
Carle Physician Group-Mattoon/Charleston, Mattoon, Illinois, United States
Carle Cancer Center, Urbana, Illinois, United States
The Carle Foundation Hospital, Urbana, Illinois, United States
Ochsner Medical Center Jefferson, New Orleans, Louisiana, United States
Community Hospital of Anaconda, Anaconda, Montana, United States
Billings Clinic Cancer Center, Billings, Montana, United States
Bozeman Deaconess Hospital, Bozeman, Montana, United States
Benefis Healthcare- Sletten Cancer Institute, Great Falls, Montana, United States
Great Falls Clinic, Great Falls, Montana, United States
Saint Peter's Community Hospital, Helena, Montana, United States
Kalispell Regional Medical Center, Kalispell, Montana, United States
Community Medical Hospital, Missoula, Montana, United States
University of New Mexico Cancer Center, Albuquerque, New Mexico, United States
Saint Alphonsus Medical Center-Baker City, Baker City, Oregon, United States
Saint Alphonsus Medical Center-Ontario, Ontario, Oregon, United States
Medical University of South Carolina, Charleston, South Carolina, United States
VCU Massey Cancer Center at Stony Point, Richmond, Virginia, United States
Virginia Commonwealth University/Massey Cancer Center, Richmond, Virginia, United States
Marshfield Medical Center-Marshfield, Marshfield, Wisconsin, United States
Billings Clinic-Cody, Cody, Wyoming, United States
Welch Cancer Center, Sheridan, Wyoming, United States
FHP Health Center-Guam, Tamuning, , Guam
Pan American Center for Oncology Trials LLC, San Juan, , Puerto Rico
Contact Details
Name: Heather B. Neuman,, MD, MS
Affiliation: University of Wisconsin, Madison
Role: STUDY_CHAIR
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