Heme Malignancy
Conditions
Brief summary
Patients planned for cellular therapy supplementation such as CAR-T or stem cell transplant who are admitted for atleast 7 days in patient. During that time of admission, patients enrolled will complete a once daily, virtual reality guided progressive muscle relaxation program. Various validated QOL tools will be utilized to assess study results.
Interventions
COMBINATION_PRODUCTProgressive Muscle Relaxation delivered via Virtual Reality
Patients will utilize VR headset in the intervention arm. This headset will be pre-populated with PMR guided meditation videos.
Sponsors
University of Arizona
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Able to provide informed consent 2. Age greater than or equal to 18 years old 3. Either have a planned admission or already be admitted to the in-patient oncology ward (3NW) with cellular therapy needs. 4. Able to understand English 5. Able to sit-up in bed or bedside chair space to utilize VR device at the time of enrollment 6. Able to utilize VR device and computer/laptop to access necessary resources for participation 7. Performance Status as defined by European Cooperative Oncology Group (ECOG) score of 0-2
Exclusion criteria
1. Poor performance status of ECOG 3-4 2. Recent use of immersive VR programs for stress relief and/or entertainment (more than 2 days/week within the past 3 months) 3. Participation in another stress-reduction type interventional study within the past 3 months 4. Current or history of seizure, epilepsy, or other known severe neurological or mental health disorders 5. Clinical Sensitivity to flashing light or motion or having balance disorders previously diagnosed 6. Having another medical condition or co-morbidity that may prevent use of VR program or physical materials (e.g., visual or hearing problems, open sores, wounds, skin rash on face, or active infection) 7. Patients with concern for neurotoxicity or acute treatment related neurological issues such as ICANS. ICANS grade 1 maybe eligible to re-enter trial. ICANS grade 2 or greater would be permanently excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment, Retention, and Adherence Rates of VR-Guided Progressive Muscle Relaxation (PMR) Intervention | Enrollment through completion of the 7-day intervention period. | Feasibility will be assessed using three operational metrics: Recruitment rate - the proportion of eligible patients who consent to participate in the study. Retention rate - the proportion of enrolled participants who complete the 7-day intervention period. Adherence rate - the proportion of participants who complete at least 5 VR-guided PMR sessions lasting up to 20 minutes each during the first 7 days of hospitalization. These outcomes will be summarized descriptively as proportions and percentages among enrolled participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Symptom Scores Using the Edmonton Symptom Assessment System-Revised (ESAS-r) | Baseline (Day 1) through Day 7 following enrollment. | The Edmonton Symptom Assessment System-Revised (ESAS-r) is a validated patient-reported symptom assessment tool used to measure common physical and psychological symptoms in patients with cancer. The ESAS-r assesses nine symptoms (pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being, and shortness of breath) using a numeric rating scale from 0 to 10 for each symptom, where 0 indicates no symptom and 10 indicates the worst possible symptom severity. Changes in individual symptom scores and total symptom burden will be summarized descriptively from baseline to Day 7 following the intervention. |
| Change in Health-Related Quality of Life Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) | Baseline (Day 1) through Day 7 following enrollment. | The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) is a validated patient-reported instrument used to assess health-related quality of life in patients with cancer. The questionnaire contains 30 items assessing global health status, functional domains (physical, role, cognitive, emotional, and social functioning), and symptom domains. Scores are transformed to a 0-100 scale according to the EORTC scoring manual. For the global health status and functional scales, higher scores indicate better quality of life and functioning, whereas for the symptom scales, higher scores indicate greater symptom burden. Changes in global health status and symptom scores from baseline to Day 7 will be summarized descriptively. |
| Change in Muscle Relaxation Intensity Using a Visual Analog Scale (VAS) | Baseline (Day 1) through Day 7 following enrollment. | Perceived muscle tension and relaxation will be assessed using a Visual Analog Scale (VAS). Participants will rate their perceived level of muscle tension and relaxation on a numeric scale from 0 to 10, where 0 represents no tension/complete relaxation and 10 represents the highest level of tension or discomfort. Scores will be recorded before and after progressive muscle relaxation (PMR) sessions, and changes in VAS scores over the 7-day intervention period will be summarized descriptively. |
| Participant Satisfaction with VR-Guided Progressive Muscle Relaxation Intervention Using a Post-Intervention Acceptability Survey | Day 7 following enrollment or hospital discharge if earlier. | Participant acceptability of the intervention will be assessed using a brief post-intervention acceptability survey administered at Day 7 (or discharge if earlier). Participants will rate overall satisfaction, usability, comfort, and willingness to use the VR-guided progressive muscle relaxation intervention again using 5-point Likert scale responses ranging from 1 to 5, where 1 indicates very dissatisfied and 5 indicates very satisfied. Higher scores indicate greater satisfaction and acceptability of the intervention. Responses will be summarized descriptively. |
Countries
United States
Contacts
CONTACTRenee Miu, DO
CONTACTMichele Chu-Pilli
Outcome results
None listed