Clinical trial NCT04839588: Telerehabilitation Cognitive Impairments Following Chemotherapy Usability Study
Official title: Home-based Virtual Reality System for the Treatment of Chemotherapy-related Cognitive Impairments
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chemotherapy-Related Cognitive Impairment
Healthy
Keywords: chemotherapy
cognitive impairments
breast cancer
Lead sponsor: Bright Cloud International Corp
Sponsor class: INDUSTRY
Collaborators: name: National Cancer Institute (NCI)
name: Rutgers, The State University of New Jersey
First posted: 2021-04-09
Enrollment: 4
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The targeted subjects will be either breast cancer survivors, living in the community, without requiring transfers, or healthy, age-matched volunteers.

Brief summary: Develop a game-based upper-extremity motor and cognitive rehabilitation system using custom and adaptable virtual reality simulations.

Perform usability study on 2 elderly healthy volunteers and 2 breast cancer survivors with lasting cognitive impairments following chemotherapy, so to improve the product design. The usability evaluation will be done at NJ Bioscience Center (North Brunswick, NJ).

Detailed description: The study will generate data on ease of use of a system for subjects with stage II or stage III breast cancer survivors with lasting cognitive impairments subsequent to their first chemotherapy regimen. The usability component will uncover technical issues in its usability, as well as its rating on perceived usefulness. Data will also be collected on the ease of remote monitoring of the subjects by clinicians.

This portion of the study is intended to provide information pertaining to the usability of the experimental system for remote integrative (cognitive and motor) therapy of breast cancer survivors (Stage II or III) with lasting chemotherapy related cognitive impairment (CRCI) subsequent to first chemotherapy regimen, living in the community.

Specific aims are:

1. testing of a added biosensors, new technology acceptance and ease of use at home by these individuals;
2. a caregiver console and enhanced automatic session report that will allow remote monitoring of patient exercising and offline data processing and review.

Participants will each perform 4 usability evaluation sessions. At the end of each session participants will fill a custom evaluation form, using 5-point Likert scale scoring. At the end of the last session participants will also fill a USE standardized usability evaluation form.

Eligibility criteria: At NJ Bioscience Center Healthy Volunteers

* Female
* Age 20 to 65;
* Good or corrected hearing;
* Good or corrected vision;
* No motor or cognitive impairments;
* English speakers;
* Those with low propensity for simulation sickness (as determined by the Simulation Sickness Questionnaire \[Kennedy et al, 1993\]).
* Either healthy or having had stage II or stage III breast cancer;
* Montreal Cognitive Assessment (MoCA) Score 10-25 indicating mild to moderate impairment \[Chapman 2016\] or 26-30 indicating normal cognition;

EXCLUSION CRITERIA

* Male;
* Female participants younger than 20 or older than 65;
* High propensity for simulation sickness (as determined by Simulation Sickness Questionnaire screening);
* Those with severe visual neglect or legally blind;
* Those with severe hearing loss or deafness;
* Those with uncontrolled hypertension (\>190/100 mmHg);
* Those with severe cognitive impairment (MoCA score\<10);
* Current diagnosis of moderate-severe depression (Beck Depression Inventory II score of 17-63);
* a history of psychiatric illness, defined as serious psychiatric illness such as bipolar mood disorder and schizophrenia, or requiring psychiatric hospitalization.
* a history of or current substance abuse;
* a previous head injury resulting in loss of consciousness;
* a prior diagnosis of neurological illness;
* a current or prior diagnosis of brain cancer;
* non-English speakers;
* Those unable to reliable participate in pre-study assessment due to any reason;
* Those with co-morbidities limiting arm and neck motor function (ex. lymphedema, chronic pain, severe arthritis);
* Less than 1 month post first chemotherapy regimen or starting chemotherapy during 16 weeks post screening (as chemotherapy during study participation is a confounding factor);
* Those with Stage IV (metastatic) breast cancer will be excluded;
* Those presenting with multiple cancers, such as breast and arm bone cancer, or breast and brain cancer;
* Those who are unwilling to allow a home inspection to ascertain Internet quality, determine best placement for the experimental or sham systems, for installation and removal of the systems and necessary repairs.

Primary outcomes:
measure: USE questionnaire to assess the usability of a computerized system
timeFrame: At the end of the 4th evaluation session (about 1 month from enrollment)
Secondary outcomes:
measure: Subjective rating questionnaire of the device and therapy
timeFrame: At each of 4 evaluation sessions over 1 month from enrollment
Other outcomes:
measure: Simulation Sickness Questionnaire for participant
timeFrame: Screening at consent (one time)
measure: Cyber-sickness Susceptibility Questionnaire for participant
timeFrame: Screening at consent (one time)
measure: Montreal Cognitive Assessment (MoCA) to measure level of cognitive impairment
timeFrame: Screening at consent (one time)
measure: Biosensor readings
timeFrame: At each of 4 evaluation sessions over 1 month from enrollment
measure: Game difficulty level
timeFrame: At each of 4 evaluation sessions over 1 month from enrollment
measure: Heart rate
timeFrame: Before and after each of 4 evaluation sessions over 1 month from enrollment
measure: Blood pressure (systolic and diastolic)
timeFrame: Before and after each of 4 evaluation sessions over 1 month from enrollment
Locations:
city: North Brunswick
country: United States
facility: Bright Cloud Int'l Corp
state: New Jersey
city: North Brunswick
country: United States
facility: New Jersey Bioscience Center
state: New Jersey
Study officials:
affiliation: Bright Cloud Int'l Corp
name: Grigore C Burdea, PhD
role: PRINCIPAL_INVESTIGATOR
References: