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Not Yet Recruiting
NCT07649512
Progressive Muscle Relaxation Delivered Via Virtual Reality - an Intervention for Patients Undergoing Cellular Therapy
Conditions: Heme Malignancy
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 40
Sponsor: University of Arizona
Location: University of Arizona Tucson Arizona
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07649512). StuddyBuddy aggregates publicly available trial information.