Clinical trial NCT05956457: PRO and Wearable Data Insights From Individuals With R/R Multiple Myeloma
Official title: Evaluating Patient-Reported Outcomes and Wearable Data Among Individuals With Relapsed/Refractory Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Myeloma
Relapsed Hematologic Malignancy
Keywords: Digital health
Patient reported outcomes
Wearable Activity Trackers
Lead sponsor: Pack Health
Sponsor class: INDUSTRY
Collaborators: name: University of Washington
name: GlaxoSmithKline
First posted: 2023-07-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A single cohort of 100 individuals with relapsed/refractory multiple myeloma will be enrolled in the study, all of which will be enrolled in a digital health coaching program and receive a Fitbit device for activity tracking.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will evaluate the feasibility of a digital health coaching program for adults with relapsed or refractory multiple myeloma (R/R MM). One hundred adults with R/R MM will be enrolled at The University of Washington. Individuals who agree to take part in the study and sign an informed consent will be enrolled in a 3-month digital health coaching program. The program will provide weekly phone calls plus the delivery of learning materials to text or email. Questionnaires and data from a wrist-worn activity tracker will be collected. Outcomes include treatment and symptom experience, quality of life, financial burden, and how confident people feel to manage their health. Information about your condition and treatment will be collected, along with how often you use services like the emergency room, for care. This data will provide a better understanding of how a person experiences their R/R MM.

Detailed description: Multiple myeloma (MM) is a chronic malignancy with no current cure. Previously dependent on myeloablative chemotherapy and stem cell transplantation to induce prolonged remission, recent advances in targeted therapies are enhancing overall survival and extending the duration between treatments. Monoclonal antibodies, including CD38-directed monoclonal antibodies, combination immunotherapies, and T-cell therapies are among the many promising agents for treating relapsed or refractory (R/R) MM. This improvement in treatment outcomes is accompanied by significant risk for toxicities such a neutropenia and subsequent infections which themselves can be life-threatening. Several studies indicate a high symptom burden and poor health-related quality of life for individuals with multiple myeloma, with most of what is known from clinical trials of highly selective populations or qualitative studies conducted outside of the US among mostly white patients. These factors, coupled with the rapidly changing multiple myeloma treatment landscape, limits the generalizability to wider population as well as an understanding of MM's impact across the disease course. A more complete investigation of the symptom burden, health self-efficacy, and financial, physiologic, and psychosocial well-being among patients with multiple myeloma is urgently needed to provide a comprehensive view of the ways in which multiple myeloma and its treatments affects individuals' lives.

The purpose of this study is to explore the use of symptom monitoring and digital life coaching (DLC) to inform a more complete understanding of the impact of multiple myeloma on symptom burden, health self-efficacy, and financial, physiologic, and psychosocial well-being among a diverse U.S.-based, contemporary sample. The benefits of routine symptom monitoring have been demonstrated in recent studies, where overall survival increased among cancer patients who routinely monitored their symptoms. As the science related to symptom monitoring continues to evolve, exploring interventions to support both the assessment of and interventions related to disease and treatment-related sequelae it is important to identify how symptoms can best be monitored and managed. Studies to date have explored how symptom monitoring can be conducted for patients in the ambulatory setting, where patients do not receive around the clock assessment and management as they would in the hospital setting. In this context, digital or eHealth technologies are increasingly emerging as ways to promote health behaviors, and to monitor individuals with chronic health states, including cancer. An integrative review of 28 articles specifically evaluating eHealth interventions for patients with cancer identified 16 unique eHealth interventions, largely centered around educational support and decision aids. Telehealth counseling and navigation was found to be effective in supporting psychosocial needs in a small study (n=20) of underserved (defined by the authors as those who were primarily unemployed and uninsured) breast cancer patients. In a study of 1371 cancer patients, 71% reported using a mobile phone daily and 93% reported having internet access from home, of which 68% reported daily internet use, suggesting that internet-based technologies may be purposeful in the sharing of information with and coordination of care for cancer patients. Despite literature indicating its potential efficacy, few interventional studies have been published that evaluate digital health coaching and its relationship with self-efficacy and symptom management, specifically in R/R MM patients. As such, there is a gap in the literature on how digital health coaching might be used to support patients during cancer treatment and into survivorship.

Pack Health, LLC is an independent, patient engagement company that was established in 2014 with the mission of helping patients access the right care for their condition and develop the self-management skills to achieve better health and overall well-being. Pack Health offers a symptom management program involving both interpersonal interactions as well as e-modules for patients diagnosed with cancer to better manage pain, fatigue, depression, anxiety and navigate their care more effectively through digital health coaching and tools.

A recent pilot study at UCSF conducted in collaboration with Pack Health examined the impact of digital life coaching (DLC) on symptom outcomes for individuals with MM undergoing upfront stem cell transplantation. Outcomes suggest the efficacy of a coaching program for engagement up to day +100 post-transplant, with 73% (n=11) DLC engagement and 94% PRO completion. A randomized study of DLC versus usual care in individuals with MM undergoing upfront stem cell transplantation is underway. However, patients with R/R MM (where the disease has come back after prior lines of therapy such as transplantation) may have unique needs. An opportunity exists to explore how a digital health coaching platform might be used for symptom monitoring and coaching during treatment for R/R MM for whom the chronic nature of therapy may influence both needs and outcomes in relation to a DLC intervention.

This is a prospective study of patients with R/R MM to evaluate the feasibility and preliminary outcomes of DLC and its potential to augment existing standards of care for patient support. Patients enrolled in the program will be assigned to a health advisor who will act as an educator and accountability partner, supporting patients as they experience treatment for R/R MM. Throughout the engagement, patient reported outcomes (PROs) will be collected at multiple time points to assess the patient status and will be used to explore relationships between medical management, health related quality of life (HRQoL), and engagement in the program. Patients will be enrolled and will complete all assessments at baseline, 30, 60 and 90 days after consent. Findings from this study will establish feasibility of a DLC intervention for individuals with R/R MM and provide greater insight into their symptom burden, health self-efficacy, and financial, physiologic, and psychosocial well-being through the integration of patient reported, wearable and clinical data.

Eligibility criteria: Inclusion Criteria:

1. Age 18 or older
2. Confirmed diagnosis of MM as determined by participants' primary physicians at the study site. Patients with concurrent AL amyloidosis will be eligible.
3. Initiation of at least the second line of MM-directed therapy for multiple myeloma at time of study enrollment. Participants must have been exposed to at least one proteasome inhibitor (PI) and/or one immunomodulatory drug (IMiD).

Exclusion Criteria:

1. Individuals who are terminally ill, defined as individuals identified by their physician as likely having 6 months or less to live, or those individuals transitioned to comfort measures only (meaning only supportive care measures without curative focused treatment)
2. Individuals who have previously participated in Pack Health digital health coaching
3. Physician-assessed lack of sufficient English proficiency
4. Lack of ownership of a personal smartphone or device allowing for access to text, email or mobile application
5. Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with participant's safety, provision of informed consent, or compliance with study procedures
6. Concurrent enrollment on a therapeutic study in R/R MM that precludes simultaneous enrollment onto our non-therapeutic study

Primary outcomes:
measure: Feasibility of the Digital Health Coaching Intervention
timeFrame: At 3 months following the start of the coaching intervention
Secondary outcomes:
measure: Change in Cancer Behavior Inventory-Brief Form (CBI-B)
timeFrame: Change in baseline perception of treatment experience at 3 months
Other outcomes:
measure: Change in Center for Adherence Support Evaluation (CASE) Medication Adherence Index
timeFrame: Change in baseline perception of treatment experience at 3 months
measure: Change in Comprehensive Score for Financial Toxicity (COST) Instrument
timeFrame: Change in baseline perception of treatment experience at 3 months
measure: Change in Patient Health Questionnaire (PHQ) 4
timeFrame: Change in baseline perception of treatment experience at 3 months
measure: Change in Patient Reported Outcomes (PRO)-Common Terminology for Clinically Adverse Events (CTCAE) Blurry Vision Severity and Interference items
timeFrame: Change in baseline perception of treatment experience at 3 months
measure: Physical Activity
timeFrame: From date of enrollment up to 3 months
measure: Physical Activity
timeFrame: From date of enrollment up to 3 months
measure: Digital Engagement
timeFrame: From date of enrollment up to 3 months
measure: Digital Engagement
timeFrame: From date of enrollment up to 3 months
measure: Digital Engagement
timeFrame: From date of enrollment up to 3 months
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Rahul Banerjee, MD
role: PRINCIPAL_INVESTIGATOR
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