Telerehabilitation Cognitive Impairments Following Chemotherapy Usability Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-07

Study Completion Date

2021-12-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Chemotherapy-Related Cognitive Impairment Healthy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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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;

Usability study

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes