Study of a 3-Month Digital Health Coaching Program Using Wearable Trackers for Adults With Relapsed or Refractory Multiple Myeloma
Led by Pack Health · Updated on 2025-04-20
100
Participants Needed
1
Research Sites
13 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are exploring a digital health coaching program designed for adults with relapsed or refractory multiple myeloma RR MM, a chronic cancer with no current cure. This study aims to better understand symptom burden, health self-management confidence, quality of life, financial impact, and how individuals experience their disease and treatment. It addresses gaps in knowledge about diverse patient experiences and the potential benefits of digital coaching in managing symptoms and wellbeing.
Participants will join a 3-month digital health coaching program that includes weekly phone calls with a health advisor and delivery of educational materials via text, email, or app up to four times a week. They will also receive a Fitbit device to wear daily, which tracks physical activity such as step counts and active minutes. This intervention seeks to support patients through regular symptom monitoring and coaching during their treatment journey.
During the study, participants will complete questionnaires and provide data from their Fitbit at baseline and at 30, 60, and 90 days after enrollment. Researchers will collect information on treatment experiences, quality of life, symptom management, and healthcare use. The main outcome is to assess the feasibility of this digital health coaching program after three months. The study will provide insights into managing RR MM through integrating patient-reported data, wearable technology, and clinical information.
CONDITIONS
Brief Title
PRO and Wearable Data Insights From Individuals With R/R Multiple Myeloma
Research Team
K
Kelly Brassil, PhD
J
Jennifer Loftis, DNP
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This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
Factors
Digital Health Coaching Program with Fitbit Activity Tracker
Usual Supportive Care (No Structured Digital Coaching or Fitbit Program)
What it is
A program that provides weekly phone coaching with a health advisor combined with delivery of wellness content (nutrition, exercise, emotional and financial health) and remote daily activity tracking through a Fitbit device.
Typical supportive care offered outside of clinical trials, which may include symptom management, general wellness advice on an ad-hoc basis, and routine oncology follow-up, but does not include structured digital health coaching sessions or systematic wearable activity monitoring.
Primary use
To assess feasibility and participant engagement with digital coaching and wearable monitoring as a supportive care strategy during second-line or later therapy for relapsed/refractory multiple myeloma.
To support physical and emotional wellbeing primarily through traditional in-person consultations, nurse or social worker follow-up, and ad-hoc lifestyle counseling as needed.
How it is delivered or performed
Participants receive weekly phone calls from a designated health advisor, regular wellness content electronically (up to four times weekly), and use a Fitbit tracker provided by the study for daily activity monitoring.
Supportive care is usually coordinated by the oncology care team during scheduled clinic visits, with lifestyle or wellbeing advice provided as needed. Routine use of apps or wearables is not standard.
Evidence status
Evidence for this intervention is still limited to early studies and ongoing trials in cancer populations, with feasibility and engagement as the primary outcomes under investigation.
Supportive care is supported by a broad evidence base as an important part of myeloma management, though structured e-health coaching is not a standard feature. Patient-reported outcome tracking is increasingly recognized as valuable even outside digital programs.
Important limitations
Long-term effects, patient-centered health outcomes, and overall survival impact are not yet established for digital coaching and wearable monitoring in people with multiple myeloma. Access requires smartphone/device ownership and sufficient English proficiency.
Routine supportive care may lack structured lifestyle coaching and real-time activity tracking, with potential gaps in wellbeing support and engagement outside clinic visits.
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
Age 18 or older
Confirmed diagnosis of multiple myeloma by primary physician; patients with concurrent AL amyloidosis are eligible
Starting at least the second line of multiple myeloma therapy at enrollment
Must have been treated with at least one proteasome inhibitor or immunomodulatory drug
You will not qualify if you...
Terminally ill individuals with expected survival of 6 months or less, or those receiving only comfort care
Previous participation in Pack Health digital health coaching
Insufficient English proficiency as assessed by physician
No personal smartphone or device for text, email, or app access
Serious or unstable medical, psychiatric, or other conditions interfering with safety or study compliance
Concurrent enrollment in another therapeutic study for relapsed or refractory multiple myeloma that prevents participation in this study
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) for eligibility assessment
Outpatient Treatment
Duration - 3 months
Participants engage in a 3-month digital health coaching program with weekly calls from a Health Advisor and receive supportive content via text, email, or app. Participants also wear a Fitbit device daily to capture physical activity data.
Assessments at baseline, 30, 60, and 90 days after consent
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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Published Research Related To This Trial
SOHO State of the Art Updates and Next Questions: T-Cell-Directed Immune Therapies for Multiple Myeloma: Chimeric Antigen Receptor-Modified T Cells and Bispecific T-Cell-Engaging Agents.
Deepu Madduri, Madhav V Dhodapkar, Sagar Lonial...
An international field study of the reliability and validity of a disease-specific questionnaire module (the QLQ-MY20) in assessing the quality of life of patients with multiple myeloma.
Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support.