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

Part of paid clinical trials in Seattle, Washington.

Sponsor
Pack Health
Study ID
NCT05956457
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Sep 15, 2023
Status verified
Apr 2025
Primary completion
May 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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.

Primary Outcome Measure

Feasibility of the Digital Health Coaching Intervention [ Time Frame: At 3 months following the start of the coaching intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of WashingtonSeattleWashington98195
Trenton Grossfeld
[email protected]
206.606.1774
Rahul Banerjee, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Seattle, WA

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
University of Washington· Seattle, WA

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