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Not yet recruiting NCT07649512

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

No phase Interventional Heme Malignancy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Progressive Muscle Relaxation delivered via Virtual Reality.
Who it may be relevant to
Registry conditions: Heme Malignancy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

PMR Delivered Via VR - a Cellular Therapy Intervention

Overview

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 product Progressive 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.

Primary outcome measures

  • Recruitment, Retention, and Adherence Rates of VR-Guided Progressive Muscle Relaxation (PMR) Intervention [Time frame: Enrollment through completion of the 7-day intervention period.]
Secondary outcome measures (4)
  • Change in Symptom Scores Using the Edmonton Symptom Assessment System-Revised (ESAS-r) [Time frame: 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) [Time frame: Baseline (Day 1) through Day 7 following enrollment.]
  • Change in Muscle Relaxation Intensity Using a Visual Analog Scale (VAS) [Time frame: Baseline (Day 1) through Day 7 following enrollment.]
  • Participant Satisfaction with VR-Guided Progressive Muscle Relaxation Intervention Using a Post-Intervention Acceptability Survey [Time frame: Day 7 following enrollment or hospital discharge if earlier.]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • University of Arizona — Tucson

Identifiers

NCT: NCT07649512 · STUDY00006185

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗