PMR Delivered Via VR - a Cellular Therapy Intervention
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Recruitment, Retention, and Adherence Rates of VR-Guided Progressive Muscle Relaxation (PMR) Intervention
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Intervention arm - single arm feasibility study
Patients will undergo intervention (PMR delivered via VR). All patients will undergo the intervention.
干预措施: Progressive Muscle Relaxation delivered via Virtual Reality (Combination Product)
结局指标
主要结局
Recruitment, Retention, and Adherence Rates of VR-Guided Progressive Muscle Relaxation (PMR) Intervention
时间窗: 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.
次要结局
- 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.)
研究者
Renee Yin Shen Miu
DO
University of Arizona