Improving Patient-Centered Communication in Breast Cancer Through Patient and Provider Interventions
NCT ID: NCT04549571
Last Updated: 2025-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
543 participants
INTERVENTIONAL
2021-02-16
2027-01-31
Brief Summary
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Detailed Description
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PRIMARY OBJECTIVES:
I. To demonstrate that the enhanced iCanDecide (iCanDecide-emotional support enhancement \[ESE\]) intervention is more effective than the standard version (iCanDecide-standard \[S\]) resulting in higher patient knowledge about locoregional treatment risks and benefits.
II. To demonstrate that the activation of the clinician dashboard (CDB) is more effective than not using a CDB, resulting in higher patient knowledge about locoregional treatment risks and benefits.
SECONDARY OBJECTIVES:
I. To demonstrate that the enhanced iCanDecide (iCanDecide-ESE) intervention is more effective than the standard version (iCanDecide-S), resulting in higher patient-reported breast cancer self-efficacy and lower patient reported cancer worry.
II. To demonstrate that the activation of the clinician dashboard (CDB) is more effective than not using a CDB, resulting in higher patient-reported breast cancer self-efficacy and lower patient reported cancer worry.
OUTLINE: This study is a multi-level trial of SHaDES that has two interventions in a factorial or crossed design: 1) an individually randomized patient-level randomized controlled trial (RCT) to evaluate the standard version (iCanDecide-S) vs. a version with innovative emotional support enhancements (iCanDecide-ESE), and 2) a clinic-level stepped-wedge cluster randomized trial to test a Clinician Dashboard (CDB). Twenty-five surgical practices will be recruited for participation. Practices will be randomized to the timing of the CDB intervention, with some practices initiating the CDB intervention right away, while others may initiate the CDB later or perhaps be randomized to "no CDB" period. Clinicians will be asked to use the CDB beginning in the time period to which their practice was randomized and continuing to the end of the study. After registration, clinicians are followed up at 9 and 18 months. After a patient is registered, the patient will be randomized to one of two arms:
ARM I: Patients utilize the iCanDecide - ESE website, then undergo surgery within 5 weeks of registration. Patients may also participate in an audio-recorded phone interview over 20 minutes at 9-12 months post registration.
ARM II: Patients utilize the iCanDecide - S website, then undergo surgery within 5 weeks of registration. Patients may also participate in an audio-recorded phone interview over 20 minutes at 9-12 months post registration.
After study registration, patients are followed up at 4-5 weeks and 9 months.
Patients will be enrolled at participating clinics during the full duration of the study and all enrolled patients will receive a version of the decision support tool (iCanDecide-S; iCanDecide-ESE). These patient-level activities are not influenced by the timing of the practice-level randomization to the CDB.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
HEALTH_SERVICES_RESEARCH
DOUBLE
Study Groups
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Arm I: (iCanDecide - ESE)
Patients utilize the iCanDecide - ESE website, then undergo surgery within 5 weeks of registration. Patients may also participate in an audio-recorded phone interview over 20 minutes at 9-12 months post registration.
Decision Aid iCanDecide - ESE website
Utilize the iCanDecide - ESE website
Therapeutic Conventional Surgery
Undergo surgery
Interview
Participate in interview
Survey Administration
Ancillary studies
Quality-of-Life Assessment
Ancillary studies
Arm II: (iCanDecide - S)
Patients utilize the iCanDecide - S website, then undergo surgery within 5 weeks of registration. Patients may also participate in an audio-recorded phone interview over 20 minutes at 9-12 months post registration.
Decision Aid iCanDecide - S website
Utilize the iCanDecide - S website
Therapeutic Conventional Surgery
Undergo surgery
Interview
Participate in interview
Survey Administration
Ancillary studies
Quality-of-Life Assessment
Ancillary studies
Clinics 1-5: (CDB)
Beginning 4 weeks before the practice begins use of the CDB, clinicians receive training on how to use the CDB and utilize the CDB over weeks 1-60. Clinicians may also participate in an audio-recorded phone interview over 20 minutes.
Interview
Participate in interview
Training
Receive training
Media Intervention
Utilize the CDB
Survey Administration
Ancillary studies
Clinics 6-8 (CDB)
Beginning 4 weeks before the practice begins use of the CDB, clinicians receive training on how to use the CDB and utilize the CDB over weeks 10-60. Clinicians may also participate in an audio-recorded phone interview over 20 minutes.
Interview
Participate in interview
Training
Receive training
Media Intervention
Utilize the CDB
Survey Administration
Ancillary studies
Clinics 9-11 (CDB)
Beginning 4 weeks before the practice begins use of the CDB, clinicians receive training on how to use the CDB and utilize the CDB over weeks 20-60. Clinicians may also participate in an audio-recorded phone interview over 20 minutes.
Interview
Participate in interview
Training
Receive training
Media Intervention
Utilize the CDB
Survey Administration
Ancillary studies
Clinics 12-14 (CDB)
Beginning 4 weeks before the practice begins use of the CDB, clinicians receive training on how to use the CDB and utilize the CDB over weeks 30-60. Clinicians may also participate in an audio-recorded phone interview over 20 minutes.
Interview
Participate in interview
Training
Receive training
Media Intervention
Utilize the CDB
Survey Administration
Ancillary studies
Clinics 15-17 (CDB)
Beginning 4 weeks before the practice begins use of the CDB, clinicians receive training on how to use the CDB and utilize the CDB over weeks 40-60. Clinicians may also participate in an audio-recorded phone interview over 20 minutes.
Interview
Participate in interview
Training
Receive training
Media Intervention
Utilize the CDB
Survey Administration
Ancillary studies
Clinics 18-20 (CDB)
Beginning 4 weeks before the practice begins use of the CDB, clinicians receive training on how to use the CDB and utilize the CDB over weeks 50-60. Clinicians may also participate in an audio-recorded phone interview over 20 minutes.
Interview
Participate in interview
Training
Receive training
Media Intervention
Utilize the CDB
Survey Administration
Ancillary studies
Clinics 21-25 (usual care)
Beginning 4 weeks before the practice begins use of the CDB, clinicians receive training on how to use the CDB and continue to provide breast cancer surgical care per their usual care. Clinicians may also participate in an audio-recorded phone interview over 20 minutes.
Interview
Participate in interview
Training
Receive training
Best Practice
Utilize usual care
Survey Administration
Ancillary studies
Interventions
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Decision Aid iCanDecide - ESE website
Utilize the iCanDecide - ESE website
Decision Aid iCanDecide - S website
Utilize the iCanDecide - S website
Therapeutic Conventional Surgery
Undergo surgery
Interview
Participate in interview
Training
Receive training
Media Intervention
Utilize the CDB
Best Practice
Utilize usual care
Survey Administration
Ancillary studies
Quality-of-Life Assessment
Ancillary studies
Eligibility Criteria
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Inclusion Criteria
* Women newly diagnosed with stage 0-III breast cancer. Although men are recommended to undergo surgery to treat breast cancer, male breast cancer is relatively rare and decision making for breast cancer surgery is quite different between men and women
* Planning breast surgery as a component of their definitive treatment within 5 weeks of registration
* Receives care from a clinician and at a practice that has consented to participate in the clinician dashboard practice-level intervention. Practices/clinicians will consent initially at the initiation of the study. Patients will then be identified and recruited in those practices. If a practice has more than one clinician doing breast surgery, patients will be recruited from those clinicians who consent (one or more). Patients of clinicians who have not consented will not be eligible
* Patients must be able to speak English or Spanish with the fluency required to have a direct discussion around treatment decision-making (i.e. without interpreter)
* Age 21-84 years
* CLINICIAN STAKEHOLDER (SURGEONS AND CLINIC STAFF) ELIGIBILITY CRITERIA
* Clinicians eligible for this study include: breast surgeons and their designee(s) (e.g., physician assistants, nurse practitioners, clinical nurse specialists, or nurses) that participate in the treatment decision-making process. At least one surgical oncologist at a practice must agree to participate and sign consent. S/he may then also identify a nurse, physician assistant (PA) or advanced practice provider (APP) with whom s/he works that is involved in the delivery of the care of the same patients to participate. Henceforth, in this protocol they will be referred to as "clinicians"
* Clinicians must agree to have their patients recruited for the entire time the study is open at their practice, which will include time periods in which the clinicians will and time periods in which they will not have access to the CDB
* INSTITUTION ELIGIBILITY:
* Practices that annually provide surgical care for over 100 patients newly diagnosed with breast cancer are eligible to participate in this study
* Eligible practices must have at least one surgical oncologist who agrees to participate in the study
Exclusion Criteria
* Patients with impaired decision-making capacity (such as with a diagnosis of dementia or memory loss) are not eligible for this study
* Practices currently enrolling to Alliance A231701CD are not eligible to participate in this study
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Sarah T. Hawley, PhD, MPH
Role: STUDY_CHAIR
University of Michigan School of Medicine and Public Health
Locations
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Kaiser Permanente-Vallejo
Vallejo, California, United States
Helen F Graham Cancer Center
Newark, Delaware, United States
Beebe Health Campus
Rehoboth Beach, Delaware, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, United States
Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii, United States
SSM Health Good Samaritan
Mount Vernon, Illinois, United States
Maine Medical Center- Scarborough Campus
Scarborough, Maine, United States
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, United States
West Michigan Cancer Center
Kalamazoo, Michigan, United States
Ascension Borgess Hospital
Kalamazoo, Michigan, United States
Northern Westchester Hospital
Mount Kisco, New York, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, United States
Montefiore Medical Center-Einstein Campus
The Bronx, New York, United States
Novant Health Breast Surgery - Greensboro
Greensboro, North Carolina, United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, United States
Sanford Broadway Medical Center
Fargo, North Dakota, United States
Adena Regional Medical Center
Chillicothe, Ohio, United States
Saint Ann's Hospital
Westerville, Ohio, United States
Genesis Healthcare System Cancer Care Center
Zanesville, Ohio, United States
Baptist Memorial Hospital for Women
Memphis, Tennessee, United States
ThedaCare Regional Cancer Center
Appleton, Wisconsin, United States
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, United States
Aurora Cancer Care-Grafton
Grafton, Wisconsin, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States
Aspirus Regional Cancer Center
Wausau, Wisconsin, United States
Ascension Medical Group Southeast Wisconsin - Mayfair Road
Wauwatosa, Wisconsin, United States
Aurora West Allis Medical Center
West Allis, Wisconsin, United States
Countries
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References
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Hawley ST, Kidwell K, Zahrieh D, McCarthy A, Wills R, Rankin A, Hofer T, Chow S, Jagsi R, Neuman H. Improving patient-centered communication in breast cancer: a study protocol for a multilevel intervention of a shared treatment deliberation system (SharES) within the NCI community oncology research program (NCORP) (Alliance A231901CD). Trials. 2023 Jan 6;24(1):16. doi: 10.1186/s13063-022-07048-4.
Other Identifiers
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