Telerehabilitation Cognitive Impairments Following Chemotherapy Usability Study (TCIFCU)

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

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).

Study Overview

• Status: Completed
• Conditions: Healthy; Chemotherapy-Related Cognitive Impairment
• Intervention / Treatment: Other: Usability study

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.

• Study Type: Observational
• Enrollment (Actual): 4

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • North Brunswick, New Jersey, United States, 08902
      • Bright Cloud Int'l Corp
    • North Brunswick, New Jersey, United States, 08902
      • New Jersey Bioscience Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Usability study, healthy volunteers and those with cognitive impairments following chemotherapy; 2 elderly healthy volunteers and 2 participants with lasting cognitive impairments following chemotherapy for breast cancer. All will perform evaluation of a computer-based experimental system. Participants will be; Female Either healthy or breast cancer survivor;; Age 20 to 65 years;; Have st least 12 years of formal education;; Be English speakers;

Other: Usability study; Participants will first be screened for propensity to simulation sickness and for cognitive state using the MoCA evaluation test. Those who passed the screening will perform 4 usability sessions rating the ease of use and perceived benefit of the experimental system and of a caregiver interface laptop. The 2 healthy volunteers will evaluate first, such that issues may be resolved before testing is done on the impaired participants. Each session will be compensated with a $35 payment. During each session participants will play a series of increasing difficulty simulated tasks, aimed to train primarily the executive functions domain. At the end of each session participants will rate their experience using custom subjective evaluation forms with multiple items. Each item will be scored using a 5-point Likert scale. At the end of the 4th session, participants will also fill the USE standardized usability form. This usability evaluation will be conducted at the NJ Bioscience Center.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
USE questionnaire to assess the usability of a computerized system	A standardized questionnaire to assess the usefulness, satisfaction and ease of use of the experimental system [Lund, 2001] when evaluated by study participants. The form consists of 30 questions, each rated on a 7-point Likert scale (1 worst 7 best). The score range for this form is 30 (min) to 210 (max). Participants will also be able to comment in free form on aspects they liked most and least about the device.	At the end of the 4th evaluation session (about 1 month from enrollment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective rating questionnaire of the device and therapy	Participants rate the usefulness, satisfaction issues, and ease of use of the experimental system and its therapeutic games, as well as ease of use of the Caregiver laptop. The Subjective Evaluation Form consists of questions, each rated on a 5-point Likert scale (1 worst to 5 best outcome).	At each of 4 evaluation sessions over 1 month from enrollment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Simulation Sickness Questionnaire for participant	Form used at screening post-consent to determine a participant's propensity for simulation sickness [Kennedy et al.,1993]. The questionnaire asks participants to score 16 symptoms on a four point scale (0-3). Score range is 0 (best outcome - no likelihood of experiencing simulation sickness with the device) to 48 (worst outcome - certainty that the participant will experience severe simulation sickness).	Screening at consent (one time)
Cyber-sickness Susceptibility Questionnaire for participant	Form used at screening post-consent to determine a participant's propensity for simulation sickness [Freiwald et al., 2020]. The questionnaire asks participants 26 questions The first 13 questions ascertain the general heath and fitness of the subject, and have Yes/No answers The remaining 13 questions are score on a on a 5 point Likert scale, with five point Likert scales, referring to the frequency of each complaint's occurrence. These scales range from 0 to 4 with the labels "very rarely", "rarely", "occasionally", "frequently" and "very often".	Screening at consent (one time)
Montreal Cognitive Assessment (MoCA) to measure level of cognitive impairment	Used at screening post-consent to determine level of cognitive impairment [Nasreddine et al 2005] for participants. The form has a score range from 0 (worst) to 30 (best) - no cognitive impairments. For the participants with early Alzheimer's Disease the form will confirm the participant is in the score range of 19-25.	Screening at consent (one time)
Biosensor readings	Custom biosensors will provide additional data which will be used to gauge levels of cognitive engagement with the tasks performed during the evaluation.	At each of 4 evaluation sessions over 1 month from enrollment
Game difficulty level	Game difficulty level when performing a simulated game task using the experimental system. Levels are 1 (easiest) to 16 (hardest)	At each of 4 evaluation sessions over 1 month from enrollment
Heart rate	Heart rate (Pulse) measured with a medical meter at start and end of each usability evaluation session	Before and after each of 4 evaluation sessions over 1 month from enrollment
Blood pressure (systolic and diastolic)	Blood pressure (Systolic and diastolic) measured with a medical meter before and after each Usability evaluation session.	Before and after each of 4 evaluation sessions over 1 month from enrollment

Collaborators and Investigators

• Sponsor: Bright Cloud International Corp
• Collaborators: National Cancer Institute (NCI); Rutgers, The State University of New Jersey
• Investigators: Principal Investigator: Grigore C Burdea, PhD, Bright Cloud Int'l Corp

Publications and helpful links

Helpful Links

• Description: BCI's corporate site showing therapeutic games used with the device

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2021
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: April 5, 2021
• First Submitted That Met QC Criteria: April 7, 2021
• First Posted (Actual): April 9, 2021

Study Record Updates

• Last Update Posted (Actual): April 28, 2022
• Last Update Submitted That Met QC Criteria: April 27, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: breast cancer; chemotherapy; cognitive impairments
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Neurocognitive Disorders; Cognition Disorders; Drug-Related Side Effects and Adverse Reactions; Cognitive Dysfunction; Chemotherapy-Related Cognitive Impairment
• Other Study ID Numbers: Telerehab CH Usability; R43CA232936 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We will not disclose data on individual participants.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No