Real World Insights During Treatment for Relapsed/Refractory Multiple Myeloma with Isatuximab

Part of paid clinical trials in Houston, Texas.

Sponsor
Pack Health
Study ID
NCT05053607
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Digital Health Coaching Program — BEHAVIORAL
    consisting of weekly calls and delivery of evidence-based content across health and wellness domains (e.g. nutrition, exercise, physical, emotional and financial health) up to 4 times weekly via text, email or mobile application.
  • Fitbit — DEVICE
    A wrist-worn activity tracker allowing for the capture of physical activity, including but not limited to step-count and minutes of activity, to be captured daily.

Study Details

This descriptive study aims to evaluate the experience of adults with relapsed or refractory multiple myeloma receiving standard of care isatuximab-irfc through collection of quantitative, qualitative and wearable data. Fifty adults with relapsed or refractory multiple myeloma receiving standard of care isatuximab-irfc will be enrolled across 2 sites, The University of California San Francisco and The University of Texas MD Anderson Cancer Center. Consented participants will be enrolled in a 3-month digital health coaching program through which electronic patient reported outcomes and wearable activity data will be collected. Outcomes include treatment experience, quality of life, financial toxicity, treatment adherence, symptom burden and health self-efficacy. These will be captured by patient reported outcome measures including the Patient's Qualitative Assessment of Treatment- Real World (PQAT-RW), Patient Global Impression of Change/Severity (PGIC/S), European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30), Quality of Life Questionnaire Multiple Myeloma (QLQ-MY20), and the European QoL-5 Dimensions (EQ5D), Cancer Behavior Inventory-Brief Form (CBI-B), Center for Adherence Support Evaluation (CASE) Medication Adherence Index, Comprehensive Score for Financial Toxicity (COST) Instrument. Clinical data, including treatment history, healthcare utilization, and co-morbidities, as well as demographic data will be collected via the electronic health record from each clinical site. This data will be complemented by qualitative data from a selected cohort of study participants with a focus on treatment experience ranging from infusion burden, toxicity management, to overall quality of life. Evaluation of this data in combination will be used to better understand the treatment experience of individuals on standard of care isatuximab-irfc specifically, and with relapsed or refractory multiple myeloma generally, contributing to an existing gap in the literature regarding patient reported outcomes from diverse data sources. Outcomes will be analyzed with attention to the relationship between social determinants of health, including race, ethnicity, and geographic location, and treatment experience as reflected in both the qualitative and quantitative data.

Key Dates

Start date
Jun 17, 2022
Status verified
Dec 2024
Primary completion
Aug 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Other: 1. Single Arm Cohort Receiving Digital Health Coaching
    All study participants will be enrolled in a 3-month digital health coaching program. They will also receive a Fitbit device to be worn daily for the capture of physical activity data. Participants have the option to participate in a one time interview about their treatment experience.

Primary Outcome Measure

Change in Patient's Qualitative Assessment of Treatment Real World version (PQAT-RW) [ Time Frame: Change in baseline perception of treatment experience at 3 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
The University of Texas MD Anderson Cancer CenterHoustonTexas77074-
University of WashingtonSeattleWashington98109
Trenton Grossfeld, BS
[email protected]
206-606-1774
Rahul Banerjee, MD

Find similar trials in Houston, TX

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
The University of Texas MD Anderson Cancer Center· Houston, TXUniversity of Washington· Seattle, WA

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