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Clinical Trials in the USA / NCT05956457
Recruiting Not applicable

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

NCT05956457 · tracked via the Priya Life Science USA tracker
Sponsor
Pack Health
Phase
Not applicable
Started
2023-09-15
Last updated
2025-04-20

Condition(s) studied

Multiple MyelomaRelapsed Hematologic Malignancy

Investigational drug(s) / intervention(s)

Digital Health Coaching ProgramFitbit

Digital Health Coaching Program: 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.

Fitbit: 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 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)

  • Feasibility of the Digital Health Coaching Intervention — At 3 months following the start of the 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

Trial sites (1)

FacilityCityRegionStatus
University of Washington Seattle Washington Recruiting

More Pack Health trials in the USA

Comprehensive Outcomes for After Cancer Health Recruiting
Real World Insights During Treatment for Relapsed/Refractory Multiple Myeloma with Isatuximab Recruiting

Other trials for the same condition

PRospective Multiple Myeloma Impact Study Active, not recruiting
A Phase 1 Study of Ruxolitinib, Steroids and Lenalidomide for Relapsed/Refractory Multiple Myeloma (RRMM) Patients Recruiting
IDP-023 as a Single Agent and in Combination With Antibody Therapies in Patients With Advanced Hematologic Cancers Recruiting
A Study Comparing Anitocabtagene Autoleucel to Standard of Care Therapy in Participants With Relapsed/ Refractory Multiple Myeloma Active, not recruiting
A Study of an MMSET Inhibitor in Patients With Relapsed and Refractory Multiple Myeloma Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05956457 on ClinicalTrials.gov ↗ ← All trials in the USA