Overall Survival Results of a Trial Assessing Patient-Reported Outcomes for Symptom Monitoring During Routine Cancer Treatment.
Ethan Basch, Allison M Deal, Amylou C Dueck...
https://pubmed.ncbi.nlm.nih.gov/28586821Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID05956457
Evaluating Patient-Reported Outcomes and Wearable Data Among Individuals With Relapsed/Refractory Multiple Myeloma
Led by Pack Health · Updated on 2025-04-20
100
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
P
Pack Health
Lead Sponsor
U
University of Washington
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are exploring a digital health coaching program designed for adults with relapsed or refractory multiple myeloma (R/R 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 R/R 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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
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
Trial Site Locations
Total: 1 location
1
University of Washington
Seattle, Washington, United States, 98195
Actively Recruiting
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Research Team
K
Kelly Brassil, PhD
J
Jennifer Loftis, DNP
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
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.
K Cocks, D Cohen, F Wisløff...
https://pubmed.ncbi.nlm.nih.gov/17574838Managing relapsed myeloma: The views of patients, nurses and doctors.
Orlaith Cormican, Maura Dowling
https://pubmed.ncbi.nlm.nih.gov/27456375Measuring financial toxicity as a clinically relevant patient-reported outcome: The validation of the COmprehensive Score for financial Toxicity (COST).
Jonas A de Souza, Bonnie J Yap, Kristen Wroblewski...
https://pubmed.ncbi.nlm.nih.gov/27716900Internet-based technologies to improve cancer care coordination: current use and attitudes among cancer patients.
Anne Girault, Marie Ferrua, Benoît Lalloué...
https://pubmed.ncbi.nlm.nih.gov/25661828Recent advances in understanding multiple myeloma.
Parameswaran Hari
https://pubmed.ncbi.nlm.nih.gov/28633036Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support.
Paul A Harris, Robert Taylor, Robert Thielke...
https://pubmed.ncbi.nlm.nih.gov/18929686Assessing self-efficacy for coping with cancer: development and psychometric analysis of the brief version of the Cancer Behavior Inventory (CBI-B).
Carolyn A Heitzmann, Thomas V Merluzzi, Pascal Jean-Pierre...
https://pubmed.ncbi.nlm.nih.gov/20878830Patients' lived experience of myeloma.
Mary Kelly, Maura Dowling
https://pubmed.ncbi.nlm.nih.gov/21488448Health-related quality of life in older adult survivors of selected cancers: data from the SEER-MHOS linkage.
Erin E Kent, Anita Ambs, Sandra A Mitchell...
https://pubmed.ncbi.nlm.nih.gov/25369293