Telerehabilitation Cognitive Impairments Following Chemotherapy Usability Study

Healthy Clinical Trial

— TCIFCU  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04839588
• Other study ID #: Telerehab CH Usability
• Secondary ID: R43CA232936
• Status: Completed
• Start date: June 7, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: April 2022
• Source: Bright Cloud International Corp
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chemotherapy-Related Cognitive Impairment
• Cognitive Dysfunction
• Healthy

Intervention

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.

Locations

Country	Name	City	State
United States	Bright Cloud Int'l Corp	North Brunswick	New Jersey
United States	New Jersey Bioscience Center	North Brunswick	New Jersey

Sponsors (3)

Lead Sponsor	Collaborator
Bright Cloud International Corp	National Cancer Institute (NCI), Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Other	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)
Other	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
Other	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
Other	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
Other	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
Primary	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	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

External Links

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