RecruitingNot ApplicableNCT05956457

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

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

Sponsor

Pack Health

Enrollment

100 participants

Start Date

Sep 15, 2023

Study Type

INTERVENTIONAL

Conditions

Multiple Myeloma Relapsed Hematologic Malignancy

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This observational study is collecting data from wearable devices and patient-reported outcomes (surveys about how you feel) to better understand the day-to-day experience of people with relapsed or refractory multiple myeloma (a blood cancer). The information gathered will help researchers design better future treatments and measure what matters most to patients. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of multiple myeloma - You have started at least your second line of treatment for myeloma - You own a personal smartphone or device that supports texting, email, or apps **You may NOT be eligible if...** - You are terminally ill with less than 6 months to live, or in comfort/hospice care only - You have previously participated in Pack Health digital health coaching - You lack sufficient English proficiency (as assessed by your doctor) - You have an unstable medical or psychiatric condition that would interfere with study participation - You are already enrolled in a therapeutic clinical trial for myeloma that prohibits co-enrollment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALDigital 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.

DEVICEFitbit

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.