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NCT04589286 · ClinicalTrials.gov registry record · NA
Randomized Study of Digital Life Coaching in Myeloma Patients Undergoing Transplantation
A NA study of Multiple Myeloma and Stem Cell Transplant, sponsored by University of California, San Francisco.
- Completed
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT04589286: Completed NA study of Multiple Myeloma and Stem Cell Transplant, sponsored by University of California, San Francisco.
NCT04589286 is a NA study of Multiple Myeloma and Stem Cell Transplant that has completed, run by University of California, San Francisco. The registered enrollment target is 60 participants, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04589286, a NA study of Multiple Myeloma and Stem Cell Transplant, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
Autologous stem cell transplantation (SCT) is the standard of care for fit multiple myeloma (MM) patients; however, the first 100 days after SCT are marked by extensive life disruptions. We have found a 56% relative increase in the use of high-risk benzodiazepine and Z-class (B/Z) drugs for anxiety and insomnia among MM patients during this period. Digital life coaching (DLC), whereby trained coaches work longitudinally with patients through phone calls and text messages to accomplish personal goals, may be able to target anxiety and insomnia in a more integrative manner. This study will investigate whether peri-SCT DLC can lower B/Z usage and improve patient-reported well-being.
Primary Outcome
Proportions of patients with \>=1 B/Z prescription versus \<1 B/Z prescriptions will be compared between arms using chi-square analyses. Participants will be stratified on B/Z usage over time into 3 groups arms based on B/Z-naïve status (i.e., no B/Z usage at time of study enrollment), baseline psychosocial distress, defined as an National Comprehensive Caner Network (NCCN) Distress Thermometer (DT) score of 4 or higher, and baseline insomnia, defined as a Patient-Reported Outcomes Measurement I
Conditions Studied
Interventions
- BEHAVIORAL Pack Health's Digital Life Coaching (DLC)
- OTHER Electronic Handouts
Study Locations (1)
California
- University of California, San Francisco - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2020-12-29 |
| Est. Completion | 2023-06-30 |
| Phase | NA |
What the finished NCT04589286 record still lists
NCT04589286 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (89% lower).
The record links to 2 conditions, with Multiple Myeloma appearing as the primary indexed condition, and to 2 interventions - of which Pack Health's Digital Life Coaching (DLC) is the first listed.
NCT04589286 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04589286 about?
NCT04589286 is a clinical study titled "Randomized Study of Digital Life Coaching in Myeloma Patients Undergoing Transplantation". Autologous stem cell transplantation (SCT) is the standard of care for fit multiple myeloma (MM) patients; however, the first 100 days after SCT are marked by extensive life disruptions. We have found a 56% relative increase in the use of high-risk benzodiazepine and Z-class (B/Z) drugs for anxiety ...
What is the current status of trial NCT04589286?
This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2020-12-29. Estimated completion is 2023-06-30.
What conditions does trial NCT04589286 study?
This clinical trial studies the following conditions: Multiple Myeloma, Stem Cell Transplant.
What interventions are being tested in trial NCT04589286?
The interventions under investigation include: Pack Health's Digital Life Coaching (DLC) (BEHAVIORAL), Electronic Handouts (OTHER).
Who is sponsoring clinical trial NCT04589286?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04589286 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Multiple Myeloma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04589286's enrollment target sits among peer trials
60 228th of 438 higher than 205 of 438 other Multiple Myeloma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple Myeloma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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