Progressive Muscle Relaxation Delivered Via Virtual Reality - an Intervention for Patients Undergoing Cellular Therapy

NCT07649512 | Not Yet Recruiting

• 1 other identifier: STUDY00006185
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Heme Malignancy

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (4)

• Change in Symptom Scores Using the Edmonton Symptom Assessment System-Revised (ESAS-r)

  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)

  Baseline (Day 1) through Day 7 following enrollment.

• Change in Muscle Relaxation Intensity Using a Visual Analog Scale (VAS)

  Baseline (Day 1) through Day 7 following enrollment.

• Participant Satisfaction with VR-Guided Progressive Muscle Relaxation Intervention Using a Post-Intervention Acceptability Survey

  Day 7 following enrollment or hospital discharge if earlier.

Study Arms (1)

Intervention arm - single arm feasibility study

EXPERIMENTAL

Patients will undergo intervention (PMR delivered via VR). All patients will undergo the intervention.

Combination Product: Progressive Muscle Relaxation delivered via Virtual Reality

Interventions

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.

Intervention arm - single arm feasibility study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to provide informed consent
• Age greater than or equal to 18 years old
• Either have a planned admission or already be admitted to the in-patient oncology ward (3NW) with cellular therapy needs.
• Able to understand English
• Able to sit-up in bed or bedside chair space to utilize VR device at the time of enrollment
• Able to utilize VR device and computer/laptop to access necessary resources for participation
• Performance Status as defined by European Cooperative Oncology Group (ECOG) score of 0-2

You may not qualify if:

• Poor performance status of ECOG 3-4
• Recent use of immersive VR programs for stress relief and/or entertainment (more than 2 days/week within the past 3 months)
• Participation in another stress-reduction type interventional study within the past 3 months
• Current or history of seizure, epilepsy, or other known severe neurological or mental health disorders
• Clinical Sensitivity to flashing light or motion or having balance disorders previously diagnosed
• 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)
• 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.

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

University of Arizona

Tucson, Arizona, 85719, United States

Location

Central Study Contacts

Renee Miu, DO

CONTACT

786-505-5779; rmiu@arizona.edu

Michele Chu-Pilli

CONTACT

520-626-1183; chum@arizona.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DO

Study Record Dates

• First Submitted: January 8, 2026
• First Posted: June 16, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: June 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 11/01/2025 - 11/01/2026
• Access Criteria: 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.

Locations

US (1)