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

April 8, 2024 updated by: Alliance for Clinical Trials in Oncology

Improving Patient-Centered Communication in Breast Cancer: A RCT of a Shared Decision Engagement System (SHARES)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

700

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Vallejo, California, United States, 94589
        • Recruiting
        • Kaiser Permanente-Vallejo
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Samantha A. Seaward
    • Delaware
      • Newark, Delaware, United States, 19713
        • Recruiting
        • Helen F Graham Cancer Center
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
      • Rehoboth Beach, Delaware, United States, 19971
        • Recruiting
        • Beebe Health Campus
        • Contact:
        • Principal Investigator:
          • Gregory A. Masters
    • Georgia
      • Savannah, Georgia, United States, 31405
        • Recruiting
        • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
        • Contact:
        • Principal Investigator:
          • Catherine A. Ronaghan
    • Hawaii
      • Honolulu, Hawaii, United States, 96819
        • Recruiting
        • Kaiser Permanente Moanalua Medical Center
        • Contact:
        • Principal Investigator:
          • Samantha A. Seaward
    • Illinois
      • Mount Vernon, Illinois, United States, 62864
        • Active, not recruiting
        • Good Samaritan Regional Health Center
    • Maine
      • Scarborough, Maine, United States, 04074
        • Recruiting
        • Maine Medical Center- Scarborough Campus
        • Principal Investigator:
          • Paige Teller
        • Contact:
          • Site Public Contact
          • Phone Number: 207-396-8090
          • Email: wrighd@mmc.org
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Spectrum Health at Butterworth Campus
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Kalamazoo, Michigan, United States, 49007
        • Recruiting
        • West Michigan Cancer Center
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Kalamazoo, Michigan, United States, 49048
        • Suspended
        • Borgess Medical Center
    • New York
      • Bronx, New York, United States, 10461
        • Recruiting
        • Montefiore Medical Center-Einstein Campus
        • Principal Investigator:
          • Sheldon M. Feldman
        • Contact:
      • Mount Kisco, New York, United States, 10549
        • Recruiting
        • Northern Westchester Hospital
        • Principal Investigator:
          • Ranjana Chaterji
        • Contact:
      • New York, New York, United States, 10032
        • Recruiting
        • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
        • Principal Investigator:
          • Bret Taback
        • Contact:
    • North Carolina
      • Greensboro, North Carolina, United States, 27403
        • Suspended
        • Novant Health Breast Surgery - Greensboro
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • Suspended
        • Sanford Bismarck Medical Center
      • Fargo, North Dakota, United States, 58122
    • Ohio
      • Chillicothe, Ohio, United States, 45601
        • Recruiting
        • Adena Regional Medical Center
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Westerville, Ohio, United States, 43081
        • Recruiting
        • Saint Ann's Hospital
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Zanesville, Ohio, United States, 43701
        • Recruiting
        • Genesis Healthcare System Cancer Care Center
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Recruiting
        • Baptist Memorial Hospital for Women
        • Principal Investigator:
          • Alyssa D. Throckmorton
        • Contact:
    • Wisconsin
      • Appleton, Wisconsin, United States, 54911
        • Recruiting
        • ThedaCare Regional Cancer Center
        • Principal Investigator:
          • Honnie R. Bermas
        • Contact:
      • Eau Claire, Wisconsin, United States, 54701
      • Grafton, Wisconsin, United States, 53024
        • Recruiting
        • Aurora Cancer Care-Grafton
        • Principal Investigator:
          • Joseph J. Weber
        • Contact:
      • La Crosse, Wisconsin, United States, 54601
        • Recruiting
        • Gundersen Lutheran Medical Center
        • Contact:
        • Principal Investigator:
          • Michael O. Ojelabi
      • Wausau, Wisconsin, United States, 54401
        • Recruiting
        • Aspirus Regional Cancer Center
        • Principal Investigator:
          • Andrew J. Huang
        • Contact:
          • Site Public Contact
          • Phone Number: 877-405-6866
      • Wauwatosa, Wisconsin, United States, 53226
        • Recruiting
        • Ascension Medical Group Southeast Wisconsin - Mayfair Road
        • Principal Investigator:
          • Hanadi BuAli
        • Contact:
      • West Allis, Wisconsin, United States, 53227
        • Recruiting
        • Aurora West Allis Medical Center
        • Principal Investigator:
          • Joseph J. Weber
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Quality-of-Life Assessment
Ancillary studies
Other: Decision Aid iCanDecide - ESE website
Utilize the iCanDecide - ESE website
Procedure: Therapeutic Conventional Surgery
Undergo surgery
Other: Interview
Participate in interview
Other: Survey Administration
Ancillary studies
Active Comparator: 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.
Other: Quality-of-Life Assessment
Ancillary studies
Procedure: Therapeutic Conventional Surgery
Undergo surgery
Other: Interview
Participate in interview
Other: Survey Administration
Ancillary studies
Other: Decision Aid iCanDecide - S website
Utilize the iCanDecide - S website
Experimental: 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.
Other: Interview
Participate in interview
Other: Survey Administration
Ancillary studies
Other: Training
Receive training
Other: Media Intervention
Utilize the CDB
Experimental: 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.
Other: Interview
Participate in interview
Other: Survey Administration
Ancillary studies
Other: Training
Receive training
Other: Media Intervention
Utilize the CDB
Experimental: 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.
Other: Interview
Participate in interview
Other: Survey Administration
Ancillary studies
Other: Training
Receive training
Other: Media Intervention
Utilize the CDB
Experimental: 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.
Other: Interview
Participate in interview
Other: Survey Administration
Ancillary studies
Other: Training
Receive training
Other: Media Intervention
Utilize the CDB
Experimental: 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.
Other: Interview
Participate in interview
Other: Survey Administration
Ancillary studies
Other: Training
Receive training
Other: Media Intervention
Utilize the CDB
Experimental: 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.
Other: Interview
Participate in interview
Other: Survey Administration
Ancillary studies
Other: Training
Receive training
Other: Media Intervention
Utilize the CDB
Active Comparator: 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.
Other: Interview
Participate in interview
Other: Survey Administration
Ancillary studies
Other: Training
Receive training
Other: Best Practice
Utilize usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient knowledge about risks and benefits of local regional treatment
Time Frame: At 4-5 weeks post patient randomization
Will be defined as the percentage of correct answers (range: 0-100%) from a 5-item scale previously developed and pilot tested where higher percentages indicate increased knowledge of treatment risks and benefits of local regional treatment. Because the interventions are fully crossed (with intervention and control patients within both intervention and control practices for every time period), the intervention effect of iCanDecide-E and the intervention effect of the clinician dashboard (CDB) will be obtained from a single linear mixed-effects model for the continuous primary outcome measure patient knowledge.
At 4-5 weeks post patient randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient self-efficacy in dealing with breast cancer
Time Frame: At 4-5 weeks post patient randomization
Will be defined as the composite score obtained from the 11-item (each rated on a 5-point Likert scale: "strongly disagree" to "strongly agree") validated scale designed to assess breast cancer patients' overall feelings of control of their cancer and worry about their cancer (range: 11 to 55); higher scores indicate increased self-efficacy. Because the interventions are fully crossed (with intervention and control patients within both intervention and control practices for every time period), the intervention effect of iCanDecide-E and the intervention effect of the clinician dashboard (CDB) will be obtained from a single linear mixed-effects model for the continuous secondary outcome measure patient self-efficacy.
At 4-5 weeks post patient randomization
Patient cancer worry
Time Frame: At 4-5 weeks post patient randomization
Will be defined as the total score obtained from the 8-item (each rated on a 4-point Likert scale: "never" to "almost always") validated Cancer Worry Scale assessing the degree of cancer-related worry (range: 8 to 40); higher scores indicate more frequent worries about cancer. Because the interventions are fully crossed (with intervention and control patients within both intervention and control practices for every time period), the intervention effect of iCanDecide-E and the intervention effect of the clinician dashboard (CDB) will be obtained from a single linear mixed-effects model for the continuous secondary outcome measure patient cancer worry.
At 4-5 weeks post patient randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alliance for Clinical Trials in Oncology

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Sarah T. Hawley, PhD, MPH, University of Michigan School of Medicine and Public Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 16, 2021

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

September 9, 2020

First Submitted That Met QC Criteria

September 9, 2020

First Posted (Actual)

September 16, 2020

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A231901CD
  • NCI-2020-06176 (Registry Identifier: NCI Clinical Trial Reporting Program)
  • UG1CA189823 (U.S. NIH Grant/Contract)
  • R01CA237046 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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