NCT05956457Recruiting
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
Source: ClinicalTrials.gov · Last updated 20 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 28 Jun 2023
- Start date
- 15 Sept 2023
- Primary completion date
- 31 May 2026
- Lead sponsor
- Pack Health
- Diseases
- Multiple myeloma
- NCT number
- NCT05956457
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 15 Sept 2023 to the primary completion date, 31 May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Individuals who have previously participated in Pack Health digital health coaching
- Concurrent enrollment on a therapeutic study in R/R MM that precludes simultaneous enrollment onto our non-therapeutic study
Other illness
- 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
Other
- 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)
- Physician-assessed lack of sufficient English proficiency
- Lack of ownership of a personal smartphone or device allowing for access to text, email or mobile application
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Washington Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.