Back to resultsA Study to Evaluate the My Hematology Oncology Patient Experience (MyHOPE™) For Multiple Myeloma (MM) Digital Care Network in Patients With MM (MyHOPE™)
Primary Purpose
Multiple Myeloma
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MyHOPE™ for Multiple Myeloma
MyHope HCP Portal
Sponsored by
About this trial
This is an interventional supportive care trial for Multiple Myeloma focused on measuring Digital Health, Multiple Myeloma, MYHOPE, Hematology Oncology
Eligibility Criteria
Inclusion Criteria:
- Patient is ≥ 18 years old with a diagnosis of Multiple Myeloma
- Patient must reside in the USA.
Patients within each of the following subgroups, at one of the following timepoints, will be eligible for entry:
- Newly-diagnosed multiple myeloma transplant-eligible
- Patients undergoing their first ASCT
- Newly-diagnosed multiple myeloma transplant-ineligible
- Relapsed and/or refractory.
Exclusion Criteria:
- Patient has a condition(s) that, in the opinion of the Investigator, would make participation infeasible such as inability to provide informed consent, illiteracy, or inability to speak, read, and write in English.
- Patient is on hospice.
- Patient is receiving or has received an investigational agent < 28 days prior to randomization or during this pilot study.
Sites / Locations
- Mitchell Cancer Center, University of South Alabama
- Mayo Cliinic - Scottsdale
- University of Arizona
- James R Berenson MD Inc
- Mayo Clinic - Jacksonville
- Cancer Specialists of North Florida - Jacksonville
- Winship Cancer Institute of Emory University
- Augusta University - Georgia Cancer Center
- Innovation Clinical Research of the Pacific
- Fort Wayne Medical Oncology and Hematology
- American Oncology Partner Maryland
- Massachusetts General Hospital
- Dana Farber Cancer Institute
- Western Michigan Cancer Center
- Newland Medical Associates, PC
- Mayo Clinic
- Hattiesburg Clinic
- Icahn School of Medicine at Mount Sinai
- Memorial Sloan Kettering Cancer Center
- NY Cancer and Blood Specialists
- Rochester General Hospital - Lipson Cancer Institute
- University of North Carolina at Chapel Hill
- Duke University Medical Center
- Cone Health Cancer Center
- Wake Forest Baptist Health
- Tri County Hematology Oncology
- Cleveland Clinic
- Oklahoma Cancer Specialists and Research Institute
- Jefferson Medical Oncology Associates
- Fox Chase Cancer Center
- Cancer Care Associates of York
- West Cancer Center
- University of Texas Southwestern Medical Center
- Community Cancer Trials of Utah
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Patient App + HCP Portal (Cohort 1)
Patient App Alone (Cohort 2)
Arm Description
Cohort 1 is to assess how patients will use the Patient App if connected in real time with the Healthcare professional (HCP) Portal
Cohort 2 is to assess how patients will use the Patient App where there is no connectivity to the Healthcare professional (HCP) Portal and thus no real-time data sharing with the HCP Portal
Outcomes
Primary Outcome Measures
Monthly eligibility and recruitment rates per month of patients with multiple myeloma
is defined as the number of patients with MM that satisfied entry criteria per study site/month)
User average weekly log-in rates over the duration of follow-up from patients with MM and HCPs
is defined as the number of times a user attempts to log in/week
Duration of follow-up
is defined as the mean, median, and range of time from each user's first login to his or her last login to the Patient App or to the HCP Portal
Patient-reported outcome completion rates
Is defined as the number of data points that are completed divided by the number of data points that could have been completed at each specified timepoint, relative to the enrollment date of each participant
Frequency of user access by feature and by month, relative to the enrollment date of each participant
Is defined as how often patients access various features of the app, per month relative to the enrollment date of each participant
Percentage of patients for whom the HCPs complete the 6-month assessments
is defined as number of patients for whom HCPs provided 6-month assessments [eg, disease response assessments] divided by the number of patients for whom HCPs provided baseline data)
Patient empowerment and self-efficacy measured by CASE-Cancer
The instrument consists of 3 subscales: understanding and participating in care, maintaining a positive attitude, and seeking and obtaining information. All items are scored on a range of 1 to 4 from strongly disagree to strongly agree, with higher score indicating better empowerment
Secondary Outcome Measures
Proportion of respondents scoring 4 or 5 on the Patient Platform Usability Survey or Healthcare Provider Platform Survey
is defined as the number of respondents giving a score of 4 or 5 to each of the questions in the Patient Platform Usability Survey divided by overall number of respondents for that question or number of respondents giving a score of 4 or 5 to each of the questions in the Healthcare Provider Platform Usability Survey divided by overall number of respondents for that question, respectively
Quality of life measured by Functional Assessment of Cancer Therapy-Multiple Myeloma (FACT-MM) total score
This scale addresses symptoms and functional limitations that are important to patients with MM. The items are scored on a 0 ("Not at all") to 4 ("Very much") response scale.
Full Information
NCT ID
NCT04730505
First Posted
January 26, 2021
Last Updated
August 5, 2021
Sponsor
Celgene
Collaborators
Amalgam Rx
1. Study Identification
Unique Protocol Identification Number
NCT04730505
Brief Title
A Study to Evaluate the My Hematology Oncology Patient Experience (MyHOPE™) For Multiple Myeloma (MM) Digital Care Network in Patients With MM
Acronym
MyHOPE™
Official Title
A Multi-center, Randomized, Pilot Trial to Evaluate the My Hematology Oncology Patient Experience (MYHOPE™) for Multiple Myeloma (MM) Digital Care Network in Patients With MM
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Terminated
Why Stopped
Study faced multiple challenges and its launch was heavily impacted by COVID, which in turn has significantly impacted the deployment and adoption goals for a digital technology pilot. These factors led to the difficult decision to close the study.
Study Start Date
February 4, 2021 (Actual)
Primary Completion Date
June 21, 2021 (Actual)
Study Completion Date
June 21, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene
Collaborators
Amalgam Rx
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
NDS-MM-004 is a multi-center, randomized, pilot trial to evaluate the MyHOPE for multiple myeloma (MM) Platform in patients with MM. The MyHOPE for MM Platform is a validated investigational device manufactured by Amalgam Rx, Inc. and designed to provide patients with a comprehensive set of tools and resources to support the patient throughout their overall experience with MM.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Digital Health, Multiple Myeloma, MYHOPE, Hematology Oncology
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patient App + HCP Portal (Cohort 1)
Arm Type
Experimental
Arm Description
Cohort 1 is to assess how patients will use the Patient App if connected in real time with the Healthcare professional (HCP) Portal
Arm Title
Patient App Alone (Cohort 2)
Arm Type
Experimental
Arm Description
Cohort 2 is to assess how patients will use the Patient App where there is no connectivity to the Healthcare professional (HCP) Portal and thus no real-time data sharing with the HCP Portal
Intervention Type
Device
Intervention Name(s)
MyHOPE™ for Multiple Myeloma
Intervention Description
The MyHOPE for MM Platform is designed to provide patients with tools and resources to support them in their overall experience with MM. Patients can share their data through a PDF or by showing their device to their care team at clinic visits.
Intervention Type
Device
Intervention Name(s)
MyHope HCP Portal
Intervention Description
Is designed to provide HCPs with the ability to view patient data and symptom notifications (Cohort 1 only) to provide support between clinic visits and to facilitate dialogue during clinic visits.
Primary Outcome Measure Information:
Title
Monthly eligibility and recruitment rates per month of patients with multiple myeloma
Description
is defined as the number of patients with MM that satisfied entry criteria per study site/month)
Time Frame
Up to 12 months
Title
User average weekly log-in rates over the duration of follow-up from patients with MM and HCPs
Description
is defined as the number of times a user attempts to log in/week
Time Frame
Up to 6 months
Title
Duration of follow-up
Description
is defined as the mean, median, and range of time from each user's first login to his or her last login to the Patient App or to the HCP Portal
Time Frame
Up to 6 months
Title
Patient-reported outcome completion rates
Description
Is defined as the number of data points that are completed divided by the number of data points that could have been completed at each specified timepoint, relative to the enrollment date of each participant
Time Frame
Up to 6 months
Title
Frequency of user access by feature and by month, relative to the enrollment date of each participant
Description
Is defined as how often patients access various features of the app, per month relative to the enrollment date of each participant
Time Frame
Up to 6 months
Title
Percentage of patients for whom the HCPs complete the 6-month assessments
Description
is defined as number of patients for whom HCPs provided 6-month assessments [eg, disease response assessments] divided by the number of patients for whom HCPs provided baseline data)
Time Frame
up to 18 months
Title
Patient empowerment and self-efficacy measured by CASE-Cancer
Description
The instrument consists of 3 subscales: understanding and participating in care, maintaining a positive attitude, and seeking and obtaining information. All items are scored on a range of 1 to 4 from strongly disagree to strongly agree, with higher score indicating better empowerment
Time Frame
Up to 6 months
Secondary Outcome Measure Information:
Title
Proportion of respondents scoring 4 or 5 on the Patient Platform Usability Survey or Healthcare Provider Platform Survey
Description
is defined as the number of respondents giving a score of 4 or 5 to each of the questions in the Patient Platform Usability Survey divided by overall number of respondents for that question or number of respondents giving a score of 4 or 5 to each of the questions in the Healthcare Provider Platform Usability Survey divided by overall number of respondents for that question, respectively
Time Frame
Up to 18 months
Title
Quality of life measured by Functional Assessment of Cancer Therapy-Multiple Myeloma (FACT-MM) total score
Description
This scale addresses symptoms and functional limitations that are important to patients with MM. The items are scored on a 0 ("Not at all") to 4 ("Very much") response scale.
Time Frame
Up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient is ≥ 18 years old with a diagnosis of Multiple Myeloma
Patient must reside in the USA.
Patients within each of the following subgroups, at one of the following timepoints, will be eligible for entry:
Newly-diagnosed multiple myeloma transplant-eligible
Patients undergoing their first ASCT
Newly-diagnosed multiple myeloma transplant-ineligible
Relapsed and/or refractory.
Exclusion Criteria:
Patient has a condition(s) that, in the opinion of the Investigator, would make participation infeasible such as inability to provide informed consent, illiteracy, or inability to speak, read, and write in English.
Patient is on hospice.
Patient is receiving or has received an investigational agent < 28 days prior to randomization or during this pilot study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Ludwig
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Mitchell Cancer Center, University of South Alabama
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
Facility Name
Mayo Cliinic - Scottsdale
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724-507
Country
United States
Facility Name
James R Berenson MD Inc
City
West Hollywood
State/Province
California
ZIP/Postal Code
90069
Country
United States
Facility Name
Mayo Clinic - Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Cancer Specialists of North Florida - Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32258-5472
Country
United States
Facility Name
Winship Cancer Institute of Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Augusta University - Georgia Cancer Center
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Innovation Clinical Research of the Pacific
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Fort Wayne Medical Oncology and Hematology
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845
Country
United States
Facility Name
American Oncology Partner Maryland
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Western Michigan Cancer Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Facility Name
Newland Medical Associates, PC
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48075
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Hattiesburg Clinic
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39402
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
NY Cancer and Blood Specialists
City
Port Jefferson Station
State/Province
New York
ZIP/Postal Code
11776
Country
United States
Facility Name
Rochester General Hospital - Lipson Cancer Institute
City
Rochester
State/Province
New York
ZIP/Postal Code
14621
Country
United States
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Cone Health Cancer Center
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Facility Name
Wake Forest Baptist Health
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Tri County Hematology Oncology
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Oklahoma Cancer Specialists and Research Institute
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74146
Country
United States
Facility Name
Jefferson Medical Oncology Associates
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Cancer Care Associates of York
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17403
Country
United States
Facility Name
West Cancer Center
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Community Cancer Trials of Utah
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Information relating to our policy on data sharing and the process for requesting data can be found at the following link:
https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
IPD Sharing Time Frame
See Plan Description
IPD Sharing Access Criteria
See Plan Description
IPD Sharing URL
https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
Learn more about this trial
A Study to Evaluate the My Hematology Oncology Patient Experience (MyHOPE™) For Multiple Myeloma (MM) Digital Care Network in Patients With MM
We'll reach out to this number within 24 hrs