Brain Cancer
Conditions
Keywords
virtual reality, cognitive impairment, brain cancer, cancer survivorship, non-invasive therapeutic medicine
Brief summary
The study is focused on assessing the feasibility and effect of a virtual reality training intervention for improving the survivorship journey of brain cancer survivors, post-treatment. The gaming intervention is intended to reduce cognitive impairment, while increasing well-being, mental health, and quality of life.
Detailed description
This study is focused on assessing the feasibility, acceptability and effect of a virtual reality training intervention for improving the survivorship journey of brain cancer survivors, post-treatment. The gaming intervention is intended to reduce cognitive impairment, while increasing well-being, mental health, and quality of life. In sum, the potential impact of this research is to realize the capability of virtual reality cognitive rehabilitation training (VR-CRT) by mitigating brain cancer survivors (BCS) cognitive decline, while improving overall quality of life (QOL).
Interventions
Participants randomized to using VR-CRT will have the game already installed/uploaded in the VR headset and ready for use, with their pre-determined participant number for user login and password assigned.
OTHERWord Search Puzzles
Participants randomized to the control group will have their WSP packet with pre-selected word puzzles that provide a cognitive stimulus but without an increase in complexity. The instructions provided will state how participants should complete the WSP day-by-day. The dated completed WSPs, along with weekly check-ins by the study CRC will constitute the record for the participant's progress over four weeks. CRCs will notify the PI via email if during the call the participant indicates they have missed any of the WSPs during a given week.
Sponsors
University of Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
After eligibility is confirmed, participants will be randomized into either the Experimental (Virtual Reality) or Control (Word Search Puzzles) Arms. Participants will be randomized in blocks of 4 through a computer-generated randomization such that the final n in the experimental arm is 20 and the control arm is 20. If a participant has to drop out of the study for any reason after randomization and start of the baseline/onboarding phase (e.g., due to motion sickness during participation) this will be considered in the assessment of feasibility for this study and they will not be replaced. The UCCC Data Manager will issue subject randomization to the study team upon receipt of confirmation of eligibility (with eligibility being confirmed per UCCC CTO workflows).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Low grade glioma survivors. 2. Have mild cognitive impairment (MCI) per MoCA (defined as any score between 18 and 25). 3. Completed all cancer treatment for their low-grade glioma (including chemotherapy, immunotherapy, radiation therapy and surgical procedures) and are now \>30 days to 24 months from the date of last treatment. 4. Age 18 years or older. 5. English speaking. 6. Able to provide consent without use of a Legally Authorized Representative 7. Available to play the VR game or complete word search puzzles once per day for six days per week for four consecutive weeks in their home (per patient self-report). 8. Have a reliable phone number by which they can be reached to make arrangement for testing and for follow-up calls.
Exclusion criteria
* 1\. History of serious mental or severe psychiatric illnesses (e.g., bi-polar disorder, schizophrenia etc....). a. Note: Anxiety or depression are not exclusionary. 2. History or known neurodegenerative diseases such as Alzheimer's disease, vascular dementia or any other form of advanced neurodegenerative or neuro-cognitive diseases. 3\. History of drug intoxication/overdose (addiction history). 4. History of acute traumatic brain injury. 5. History of stroke causing a cognitive deficit only. 6. Vision impairments including legal blindness. a. Note: patients with corrected vision (e.g., glasses or contacts) or who are color-blind are eligible. 7\. Incarcerated at the time of study enrollment. 8. Enrolled in another clinical trial which does not permit co-enrollment. 9. Any medical condition precluding safe use of VR headset and hand control technology, including patients with medical devices, including cardiac pacemakers, hearing aids/cochlear implants and defibrillators. 10\. History of motion sickness per patient self-report.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility defined as >80% (> 16 participants out of 20) able to complete the experimental arm study in 4 weeks. | 4 weeks | FEASIBILITY: Measure the feasibility of using VR-CRT and Control (i.e., paper-based Word-search puzzles (WSP)) with brain cancer survivors (BCS) experiencing cancer-related cognitive impairment (CRCI). Feasibility: will be defined as \>80% (\> 16 participants out of 20) able to complete the experimental arm study in 4 weeks. Since the standard/control arm is well established and routine, feasibility evaluation is not required in this arm. (If subjects withdraw in disproportion in two arms after the randomization, the study may be suspended for further evaluation.) |
| Acceptability defined as scores of >8 on each subscale of the Senior Technology Acceptance Model (STAM).54 The STAM (Short Version) measures four attitudes towards technology on a Likert scale of 1-10. | 4 weeks | ACCEPTABILITY: Measure the acceptability of using VR-CRT and Control (i.e., paper-based Word-search puzzles (WSP)) with brain cancer survivors (BCS) experiencing cancer-related cognitive impairment (CRCI). Acceptability: will be defined as scores of \>8 on each subscale of the Senior Technology Acceptance Model (STAM).54 The STAM (Short Version) measures four attitudes towards technology on a Likert scale of 1-10. (See sections 3.1, 17.1 for detail.) This score of \>8 for all 14 responses will be calculated as an average of all of the completed sub-scales per each subject. Any missing sub-scales (non-response by subjects) will not be considered into the calculation of the mean per subject. The score of \>8 must be observed in \>80% (\>32 participants) to be considered acceptable. |
| Effect of VR-CRT (and Control) on cognitive function measured by scores at baseline and post-intervention,using 1.) Hopkins Verbal Learning Test | 4 weeks | EFFECT: Estimate the effect of VR-CRT (and Control) on brain cancer survivors' cognitive function such as memory, attention/focus, processing speed, and executive function. Effect: will be measured by 1.) Hopkins Verbal Learning Test (HVLT) |
| Effect of VR-CRT (and Control) on cognitive function measured by scores at baseline and post-intervention,using 2.) Controlled Oral Word Association | 4 weeks | EFFECT: Estimate the effect of VR-CRT (and Control) on brain cancer survivors' cognitive function such as memory, attention/focus, processing speed, and executive function. Effect: will be measured by comparing scores collected at baseline and post-intervention, (i.e., at the conclusion of a four-week intervention period) using 2.) Controlled Oral Word Association (COWA) |
| Effect of VR-CRT (and Control) on cognitive function measured by scores at baseline and post-intervention,using 3.) Trail Making A-B | 4 weeks | EFFECT: Estimate the effect of VR-CRT (and Control) on brain cancer survivors' cognitive function such as memory, attention/focus, processing speed, and executive function. Effect: will be measured by comparing scores collected at baseline and post-intervention, (i.e., at the conclusion of a four-week intervention period) using 3.) Trail Making A-B (TMa/b). |
Countries
United States
Contacts
Primary ContactUCCC Clinical Trials Office
Backup ContactAnthony Faiola, PhD
Outcome results
None listed