Clinical trial NCT03766009: 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 type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer Stage 0
Breast Cancer Stage I
Breast Cancer Stage II
Breast Cancer Stage III
Lead sponsor: Alliance for Clinical Trials in Oncology
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2018-12-05
Enrollment: 627
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Institutional cross-over
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Patient Power: Self-efficacy in Patient Physician Interactions
timeFrame: 3 weeks
measure: Patient Power: Active Patient Participation
timeFrame: 1 day
Secondary outcomes:
measure: Patient Knowledge
timeFrame: Up to 3 weeks
measure: Concordance Between Personal Values and Surgery Received
timeFrame: Up to 3 weeks
Other outcomes:
Locations:
city: Dublin
country: United States
facility: Epic Care-Dublin
state: California
city: Emeryville
country: United States
facility: Bay Area Breast Surgeons Inc
state: California
city: Emeryville
country: United States
facility: Epic Care Partners in Cancer Care
state: California
city: Martinez
country: United States
facility: Contra Costa Regional Medical Center
state: California
city: Oakland
country: United States
facility: Alta Bates Summit Medical Center - Summit Campus
state: California
city: Oakland
country: United States
facility: Bay Area Tumor Institute
state: California
city: Walnut Creek
country: United States
facility: Epic Care Cyberknife Center
state: California
city: Augusta
country: United States
facility: Augusta University Medical Center
state: Georgia
city: 'Aiea
country: United States
facility: Hawaii Cancer Care - Savio
state: Hawaii
city: 'Aiea
country: United States
facility: Pali Momi Medical Center
state: Hawaii
city: 'Aiea
country: United States
facility: Queen's Cancer Center - Pearlridge
state: Hawaii
city: 'Aiea
country: United States
facility: The Cancer Center of Hawaii-Pali Momi
state: Hawaii
city: Honolulu
country: United States
facility: Hawaii Cancer Care Inc - Waterfront Plaza
state: Hawaii
city: Honolulu
country: United States
facility: Island Urology
state: Hawaii
city: Honolulu
country: United States
facility: Queen's Cancer Cenrer - POB I
state: Hawaii
city: Honolulu
country: United States
facility: Queen's Medical Center
state: Hawaii
city: Honolulu
country: United States
facility: Straub Clinic and Hospital
state: Hawaii
city: Honolulu
country: United States
facility: University of Hawaii Cancer Center
state: Hawaii
city: Honolulu
country: United States
facility: Hawaii Cancer Care Inc-Liliha
state: Hawaii
city: Honolulu
country: United States
facility: Kuakini Medical Center
state: Hawaii
city: Honolulu
country: United States
facility: Queen's Cancer Center - Kuakini
state: Hawaii
city: Honolulu
country: United States
facility: The Cancer Center of Hawaii-Liliha
state: Hawaii
city: Honolulu
country: United States
facility: Kapiolani Medical Center for Women and Children
state: Hawaii
city: Lihue
country: United States
facility: Wilcox Memorial Hospital and Kauai Medical Clinic
state: Hawaii
city: Boise
country: United States
facility: Saint Alphonsus Cancer Care Center-Boise
state: Idaho
city: Caldwell
country: United States
facility: Saint Alphonsus Cancer Care Center-Caldwell
state: Idaho
city: Coeur d'Alene
country: United States
facility: Kootenai Health - Coeur d'Alene
state: Idaho
city: Emmett
country: United States
facility: Walter Knox Memorial Hospital
state: Idaho
city: Meridian
country: United States
facility: Idaho Urologic Institute-Meridian
state: Idaho
city: Nampa
country: United States
facility: Saint Alphonsus Medical Center-Nampa
state: Idaho
city: Post Falls
country: United States
facility: Kootenai Clinic Cancer Services - Post Falls
state: Idaho
city: Sandpoint
country: United States
facility: Kootenai Cancer Clinic
state: Idaho
city: Chicago
country: United States
facility: John H Stroger Jr Hospital of Cook County
state: Illinois
city: Danville
country: United States
facility: Carle on Vermilion
state: Illinois
city: Effingham
country: United States
facility: Carle Physician Group-Effingham
state: Illinois
city: Mattoon
country: United States
facility: Carle Physician Group-Mattoon/Charleston
state: Illinois
city: Urbana
country: United States
facility: Carle Cancer Center
state: Illinois
city: Urbana
country: United States
facility: The Carle Foundation Hospital
state: Illinois
city: New Orleans
country: United States
facility: Ochsner Medical Center Jefferson
state: Louisiana
city: Anaconda
country: United States
facility: Community Hospital of Anaconda
state: Montana
city: Billings
country: United States
facility: Billings Clinic Cancer Center
state: Montana
city: Bozeman
country: United States
facility: Bozeman Deaconess Hospital
state: Montana
city: Great Falls
country: United States
facility: Benefis Healthcare- Sletten Cancer Institute
state: Montana
city: Great Falls
country: United States
facility: Great Falls Clinic
state: Montana
city: Helena
country: United States
facility: Saint Peter's Community Hospital
state: Montana
city: Kalispell
country: United States
facility: Kalispell Regional Medical Center
state: Montana
city: Missoula
country: United States
facility: Community Medical Hospital
state: Montana
city: Albuquerque
country: United States
facility: University of New Mexico Cancer Center
state: New Mexico
city: Baker City
country: United States
facility: Saint Alphonsus Medical Center-Baker City
state: Oregon
city: Ontario
country: United States
facility: Saint Alphonsus Medical Center-Ontario
state: Oregon
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Richmond
country: United States
facility: VCU Massey Cancer Center at Stony Point
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University/Massey Cancer Center
state: Virginia
city: Marshfield
country: United States
facility: Marshfield Medical Center-Marshfield
state: Wisconsin
city: Cody
country: United States
facility: Billings Clinic-Cody
state: Wyoming
city: Sheridan
country: United States
facility: Welch Cancer Center
state: Wyoming
city: Tamuning
country: Guam
facility: FHP Health Center-Guam
city: San Juan
country: Puerto Rico
facility: Pan American Center for Oncology Trials LLC
Study officials:
affiliation: University of Wisconsin, Madison
name: Heather B. Neuman,, MD, MS
role: STUDY_CHAIR
References:
citation: Schumacher JR, Zahrieh D, Chow S, Taylor J, Wills R, Hanlon BM, Rathouz PJ, Tucholka JL, Neuman HB. Increasing socioeconomically disadvantaged patients' engagement in breast cancer surgery decision-making through a shared decision-making intervention (A231701CD): protocol for a cluster randomised clinical trial. BMJ Open. 2022 Nov 17;12(11):e063895. doi: 10.1136/bmjopen-2022-063895.