Heme MalignancyNCT07649512
Progressive Muscle Relaxation Delivered Via Virtual Reality - an Intervention for Patients Undergoing Cellular Therapy
A study testing Progressive Muscle Relaxation delivered via Virtual Reality in people with Heme Malignancy, run by University of Arizona at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heme Malignancy
- What is being tested?
- Progressive Muscle Relaxation delivered via Virtual Reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2026to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Arizona
Tucson, Arizona, 85719
Renee Miu, DO, 623-570-8939, rmiu@arizona.edu
Michele Chu-Pilli, chum@arizona.edu
About this study
Official title: PMR Delivered Via VR - a Cellular Therapy Intervention
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
- Being tested
- Progressive Muscle Relaxation delivered via Virtual Reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Muscle Relaxation delivered via Virtual RealityCombination product
Patients will utilize VR headset in the intervention arm. This headset will be pre-populated with PMR guided meditation videos.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm - single arm feasibility study | Experimental | Patients will undergo intervention (PMR delivered via VR). All patients will undergo the intervention. Receives: Combination Product: Progressive Muscle Relaxation delivered via Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 7 following enrollment or hospital discharge if earlier.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study startAug 2026 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heme MalignancyStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renee Yin Shen Miu, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07649512
- Sponsor's protocol ID
- STUDY00006185
- Status last verified
- Jun 2026
- First submitted
- 8 Jan 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Protocol and Study statistical plan will be shared. Informed consent will also be shared.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PMR Delivered Via VR - a Cellular Therapy Intervention
- ClinicalTrials.gov ID
- NCT07649512
- Acronym / sponsor ID
- STUDY00006185
- Conditions
- Heme Malignancy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 16 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention arm - single arm feasibility study | Experimental | Combination Product: Progressive Muscle Relaxation delivered via Virtual RealityPatients will undergo intervention (PMR delivered via VR). All patients will undergo the intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progressive Muscle Relaxation delivered via Virtual RealityPatients will utilize VR headset in the intervention arm. This headset will be pre-populated with PMR guided meditation videos. | Combination product | Intervention arm - single arm feasibility study |
Primary outcome
Recruitment, Retention, and Adherence Rates of VR-Guided Progressive Muscle Relaxation (PMR) Intervention
Time frame: 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.
4 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: Yes. Protocol and Study statistical plan will be shared. Informed consent will also be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive Muscle Relaxation delivered via Virtual Reality in people with Heme Malignancy, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Renee Miu, DO (786-505-5779, rmiu@arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment, Retention, and Adherence Rates of VR-Guided Progressive Muscle Relaxation (PMR) Intervention (time frame: Enrollment through completion of the 7-day intervention period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.