PRO and Wearable Data Insights From Individuals With R/R Multiple Myeloma

NCT05956457 | Recruiting

• 1 other identifier: STUDY00016359
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma; Relapsed Hematologic Malignancy

Keywords

Digital health; Patient reported outcomes; Wearable Activity Trackers

Outcome Measures

Primary Outcomes (1)

• Feasibility of the Digital Health Coaching Intervention

  A retention rate greater than or equal to 70%. Retention is defined as individuals who agree to participate in the digital health coaching 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

  At 3 months following the start of the coaching intervention

Secondary Outcomes (1)

• Change in Cancer Behavior Inventory-Brief Form (CBI-B)

  Change in baseline perception of treatment experience at 3 months

Other Outcomes (9)

• Change in Center for Adherence Support Evaluation (CASE) Medication Adherence Index

  Change in baseline perception of treatment experience at 3 months

• Change in Comprehensive Score for Financial Toxicity (COST) Instrument

  Change in baseline perception of treatment experience at 3 months

• Change in Patient Health Questionnaire (PHQ) 4

  Change in baseline perception of treatment experience at 3 months

Study Arms (1)

Single Arm Cohort Receiving Digital Health Coaching

EXPERIMENTAL

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.

Behavioral: Digital Health Coaching Program; Device: Fitbit

Interventions

Digital Health Coaching Program BEHAVIORAL

Digital health intervention consisting of weekly calls from a Health Advisor to a participant, accompanied by 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.

Also known as: Pack Health Digital Health Coaching

Single Arm Cohort Receiving Digital Health Coaching

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.

Also known as: Charge 5

Single Arm Cohort Receiving Digital Health Coaching

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older
• Confirmed diagnosis of MM as determined by participants' primary physicians at the study site. Patients with concurrent AL amyloidosis will be eligible.
• 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).

You may not qualify if:

• 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)
• Individuals who have previously participated in Pack Health digital health coaching
• Physician-assessed lack of sufficient English proficiency
• Lack of ownership of a personal smartphone or device allowing for access to text, email or mobile application
• 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
• Concurrent enrollment on a therapeutic study in R/R MM that precludes simultaneous enrollment onto our non-therapeutic study

Sponsors & Collaborators

• Pack Health: lead
• University of Washington: collaborator
• GlaxoSmithKline: collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

RECRUITING

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MeSH Terms

Conditions

Multiple Myeloma; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Neoplasms by Site

Study Officials

• Rahul Banerjee, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelly Brassil, PhD

CONTACT

205-721-7542; dgxpharesearch@questdiagnostics.com

Jennifer Loftis, DNP

CONTACT

205-721-7542; dgxpharesearch@questdiagnostics.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 28, 2023
• First Posted: July 21, 2023
• Study Start: September 15, 2023
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: April 20, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)