A Study to Evaluate the My Hematology Oncology Patient Experience (MyHOPE™) For Multiple Myeloma (MM) Digital Care Network in Patients With MM
- Conditions
- Multiple Myeloma
- Interventions
- Device: MyHOPE™ for Multiple MyelomaDevice: MyHope HCP Portal
- Registration Number
- NCT04730505
- Lead Sponsor
- Celgene
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 2
-
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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Patient App + HCP Portal (Cohort 1) MyHope HCP Portal Cohort 1 is to assess how patients will use the Patient App if connected in real time with the Healthcare professional (HCP) Portal Patient App + HCP Portal (Cohort 1) MyHOPE™ for Multiple Myeloma Cohort 1 is to assess how patients will use the Patient App if connected in real time with the Healthcare professional (HCP) Portal Patient App Alone (Cohort 2) MyHOPE™ for Multiple Myeloma 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
- Primary Outcome Measures
Name Time Method Monthly eligibility and recruitment rates per month of patients with multiple myeloma Up to 12 months is defined as the number of patients with MM that satisfied entry criteria per study site/month)
Duration of follow-up Up to 6 months 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
Frequency of user access by feature and by month, relative to the enrollment date of each participant Up to 6 months Is defined as how often patients access various features of the app, per month relative to the enrollment date of each participant
Patient empowerment and self-efficacy measured by CASE-Cancer Up to 6 months 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
User average weekly log-in rates over the duration of follow-up from patients with MM and HCPs Up to 6 months is defined as the number of times a user attempts to log in/week
Patient-reported outcome completion rates Up to 6 months 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
Percentage of patients for whom the HCPs complete the 6-month assessments up to 18 months 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)
- Secondary Outcome Measures
Name Time Method Proportion of respondents scoring 4 or 5 on the Patient Platform Usability Survey or Healthcare Provider Platform Survey Up to 18 months 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 Up to 6 months 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.
Trial Locations
- Locations (34)
Winship Cancer Institute of Emory University
🇺🇸Atlanta, Georgia, United States
Jefferson Medical Oncology Associates
🇺🇸Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Western Michigan Cancer Center
🇺🇸Kalamazoo, Michigan, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Mitchell Cancer Center, University of South Alabama
🇺🇸Mobile, Alabama, United States
Mayo Cliinic - Scottsdale
🇺🇸Scottsdale, Arizona, United States
University of Arizona
🇺🇸Tucson, Arizona, United States
James R Berenson MD Inc
🇺🇸West Hollywood, California, United States
Mayo Clinic - Jacksonville
🇺🇸Jacksonville, Florida, United States
Cancer Specialists of North Florida - Jacksonville
🇺🇸Jacksonville, Florida, United States
Innovation Clinical Research of the Pacific
🇺🇸Honolulu, Hawaii, United States
Fort Wayne Medical Oncology and Hematology
🇺🇸Fort Wayne, Indiana, United States
Newland Medical Associates, PC
🇺🇸Southfield, Michigan, United States
Hattiesburg Clinic
🇺🇸Hattiesburg, Mississippi, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
NY Cancer and Blood Specialists
🇺🇸Port Jefferson Station, New York, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
Rochester General Hospital - Lipson Cancer Institute
🇺🇸Rochester, New York, United States
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Cone Health Cancer Center
🇺🇸Greensboro, North Carolina, United States
Tri County Hematology Oncology
🇺🇸Canton, Ohio, United States
Oklahoma Cancer Specialists and Research Institute
🇺🇸Tulsa, Oklahoma, United States
Cancer Care Associates of York
🇺🇸York, Pennsylvania, United States
Community Cancer Trials of Utah
🇺🇸Ogden, Utah, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
West Cancer Center
🇺🇸Germantown, Tennessee, United States
American Oncology Partner Maryland
🇺🇸Bethesda, Maryland, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Wake Forest Baptist Health
🇺🇸Winston-Salem, North Carolina, United States
Augusta University - Georgia Cancer Center
🇺🇸Augusta, Georgia, United States