Breast Cancer Clinical Trial

Improving Patient-Centered Communication in Breast Cancer Through Patient and Provider Interventions

Summary

This trial studies the effectiveness of two interventions on patient reported outcomes of patient centered communication and decision making about breast cancer treatment. The first intervention consists of enhancements to an existing patient-facing breast cancer treatment decision tool called iCanDecide that supports the management of worry, distress, and anxiety as compared to an existing tool. The second intervention consists of a clinician dashboard that populates information after patients view either website regarding any ongoing issues or concerns.

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Full Description

The primary and key secondary objectives of the study:

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

PATIENT ELIGIBILITY
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 who are visually impaired are not eligible, as they must be able to access the study intervention on a website at home or in clinic and view the decision aid
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

Study is for people with:

Breast Cancer

Estimated Enrollment:

700

Study ID:

NCT04549571

Recruitment Status:

Recruiting

Sponsor:

Alliance for Clinical Trials in Oncology

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There are 27 Locations for this study

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Kaiser Permanente-Vallejo
Vallejo California, 94589, United States More Info
Site Public Contact
Contact
877-642-4691
[email protected]
Samantha A. Seaward
Principal Investigator
Helen F Graham Cancer Center
Newark Delaware, 19713, United States More Info
Site Public Contact
Contact
302-623-4450
[email protected]
Gregory A. Masters
Principal Investigator
Beebe Health Campus
Rehoboth Beach Delaware, 19971, United States More Info
Site Public Contact
Contact
302-645-3100
[email protected]
Gregory A. Masters
Principal Investigator
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah Georgia, 31405, United States More Info
Site Public Contact
Contact
912-819-5704
[email protected]
Catherine A. Ronaghan
Principal Investigator
Kaiser Permanente Moanalua Medical Center
Honolulu Hawaii, 96819, United States More Info
Site Public Contact
Contact
808-432-5195
[email protected]
Samantha A. Seaward
Principal Investigator
Good Samaritan Regional Health Center
Mount Vernon Illinois, 62864, United States More Info
Site Public Contact
Contact
618-242-4600
Jay W. Carlson
Principal Investigator
Maine Medical Center- Scarborough Campus
Scarborough Maine, 04074, United States More Info
Site Public Contact
Contact
207-396-8090
[email protected]
Paige Teller
Principal Investigator
Spectrum Health at Butterworth Campus
Grand Rapids Michigan, 49503, United States More Info
Site Public Contact
Contact
616-391-1230
[email protected]
Kathleen J. Yost
Principal Investigator
West Michigan Cancer Center
Kalamazoo Michigan, 49007, United States More Info
Site Public Contact
Contact
616-391-1230
[email protected]
Kathleen J. Yost
Principal Investigator
Borgess Medical Center
Kalamazoo Michigan, 49048, United States
Montefiore Medical Center-Einstein Campus
Bronx New York, 10461, United States More Info
Site Public Contact
Contact
718-379-6866
[email protected]
Sheldon M. Feldman
Principal Investigator
Northern Westchester Hospital
Mount Kisco New York, 10549, United States More Info
Site Public Contact
Contact
914-666-1366
[email protected]
Ranjana Chaterji
Principal Investigator
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York New York, 10032, United States More Info
Site Public Contact
Contact
212-305-6361
[email protected]
Bret Taback
Principal Investigator
Novant Health Breast Surgery - Greensboro
Greensboro North Carolina, 27403, United States More Info
Site Public Contact
Contact
336-660-5540
Judy A. Tjoe
Principal Investigator
Sanford Bismarck Medical Center
Bismarck North Dakota, 58501, United States
Sanford Broadway Medical Center
Fargo North Dakota, 58122, United States More Info
Site Public Contact
Contact
701-323-5760
[email protected]
Preston D. Steen
Principal Investigator
Adena Regional Medical Center
Chillicothe Ohio, 45601, United States More Info
Site Public Contact
Contact
877-779-7585
[email protected]
Timothy D. Moore
Principal Investigator
Saint Ann's Hospital
Westerville Ohio, 43081, United States More Info
Site Public Contact
Contact
614-234-5433
[email protected]
Timothy D. Moore
Principal Investigator
Genesis Healthcare System Cancer Care Center
Zanesville Ohio, 43701, United States More Info
Site Public Contact
Contact
740-454-5232
[email protected]
Timothy D. Moore
Principal Investigator
Baptist Memorial Hospital for Women
Memphis Tennessee, 38120, United States More Info
Site Public Contact
Contact
901-226-1366
[email protected]
Alyssa D. Throckmorton
Principal Investigator
ThedaCare Regional Cancer Center
Appleton Wisconsin, 54911, United States More Info
Site Public Contact
Contact
920-364-3605
[email protected]
Honnie R. Bermas
Principal Investigator
Marshfield Medical Center-EC Cancer Center
Eau Claire Wisconsin, 54701, United States More Info
Site Public Contact
Contact
800-782-8581
[email protected]
Sanjoy Saha
Principal Investigator
Aurora Cancer Care-Grafton
Grafton Wisconsin, 53024, United States More Info
Site Public Contact
Contact
414-302-2304
[email protected]
Joseph J. Weber
Principal Investigator
Gundersen Lutheran Medical Center
La Crosse Wisconsin, 54601, United States More Info
Site Public Contact
Contact
608-775-2385
[email protected]
Michael O. Ojelabi
Principal Investigator
Aspirus Regional Cancer Center
Wausau Wisconsin, 54401, United States More Info
Site Public Contact
Contact
877-405-6866
Cecilia Stroede
Principal Investigator
Ascension Medical Group Southeast Wisconsin - Mayfair Road
Wauwatosa Wisconsin, 53226, United States More Info
Site Public Contact
Contact
414-635-6420
[email protected]
Hanadi BuAli
Principal Investigator
Aurora West Allis Medical Center
West Allis Wisconsin, 53227, United States More Info
Site Public Contact
Contact
414-302-2304
[email protected]
Joseph J. Weber
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

700

Study ID:

NCT04549571

Recruitment Status:

Recruiting

Sponsor:


Alliance for Clinical Trials in Oncology

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