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NCT05064787 · ClinicalTrials.gov registry record · NA
Evaluating the Feasibility of a Digital Health Coaching Program for Individuals Following CAR T Therapy
A NA study of Multiple Myeloma and Lymphoma, sponsored by Pack Health.
- Completed
- Registry status
- NA
- Development phase
- 45
- Enrollment target
- 1
- Study location
NCT05064787: Completed NA study of Multiple Myeloma and Lymphoma, sponsored by Pack Health.
NCT05064787 is a NA study of Multiple Myeloma and Lymphoma that has completed, run by Pack Health. The registered enrollment target is 45 participants, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05064787, a NA study of Multiple Myeloma and Lymphoma, has completed, sponsored by Pack Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 45 participants
- Enrollment target
- 1
- Study location
Study Summary
The aim of this study is to evaluate the feasibility of a digital health coaching program for, and to describe quality of life of, individuals in the 6 months following chimeric antigen receptor (CAR) T cell therapy. Up to 50 English-speaking individuals aged 18 and older who are to receive treatment with a CAR T cell therapy will be enrolled, all at The University of Texas MD Anderson Cancer Center. Participants must have internet access via smart phone, tablet, a computer, or another device with the capacity to receive calls, texts, or e-mails, as well as the electronic study assessments and will be excluded if they are unable to provide informed consent or have a prognosis of 6 months or less. Consented participants will be enrolled in a 6-month digital health coaching program delivered via weekly calls from a Health Advisor coupled with the digital delivery of content. The program focuses on identification and escalation of treatment-related toxicity, communication with providers, and physical and psychosocial health following treatment. Health related quality of life (HRQoL) will be assessed with the Functional Assessment of Cancer Therapy-Lymphoma (FACT-L), health self-efficacy will be assessed by the Cancer Behavior Inventory-Brief (CBI-B), physical and mental health outcomes will be measured by the National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) Global Health 10. Patient experience in managing CAR T specific care will be assessed with a 5-item questionnaire developed specifically for use in this study, focused on participants' confidence in understanding, identifying and managing symptoms, and communicating with providers. Study outcomes will contribute to knowledge about if and how a digital health intervention may be used to support individuals post-CAR T cell therapy.
Primary Outcome
Feasibility is defined as a retention rate in the digital health coaching program greater than or equal to 60% at month 6
Conditions Studied
Interventions
- BEHAVIORAL Digital Health Coaching
Study Locations (1)
Texas
- The University of Texas MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2022-03-11 |
| Est. Completion | 2024-02-06 |
| Phase | NA |
What the finished NCT05064787 record still lists
NCT05064787 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (92% lower).
The record links to 7 conditions, with Multiple Myeloma appearing as the primary indexed condition, and to 1 intervention - of which Digital Health Coaching is the first listed.
NCT05064787 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT05064787 about?
NCT05064787 is a clinical study titled "Evaluating the Feasibility of a Digital Health Coaching Program for Individuals Following CAR T Therapy". The aim of this study is to evaluate the feasibility of a digital health coaching program for, and to describe quality of life of, individuals in the 6 months following chimeric antigen receptor (CAR) T cell therapy. Up to 50 English-speaking individuals aged 18 and older who are to receive treatmen...
What is the current status of trial NCT05064787?
This trial is currently completed. It is a NA study. The enrollment target is 45 participants. The study started on 2022-03-11. Estimated completion is 2024-02-06.
What conditions does trial NCT05064787 study?
This clinical trial studies the following conditions: Multiple Myeloma, Lymphoma, Leukemia, Mantle Cell Lymphoma, Follicular Lymphoma.
What interventions are being tested in trial NCT05064787?
The interventions under investigation include: Digital Health Coaching (BEHAVIORAL).
Who is sponsoring clinical trial NCT05064787?
This trial is sponsored by Pack Health, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05064787 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Multiple Myeloma
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Where NCT05064787's enrollment target sits among peer trials
45 273rd of 438 higher than 163 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.
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