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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention arm - single arm feasibility study | Experimental | Patients will undergo intervention (PMR delivered via VR). All patients will undergo the intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Progressive Muscle Relaxation delivered via Virtual Reality | Combination Product | Patients will utilize VR headset in the intervention arm. This headset will be pre-populated with PMR guided meditation videos. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment, Retention, and Adherence Rates of VR-Guided Progressive Muscle Relaxation (PMR) Intervention | 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. | Enrollment through completion of the 7-day intervention period. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Symptom Scores Using the Edmonton Symptom Assessment System-Revised (ESAS-r) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Renee Miu, DO | Contact | 786-505-5779 | rmiu@arizona.edu | |
| Michele Chu-Pilli | Contact | 520-626-1183 | chum@arizona.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona | Tucson | Arizona | 85719 | United States |
Protocol and Study statistical plan will be shared. Informed consent will also be shared.
11/01/2025 - 11/01/2026
Clinicians and researchers interested in this study will be able to access IPD. These will be uploaded to the clinical trials.gov website. They will be able to access protocol, informed consent sheet as well as statistical analysis portrayed on protocol.
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| Baseline (Day 1) through Day 7 following enrollment. |
| 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) | 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. | Baseline (Day 1) through Day 7 following enrollment. |
| Change in Muscle Relaxation Intensity Using a Visual Analog Scale (VAS) | 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. | Baseline (Day 1) through Day 7 following enrollment. |
| Participant Satisfaction with VR-Guided Progressive Muscle Relaxation Intervention Using a Post-Intervention Acceptability Survey | 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. | Day 7 following enrollment or hospital discharge if earlier. |