Clinical trial · Interventional
Patient Reported Outcomes and Patient Education in Cellular Therapy Patients
Effect of Patient Education Regarding Emotional Stressors on Patient Reported Outcomes in Patients Undergoing Cellular Therapy (HSCT or CAR-T)
NCT04853277CI-TRIAL-00071590completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this research is to provide an educational visit addressing common emotional stressors involved in the transplant/CAR-T process, and determine if this added education improves levels of anxiety, depression, and fatigue after transplant/CART in comparison to people who do not receive the brief educational visit.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| CAR T-Cell Therapy | — | UNRESOLVED | — |
| CAR T-Cell Transplant | — | UNRESOLVED | — |
| Cellular Therapy | — | UNRESOLVED | — |
| Hematopoietic Stem Cell Transplant | — | UNRESOLVED | — |
| HSCT | — | UNRESOLVED | — |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Stem Cell Transplant | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Education | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Education Group
- description
- Participants will receive an educational intervention focusing on psychosocial stressors and timeline of symptoms associated with the transplant/CAR-T experience.
- interventionNames
- Behavioral: Education
Primary outcomes (2)
- measure
- Change in levels of anxiety, depression, and fatigue as measured by PROMIS-29
- timeFrame
- Baseline (pre-transplant) and 1, 3, 6, and 12-months post-transplant/CAR-T
- description
- Patient-Reported Outcomes Measurement Information System (PROMIS-29) includes 29 questions for 8 categories (Physical Function, Anxiety, Depression, Fatigue, Sleep Disturbance, Ability to Participate in Social Roles and Activities, Pain Interference, and Pain Intensity) with a Likert scale from 1-5. Transformed scores will be used in analysis. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. For the categories measured in this study (Anxiety, Depression, and Fatigue) a higher value represents greater symptom burden, while a lower value represents lower symptom burden.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Any patient with an underlying hematologic disease planning to undergo an autologous or allogeneic hematopoietic stem cell transplant (HSCT) or chimeric antigen receptor T-cell (CAR-T) therapy at Dartmouth-Hitchcock Medical Center is eligible. * The patient must be approved for HSCT/CAR-T by the treating transplant physician. This includes completion of their pre-treatment work up and consent as directed by the standard DHMC SOPs. \- Age \>18 years, and no upper age limit Exclusion Criteria: * Any patient with medical, social, or psychological factors that would prevent the patient from cooperating with the trial and completing surveys at requested intervals.
References
Publications (0)
Data not yet available
No reference posted for this study.