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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04549571
Recruitment Status : Not yet recruiting
First Posted : September 16, 2020
Last Update Posted : September 17, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Brief 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.

Condition or disease Intervention/treatment Phase
Anatomic Stage 0 Breast Cancer AJCC v8 Anatomic Stage I Breast Cancer AJCC v8 Anatomic Stage IA Breast Cancer AJCC v8 Anatomic Stage IB Breast Cancer AJCC v8 Anatomic Stage II Breast Cancer AJCC v8 Anatomic Stage IIA Breast Cancer AJCC v8 Anatomic Stage IIB Breast Cancer AJCC v8 Anatomic Stage III Breast Cancer AJCC v8 Anatomic Stage IIIA Breast Cancer AJCC v8 Anatomic Stage IIIB Breast Cancer AJCC v8 Anatomic Stage IIIC Breast Cancer AJCC v8 Prognostic Stage 0 Breast Cancer AJCC v8 Prognostic Stage I Breast Cancer AJCC v8 Prognostic Stage IA Breast Cancer AJCC v8 Prognostic Stage IB Breast Cancer AJCC v8 Prognostic Stage II Breast Cancer AJCC v8 Prognostic Stage IIA Breast Cancer AJCC v8 Prognostic Stage IIB Breast Cancer AJCC v8 Prognostic Stage III Breast Cancer AJCC v8 Prognostic Stage IIIA Breast Cancer AJCC v8 Prognostic Stage IIIB Breast Cancer AJCC v8 Prognostic Stage IIIC Breast Cancer AJCC v8 Other: Decision Aid iCanDecide - ESE website Other: Decision Aid iCanDecide - S website Procedure: Therapeutic Conventional Surgery Other: Interview Other: Training Other: Media Intervention Other: Best Practice Other: Survey Administration Other: Quality-of-Life Assessment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Care Provider)
Masking Description: The enhanced content of the ESE version iCanDecide-ESE is available to the patient, but does not populate differently into the CDB, allowing clinicians to remain blinded to the patient-level randomization arm; therefore, both the patient and the practice and clinicians will be blinded as to which arm the patient is assigned to. However, the surgical practices and their clinicians will know when they are using the CDB so the clinician level intervention will not be blinded.
Primary Purpose: Health Services Research
Official Title: Improving Patient-Centered Communication in Breast Cancer: A RCT of a Shared Decision Engagement System (SHADES)
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : January 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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: 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

Other: Quality-of-Life Assessment
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: Decision Aid iCanDecide - S website
Utilize the iCanDecide - S website

Procedure: Therapeutic Conventional Surgery
Undergo surgery

Other: Interview
Participate in interview

Other: Survey Administration
Ancillary studies

Other: Quality-of-Life Assessment
Ancillary studies

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: Training
Receive training

Other: Media Intervention
Utilize the CDB

Other: Survey Administration
Ancillary studies

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: Training
Receive training

Other: Media Intervention
Utilize the CDB

Other: Survey Administration
Ancillary studies

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: Training
Receive training

Other: Media Intervention
Utilize the CDB

Other: Survey Administration
Ancillary studies

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: Training
Receive training

Other: Media Intervention
Utilize the CDB

Other: Survey Administration
Ancillary studies

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: Training
Receive training

Other: Media Intervention
Utilize the CDB

Other: Survey Administration
Ancillary studies

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: Training
Receive training

Other: Media Intervention
Utilize the CDB

Other: Survey Administration
Ancillary studies

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: Training
Receive training

Other: Best Practice
Utilize usual care

Other: Survey Administration
Ancillary studies




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04549571


Contacts
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Contact: Sarah T. Hawley, PhD, MPH 734-936-8816 sarahawl@umich.edu

Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
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Study Chair: Sarah T. Hawley, PhD, MPH University of Michigan School of Medicine and Public Health
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Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT04549571    
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 )
First Posted: September 16, 2020    Key Record Dates
Last Update Posted: September 17, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Breast Carcinoma In Situ
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type