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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
2
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.
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.
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)
Time frame: Up to 12 months
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
Time frame: Up to 6 months
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
Time frame: Up to 6 months
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
Time frame: Up to 6 months
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
Time frame: Up to 6 months
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)
Time frame: up to 18 months
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
Augusta University - Georgia Cancer Center
Augusta, Georgia, United States
Innovation Clinical Research of the Pacific
Honolulu, Hawaii, United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States
...and 24 more locations
Time frame: Up to 6 months
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
Time frame: Up to 18 months
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.
Time frame: Up to 6 months