NCT04972019

Telerehabilitation Cognitive Impairments Following Chemotherapy Feasibility Study

Home-based Virtual Reality System for the Treatment of Chemotherapy-related Cognitive Impairments - Feasibility Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Bright Cloud International Corp · Industry
• Sex: Female
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Develop a game-based upper-extremity motor and cognitive rehabilitation system using custom and adaptable virtual reality simulations on a wearable device enhanced with biosensors. Participants are stage II and stage III breast cancer survivors with lasting cognitive impairments following their first round of chemotherapy. They will be randomized 1:1 into an experimental group and a sham control group. Each group will train in the home for 8 weeks, during which they will perform up to 4 rehabilitation sessions/week (based on tolerance). Each session will start with vitals being measured and logged. Each group will have three clinical evaluations: 1) at baseline; 2) at 8 weeks post-baseline; and 3) at 16 weeks from baseline for follow up. Experimental group sessions will consist of increasingly more difficult cognitive training tasks in the form of simulated tasks. Biosensors will be sampled while participants interact with these games while wearing the computer system. Sham control group will have the same number, suration and frequency of sessions, however they will play web games while wearing some the same biosensors. Caregivers of all subjects will receive a laptop to be used in filling subjective evaluation forms and sending messages to research team. Training will be in the home, so caregivers will need to support the trials by ensuring compliance with the protocol. All subjects will undergo standardized clinical evaluations at baseline, at 8 weeks and at 16 weeks from baseline. The subjects in the experimental group will have computerized measures taken during each session, and will fill subjective evaluation forms every 4 weeks of active training.

Detailed description

This portion of the study is intended to provide information pertaining to the feasibility of the experimental system for remote integrative (cognitive and motor) therapy of breast cancer survivors (Stage II or III) with lasting cognitive impairments subsequent to their first chemotherapy regimen, and living in the community with a caregiver. We aim primarily at determining any clinical benefits in improved cognition (primarily in the executive functions domain), but also increased independence in ADLs, and improved mood (reduced depression). Another outcome is the degree of technology acceptance by the targeted population. Training will be done in the home, thus co-dwelling caregivers will also be recruited. Specific aims are: 1. testing of a wearable device modified with added biosensors, by breast cancer survivors with CRCI. 2. new technology acceptance and ease of use at home by these individuals; 3. clinical benefit to improved cognition (primarily executive functions and cognitive endurance) when experimental therapy is added to daily routine vs. daily routine plus web-based cognitive games; 4. a therapist console module and enhanced automatic session report that will allow remote monitoring of patient exercising and offline data processing and review. Participants will be randomized equally in an experimental group, or a sham control group. Experimental subjects will receive computer-based therapy, of increasing duration and intensity for up to 4 sessions/week for 8 weeks. The length of sessions will increase from 15 minutes in week 1 to 40 minutes of actual play in week 8. The longer sessions will also train cognitive endurance, or the ability for sustained cognitive effort. All experimental subjects will have their exercise duration and intensity data logged into the database and investigators will monitor them remotely. An Artificial Intelligence (AI) software layer in the system will progress game difficulty based on success in the games as well as on degree of cognitive engagement, as estimated by the biosensors. Higher cognitive difficulty will be indicative of improved cognition, thus progress in mitigating cognitive impairments subsequent to chemotherapy. Additionally, the duration of training will also be logged, as will be the frequency of training. Longer sessions will be indicative of ability to sustain cognitive engagement longer. Additional input will be obtained from caregivers in the form of periodic questionnaires. Fatigue will be self-reported during weekly follow up calls by a Clinical Coordinator. Participants will train while seated, and (if needed) their arms can be supported on a table. Rest periods may be introduced as needed, to further mitigate fatigue. At the end of every other week participants and their caregivers in the experimental group will fill a subjective evaluation questionnaire aimed at gauging perceived benefits and possible technical difficulties when using the BrightGo system. Questions will be scored on a 5-point Likert scale. Control group will perform an equal amount of web-based game play of assigned cognitive-oriented games. All participants will undergo screening for cognitive impairments (to confirm Mild Cognitive Impairment at baseline). Then they will continue with their daily routine during their 8-week training, and will undergo a second clinical evaluation at the end of these 8 weeks. All participants will then undergo a third (follow up) evaluation at 8 weeks post-end of training. Caregivers will support the training by helping ensure compliance to protocol, and will complete subjective evaluation forms to rate the perceive benefit of training for the person they care for. All participants will receive a weekly call from the Clinical Coordinator so to report on any health concerns and system issues.

Conditions

• Cognitive Impairment, Mild

Interventions

Type	Name	Description
DEVICE	Telerehabilitation Experimental Group	Experimental training will occur in the home. The experimental training will last 8 weeks, each week having up to 4 sessions of therapeutic game play (based on tolerance). Each session will start with vitals and subjective pain level being measured and logged. They will wear a computer system modified with biosensors, then do motor and cognitive baselines. Subsequently, participants will play an increasing number of games, targeted at cognitive domains of executive function (primary), memory and attention. At the end of every session vitals and subjective pain will be measured and logged. Clinical Coordinator will call homes weekly to ascertain general health and issues with participation. At the end of week 4 and 8 participants and their caregivers in the experimental group will fill a subjective evaluation questionnaire to gauge perceived benefits and technical difficulties when using the experimental system. Questions will be scored on a 5-point Likert scale.
OTHER	Telerehabilitation Sham Control Group	Sham control group will train playing web games while wearing a biosensor connected to a laptop provided, showing the web games. However biosensor data will not be used to control game difficulty. Sham group controls will start every session with vitals and subjective pain levels being measured and logged. Then participants will play the same frequency and duration of sessions, however those will consist of web games training the same domains (memory, focusing, executive function). Interaction will be through a mouse, and data will be downloaded to a server maintained by the company doing the web games. Data will then be transferred to the research team. At the end of every session vitals and subjective pain levels will again be measured and logged. Once a week the Clinical Coordinator will call the home to ascertain general health and determine is there were issues with that week participation.

Timeline

• Start date: 2022-02-09
• Primary completion: 2022-09-30
• Completion: 2022-09-30
• First posted: 2021-07-22
• Last updated: 2022-05-02

Locations

2 sites across 1 country: United States