Digital health coaching for adults with relapsed multiple myeloma
Evaluating Patient-Reported Outcomes and Wearable Data Among Individuals With Relapsed/Refractory Multiple Myeloma
NA · Pack Health · NCT05956457
This study is testing a digital health coaching program for adults with relapsed multiple myeloma to see if it can help improve their quality of life and health management.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Pack Health (industry) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Seattle, Washington) |
| Trial ID | NCT05956457 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility of a digital health coaching program for adults diagnosed with relapsed or refractory multiple myeloma. One hundred participants will engage in a 3-month program that includes weekly phone calls and the delivery of educational materials via text or email. Data will be collected through questionnaires and a wrist-worn activity tracker to assess treatment experiences, symptom burden, quality of life, and health management confidence. The goal is to gain insights into how multiple myeloma affects patients' lives and to improve their overall well-being.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older with a confirmed diagnosis of multiple myeloma who are starting their second line of therapy.
Not a fit: Patients who are terminally ill or have previously participated in similar digital health coaching programs may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could enhance the quality of life and health management for patients with relapsed multiple myeloma.
How similar studies have performed: While there is growing interest in digital health interventions for chronic conditions, this specific approach in relapsed multiple myeloma is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18 or older 2. Confirmed diagnosis of MM as determined by participants' primary physicians at the study site. Patients with concurrent AL amyloidosis will be eligible. 3. 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). Exclusion Criteria: 1. Individuals who are terminally ill, defined as individuals identified by their physician as likely having 6 months or less to live, or those individuals transitioned to comfort measures only (meaning only supportive care measures without curative focused treatment) 2. Individuals who have previously participated in Pack Health digital health coaching 3. Physician-assessed lack of sufficient English proficiency 4. Lack of ownership of a personal smartphone or device allowing for access to text, email or mobile application 5. Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with participant's safety, provision of informed consent, or compliance with study procedures 6. Concurrent enrollment on a therapeutic study in R/R MM that precludes simultaneous enrollment onto our non-therapeutic study
Where this trial is running
Seattle, Washington
- University of Washington — Seattle, Washington, United States (RECRUITING)
Study contacts
- Principal investigator: Rahul Banerjee, MD — University of Washington
- Study coordinator: Kelly Brassil, PhD
- Email: dgxpharesearch@questdiagnostics.com
- Phone: 205-721-7542
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Multiple Myeloma, Relapsed Hematologic Malignancy, Digital health, Patient reported outcomes, Wearable Activity Trackers