Measuring the Feasibility and Effect of a Virtual Reality Cognitive Training Intervention for Brain Cancer Survivors.

University of Cincinnati

Status: Not yet enrolling

Conditions: Brain Cancer

Treatments: Other: Virtual Reality System; Other: Word Search Puzzles

Study type: Interventional

Funder types: Other

Identifiers

NCT07313709

UCCC-BN-25-01

Details and patient eligibility

About

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.

Full 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).

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Experimental (Virtual Reality - VR)

Experimental group

Description:

Experimental (VR) Participants ONLY: Participants randomized to using Virtual Reality-Cognitive Rehab Training (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.

Treatment:

Other: Virtual Reality System

Control (WSP)

Active Comparator group

Description:

Control (WSP) Participants ONLY: 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.

Treatment:

Other: Word Search Puzzles