Evaluating Patient-Reported Outcomes and Wearable Data Among Individuals with Relapsed/Refractory Multiple Myeloma
Authors: Banerjee Rahul , Brassil Kelly , Grossfeld Trenton , Barr Austin , Cowan Andrew J. 
Published: December 2023

Background: Digital life coaching (DLC) pairs patients with a certified health coach to identify and achieve wellness-related goals through phone calls and text messages. DLC has been shown to improve physical quality of life in a recent randomized trial of patients with multiple myeloma (MM) undergoing upfront transplantation (Banerjee, BMT 2023). However, transplantation is an acute life disruption that may not necessarily reflect long-term wellness; this is particularly true for patients living with relapsed/refractory (R/R )MM, for which symptom burden and uncertainty may be chronically higher. As such, a new study (clinicaltrials.gov ID: NCT05956457) is under way to explore the feasibility and outcomes of DLC with integrated symptom monitoring (via a wearable activity tracker) to inform a more complete understanding of the patient experience with R/R MM. Endpoints from this study will include symptom burden, health self-efficacy, and financial, physiologic, and psychosocial well-being, and if and how DLC may be used to support this population.

Study Design and Methods: For this prospective, non-randomized, quasi-experimental study at the University of Washington, up to 100 individuals will be enrolled. Individuals must meet the following Inclusion criteria: English speaking; aged 18 years and older, R/R MM diagnosis; initiated at least the second line of therapy for MM at time of study enrollment and must have been exposed to at least one proteasome inhibitor (PI) and/or one immunomodulatory drug (IMiD). Individuals will be excluded from participation if they meet any of following criteria: anticipated to have 6 months or less to live, have a serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with participant safety, provision of informed consent, or compliance with study procedures; and those who do not own or have access to a personal smartphone or device allowing for access to text or email

Consented individuals will be enrolled in a 3-month DLC coaching program, consisting of weekly calls and up to 4 digital nudges, delivery of content via text or email, each week. The evidence-based coaching curriculum focuses on supporting patient self-management of symptoms; physical, mental, financial, social and sexual health; and nutrition, exercise, and sleep. Patient-reported outcomes (PROs) will be collected at baseline and monthly for 3 months to track progress during both coaching and treatment, and to provide insights into the experience and well-being of participants. PROs include quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-30 & Quality of Life Questionnaire Multiple Myeloma-20); health self-efficacy (measured with the Cancer Behavior Inventory- Brief); anxiety and depression (Patient Health Questionnaire-4); financial toxicity (Comprehensive Score for Financial Toxicity); and medication adherence (CASE Medication Adherence Index). Physical activity will be captured via wrist-worn activity tracker provided to participants.

Descriptive analysis will be conducted for this study. Feasibility for this study is defined as a retention rate greater than or equal to 70%. Retention is defined as individuals who agree to participate in the DLC program and complete the 3 months of engagement post-enrollment. Engagement is defined as the completion of 1 nudge (call, text, or email) per module out of 5 nudge opportunities. Summary statistics, such as frequencies, percentages, means, standard deviations, and ranges, will be used to describe patient demographic and clinical characteristics of the study population. Summary statistics will also be used to describe PRO by assessment time. We will also assess the additional PRO trends over time using linear mixed models (LMMs). Additional models will be created to assess intervention effect while controlling for possible confounding covariates, and the relationship between self-efficacy and other PROs.

Implications: Results of this study are anticipated to elucidate (1) if and how DLC may be used to support individuals with R/R MM and (2) clinical and PRO outcomes, including both survey and wearable data, for individuals with R/R MM in a DLC program.