Cancer
Conditions
Keywords
Virtual Reality, Relaxation, Mindfulness
Brief summary
The purpose of this study is to assess the feasibility of a pre-simulation virtual reality (VR) platform designed to promote relaxation for cancer patients planned for radiation therapy (RT).
Detailed description
The purpose of this prospective feasibility study is to assess the implementation of a VR-based intervention in patients who are pending initiation of RT. The investigators hypothesize that this intervention will be safe and feasible. If 75% of enrolled patients complete the VR intervention (defined as at least 8 min before permanent discontinuation), then feasibility will be met. Ten minutes' length is likely to be tolerated by most patients and likely to provide benefit. The maximum length of the VR video is 11 minutes. Patients will still be evaluable after 8 minutes of the video as this provides ample time to practice mindfulness based breathing exercises. As this is a feasibility study, investigators and participants will not be blinded to study procedures. Potential study participants will be adult patients who are undergoing simulation for radiation treatment planning at the Perelman Center for Advanced Medicine at Penn Medicine. This is a single site study. No interim analyses or sub-studies are planned. Based on the expected accrual of 25 patients, futility and early termination will be triggered if 6 participants fail to meet the conditions described above.
Interventions
Study participants will be provided a HTC or Pico VR head-mounted device (HTC Flow, HTC Focus or Pico Neo Pro) which will be fitted for comfort. Patients will remain seated for the entirety of the VR program. The program generally takes about ten minutes to complete but may last up to 11 minutes. The program displays a relaxing environmental setting with narration based in mindfulness meditation principles. Subjects will be prompted to practice breathing exercises designed to relax and reduce anxiety.
Sponsors
Abramson Cancer Center at Penn Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Able to understand, read or speak English sufficient for signing of informed consent and completion of study assessments 2. Patients scheduled for simulation for radiation treatment planning at Perelman Center for Advanced Medicine (PCAM) 3. Adults, at least 18 years of age 4. Performance Status (ECOG) 0-2
Exclusion criteria
1. Prior radiotherapy 2. History of motion sickness, car sickness, vertigo, migraines, or light sensitivity within the last 6 months 3. History of epilepsy and seizures 4. Current nausea, vomiting, dizziness, lightheadedness, monocular vision or hearing loss that is not treated
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of a Pre-simulation VR Platform Prior to Radiation | 1 Day | Feasibility based on the ability of at least 75% patient VR completion rate. Based on the expected accrual of 25 patients, futility and early termination will be triggered if six participants fail to meet the conditions described above. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Situational Anxiety Prior to and After Use of VR Program (HADS) | 1 Day | Prior to the intervention, patients completed the Hospital Anxiety and Depression Scale (HADS). The HADS is a 14-item questionnaire that includes two 7-item subscales assessing anxiety (HADS-A) and depression (HADS-D), each rated on a 0-3 scale. Raw scores range from 0-21 with higher scores indicating higher anxiety or depression, for each subscale respectively. Scores on a scale greater than eight indicate clinically significant anxiety or depression. This survey was only delivered at one time-point which was prior to use of the VR program. |
| Patient Situational Anxiety Prior to and After Use of VR Program (STAI-6) | 1 Day | The State-Trait Anxiety Inventory (STAI-6) is a validated short form of the 20-item STAI 6-item questionnaire. It contains six items ("I am tense", "I feel upset", "I am relaxed", "I feel content", "I am worried", "I feel calm.") rated on a 1-4 Likert scale to assess situational anxiety. Raw scores range from 6-24, with higher scores indicating higher situational anxiety. Total STAI-6 scores are multiplied by 20 and divided by six to give a score between 20-80, consistent with the 20-item questionnaire. Scores on a scale of 40 or higher is correlated with clinically significant anxiety. The STAI-6 was delivered at two time-points, prior to and after use of the VR program. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMichael LaRiviere, MD
University of Pennsylvania
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 11 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants |
| Age, Continuous | 65 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 21 Participants |
| Region of Enrollment United States | 25 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
None listed