Recruiting

Observational Study

Sponsor:

Pack Health

Code:

NCT05956457

Conditions

Multiple Myeloma

Relapsed Hematologic Malignancy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Digital Health Coaching Program

Fitbit

Study Details

Brief 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.

Conditions

Multiple Myeloma

Relapsed Hematologic Malignancy

Study ID

NCT05956457

Start date

Sep 15, 2023

Status verified date

Apr, 2025

Completion date

Aug 31, 2026

Anticipated

Primary completion date

May 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

Digital 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.

Fitbit

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.

Primary outcome measure

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

Central Contacts and Locations

Locations

University of Washington

Recruiting

Seattle, Washington, United States, 98195

Contacts

Principal Investigator:

Rahul Banerjee, MD

More Information

Sponsor

Pack Health

Last update posted

Apr 20, 2025

Last verified

Apr, 2025

Keywords

  • Digital health
  • Patient reported outcomes
  • Wearable Activity Trackers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Pack Health on 2025-04-20.