Increasing Patients' Engagement in Breast Cancer Surgery Decision-Making

Not Applicable

Active, not recruiting

Conditions: Breast Cancer Stage 0
Breast Cancer Stage II
Breast Cancer Stage III
Breast Cancer Stage I

Interventions: Other: Usual Care
Other: Web-based decision aid

Registration Number: NCT03766009

Lead Sponsor: Alliance for Clinical Trials in Oncology

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.

Recruitment & Eligibility

Status: ACTIVE_NOT_RECRUITING

Sex: Female

Target Recruitment: 627

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

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm II (web-based breast cancer surgery decision aid)	Usual Care	Following a 10 week implementation period, at the time of institutional crossover, participants will receive a web-based decision aid prior to the surgical consultation..
Arm II (web-based breast cancer surgery decision aid)	Web-based decision aid	Following a 10 week implementation period, at the time of institutional crossover, participants will receive a web-based decision aid prior to the surgical consultation..
Arm I (surgical consultation)	Usual Care	Prior to institutional crossover, participants receive care as per usual care.

Primary Outcome Measures

Name	Time	Method
Patient Power: Self-efficacy in Patient Physician Interactions	3 weeks	Power is defined as patients' self-perceived capacity to influence the decision-making encounter. This construct is measured using the Patient's Self-Efficacy in Patient-Physician Interactions (PEPPI)-5 point scale; the primary outcome measure is a total score ranging from 5-25, where higher scores indicate increased self-efficacy. The patient completes the PEPPI-5 questionnaire within 3 weeks post-surgical consultation.
Patient Power: Active Patient Participation	1 day	Power is also separately measured by the validated Active Patient Participation Behaviors System to assess active patient participation during the surgeon consultation and is measured off the audio-recording of the consultation; a summary measure of patient's active involvement in the interaction is coded by the study team and represents a total count of patients' communicative behaviors (i.e., count of patient asking questions, count of patient assertive responses and count of patient expressions of concern) ranging from 0-114, where higher scores indicate increased active patient participation. The consultation for a patient will typically be study day 1 (day of registration).

Secondary Outcome Measures

Name	Time	Method
Patient Knowledge	Up to 3 weeks	Patient knowledge is measured from 5 knowledge questions in the Decision Quality Instrument-Breast Surgery survey, with a percent correct recorded as the secondary outcome measure, ranging from 0-100%. The patient completes the Decision Quality Instrument-Breast Surgery survey within 3 weeks post-surgical consultation.
Concordance Between Personal Values and Surgery Received	Up to 3 weeks	This is a binary outcome reflecting whether surgery received (mastectomy; lumpectomy) was concordant or not with the patient's personal values. The patient's personal values are measured from 3 questions on the Decision Quality Instrument (DQI)-Breast Surgery survey; each question ranges from 0 (not at all important) to 10 (extremely important). . The patient completes the DQI within 3 weeks post-consultation. The method by Sepucha et al (2012) will be applied to determine concordance between personal values and surgery received.

Trial Locations

Locations (58): Epic Care-Dublin
🇺🇸
Dublin, California, United States
Bay Area Breast Surgeons Inc
🇺🇸
Emeryville, California, United States
Contra Costa Regional Medical Center
🇺🇸
Martinez, California, United States
Epic Care Partners in Cancer Care
🇺🇸
Emeryville, California, United States
Alta Bates Summit Medical Center - Summit Campus
🇺🇸
Oakland, California, United States
Epic Care Cyberknife Center
🇺🇸
Walnut Creek, California, United States
Bay Area Tumor Institute
🇺🇸
Oakland, 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
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
Carle on Vermilion
🇺🇸
Danville, Illinois, United States
John H Stroger Jr Hospital of Cook County
🇺🇸
Chicago, 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
University of New Mexico Cancer Center
🇺🇸
Albuquerque, New Mexico, United States
Saint Alphonsus Medical Center-Ontario
🇺🇸
Ontario, Oregon, United States
Saint Alphonsus Medical Center-Baker City
🇺🇸
Baker City, Oregon, United States
Marshfield Medical Center-Marshfield
🇺🇸
Marshfield, Wisconsin, United States
Pan American Center for Oncology Trials LLC
🇵🇷
San Juan, Puerto Rico
Welch Cancer Center
🇺🇸
Sheridan, Wyoming, United States
Billings Clinic-Cody
🇺🇸
Cody, Wyoming, United States
Community Hospital of Anaconda
🇺🇸
Anaconda, Montana, United States
Benefis Healthcare- Sletten Cancer Institute
🇺🇸
Great Falls, Montana, United States
Great Falls Clinic
🇺🇸
Great Falls, Montana, United States
Billings Clinic Cancer Center
🇺🇸
Billings, Montana, United States
Bozeman Deaconess Hospital
🇺🇸
Bozeman, Montana, United States
Saint Peter's Community Hospital
🇺🇸
Helena, Montana, United States
Community Medical Hospital
🇺🇸
Missoula, Montana, United States
Kalispell Regional Medical Center
🇺🇸
Kalispell, Montana, United States
FHP Health Center-Guam
🇬🇺
Tamuning, Guam
Ochsner Medical Center Jefferson
🇺🇸
New Orleans, Louisiana, 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
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