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NCT05064787
Evaluating the Feasibility of a Digital Health Coaching Program for Individuals Following CAR T Therapy
NA trial testing Digital Health Coaching in Lymphoma in 45 participants. Completed in 6 February 2024.
6 February 2024
Quick facts
| Lead sponsor | Pack Health |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 45 |
| Start date | 11 March 2022 |
| Primary completion | 6 February 2024 |
| Estimated completion | 6 February 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Digital Health Coaching
Conditions studied
- Lymphoma — all drugs for Lymphoma →
- Lymphoma, B-Cell — all drugs for Lymphoma, B-Cell →
- Leukemia — all drugs for Leukemia →
- Multiple Myeloma — all drugs for Multiple Myeloma →
Sponsor
Pack Health
Who can join
18 and older, any sex, with Lymphoma or Lymphoma, B-Cell. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05064787
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Digital Health Coaching
Trials testing the same drug.
- NCT05288452 — Food Delivery, Remote Monitoring, and Coaching-Enhanced Education for Optimized Diabetes Management (FREEDOM) · NA · active not recruiting
- NCT05199961 — Quality of Life of Adults With Diffuse Large B-cell Lymphoma Treated With Tisagenlecleucel · NA · terminated
Other recruiting trials for Lymphoma
Currently open trials in the same condition.
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- NCT07566377 — Cord Blood Transplantation in Children and Young Adults With Blood Cancer · Phase 2 · recruiting
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- NCT07226934 — An AI-Generated, Personalized Question Prompt List Intervention for Patients With Hematologic Cancers · NA · recruiting
- NCT07138547 — GSL Synthetase Inhibitor Eliglustat Combined With CD30 Target Immunotherapy for the Treatment of of CD30+ Lymphoma · Phase 1, PHASE2 · recruiting
Other Pack Health trials
Trials by the same sponsor.
- NCT05956457 — PRO and Wearable Data Insights From Individuals With R/R Multiple Myeloma · NA · recruiting
- NCT05053607 — Real World Insights During Treatment for Relapsed/Refractory Multiple Myeloma with Isatuximab · NA · recruiting
- NCT05199961 — Quality of Life of Adults With Diffuse Large B-cell Lymphoma Treated With Tisagenlecleucel · NA · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05064787 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Pack Health
- Last refreshed: 24 May 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05064787.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing