Evaluating Patient-Reported Outcomes and Wearable Data Among Individuals With Relapsed/Refractory Multiple Myeloma

Status: Recruiting
Location: See location...
Intervention Type: Device, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
United States
Washington
University of Washington
RECRUITING
Seattle
Contact Information
Primary
Kelly Brassil, PhD
dgxpharesearch@questdiagnostics.com
205-721-7542
Backup
Jennifer Loftis, DNP
dgxpharesearch@questdiagnostics.com
205-721-7542
Time Frame
Start Date: 2023-09-15
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 100
Treatments
Experimental: Single Arm Cohort Receiving Digital Health Coaching
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.
Related Therapeutic Areas
Sponsors
Collaborators: University of Washington, GlaxoSmithKline
Leads: Pack Health

This content was sourced from clinicaltrials.gov

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