A Study to Evaluate the My Hematology Oncology Patient Experience (MyHOPE™) For Multiple Myeloma (MM) Digital Care Network in Patients With MM

Sponsor

Celgene (Industry)

Overall Status

Terminated

CT.gov ID

NCT04730505

Collaborator

Amalgam Rx (Other)

Enrollment

Locations

Arms

4.5

Actual Duration (Months)

0.1

Patients Per Site

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Device: MyHOPE™ for Multiple Myeloma Device: MyHope HCP Portal	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

2 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

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

Actual Study Start Date :

Feb 4, 2021

Actual Primary Completion Date :

Jun 21, 2021

Actual Study Completion Date :

Jun 21, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patient App + HCP Portal (Cohort 1) Cohort 1 is to assess how patients will use the Patient App if connected in real time with the Healthcare professional (HCP) Portal	Device: MyHOPE™ for Multiple Myeloma 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. Device: MyHope HCP Portal 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.
Experimental: Patient App Alone (Cohort 2) 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	Device: MyHOPE™ for Multiple Myeloma 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.

Arm

Intervention/Treatment

Experimental: Patient App + HCP Portal (Cohort 1)

Cohort 1 is to assess how patients will use the Patient App if connected in real time with the Healthcare professional (HCP) Portal

Device: MyHOPE™ for Multiple Myeloma

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.

Device: MyHope HCP Portal

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.

Experimental: Patient App Alone (Cohort 2)

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

Device: MyHOPE™ for Multiple Myeloma

Outcome Measures

Primary Outcome Measures

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)
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
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
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
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
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)
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

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mitchell Cancer Center, University of South Alabama	Mobile	Alabama	United States	36604
2	Mayo Cliinic - Scottsdale	Scottsdale	Arizona	United States	85259
3	University of Arizona	Tucson	Arizona	United States	85724-507
4	James R Berenson MD Inc	West Hollywood	California	United States	90069
5	Mayo Clinic - Jacksonville	Jacksonville	Florida	United States	32224
6	Cancer Specialists of North Florida - Jacksonville	Jacksonville	Florida	United States	32258-5472
7	Winship Cancer Institute of Emory University	Atlanta	Georgia	United States	30322
8	Augusta University - Georgia Cancer Center	Augusta	Georgia	United States	30912
9	Innovation Clinical Research of the Pacific	Honolulu	Hawaii	United States	96813
10	Fort Wayne Medical Oncology and Hematology	Fort Wayne	Indiana	United States	46845
11	American Oncology Partner Maryland	Bethesda	Maryland	United States	20817
12	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
13	Dana Farber Cancer Institute	Boston	Massachusetts	United States	02215
14	Western Michigan Cancer Center	Kalamazoo	Michigan	United States	49007
15	Newland Medical Associates, PC	Southfield	Michigan	United States	48075
16	Mayo Clinic	Rochester	Minnesota	United States	55905
17	Hattiesburg Clinic	Hattiesburg	Mississippi	United States	39402
18	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029
19	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065
20	NY Cancer and Blood Specialists	Port Jefferson Station	New York	United States	11776
21	Rochester General Hospital - Lipson Cancer Institute	Rochester	New York	United States	14621
22	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	United States	27514
23	Duke University Medical Center	Durham	North Carolina	United States	27705
24	Cone Health Cancer Center	Greensboro	North Carolina	United States	27403
25	Wake Forest Baptist Health	Winston-Salem	North Carolina	United States	27157
26	Tri County Hematology Oncology	Canton	Ohio	United States	44718
27	Cleveland Clinic	Cleveland	Ohio	United States	44195
28	Oklahoma Cancer Specialists and Research Institute	Tulsa	Oklahoma	United States	74146
29	Jefferson Medical Oncology Associates	Philadelphia	Pennsylvania	United States	19107
30	Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States	19111
31	Cancer Care Associates of York	York	Pennsylvania	United States	17403
32	West Cancer Center	Germantown	Tennessee	United States	38138
33	University of Texas Southwestern Medical Center	Dallas	Texas	United States	75390
34	Community Cancer Trials of Utah	Ogden	Utah	United States	84405