Chemotherapy-Related Cognitive ImpairmentTCIFCUNCT04839588
Telerehabilitation Cognitive Impairments Following Chemotherapy Usability Study
An observational study of Chemotherapy-Related Cognitive Impairment and Healthy, run by Bright Cloud International Corp at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Chemotherapy-Related Cognitive Impairment, Healthy
- What is being tested?
- Usability study
- How many people
- 4 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Jun 2021to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The targeted subjects will be either breast cancer survivors, living in the community, without requiring transfers, or healthy, age-matched volunteers.
Who may be able to join
None listed.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Bright Cloud Int'l Corp
North Brunswick, New Jersey, 08902
New Jersey Bioscience Center
North Brunswick, New Jersey, 08902
About this study
Official title: 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).
Read the 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:
- testing of a added biosensors, new technology acceptance and ease of use at home by these individuals;
- 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
- Chemotherapy-Related Cognitive Impairment, Healthy
- Being tested
- Usability study
- Keywords
- chemotherapy, cognitive impairments, breast cancer
- Medical subject headings
- Chemotherapy-Related Cognitive Impairment, Cognitive Dysfunction, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usability studyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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; Receives: Other: Usability study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the end of the 4th evaluation session (about 1 month from enrollment)
Secondary outcomes (1)
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).
Measured: At each of 4 evaluation sessions over 1 month from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start7 Jun 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-Related Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bright Cloud International Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI), Rutgers, The State University of New Jersey
- Responsible party
- Sponsor
- Investigators
- Grigore C Burdea, PhD, Principal investigator, Bright Cloud Int'l Corp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04839588
- Sponsor's protocol ID
- Telerehab CH Usability
- Other IDs
- R43CA232936
- Acronym
- TCIFCU
- Status last verified
- Apr 2022
- First submitted
- 5 Apr 2021
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will not disclose data on individual participants.
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-based Virtual Reality System for the Treatment of Chemotherapy-related Cognitive Impairments
- ClinicalTrials.gov ID
- NCT04839588
- Acronym / sponsor ID
- TCIFCU / Telerehab CH Usability
- Conditions
- Chemotherapy-Related Cognitive Impairment, Healthy
- Keywords
- chemotherapy, cognitive impairments, breast cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Bright Cloud International CorpIndustry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI), Rutgers, The State University of New Jersey
- Study start
- 7 Jun 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 9 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- testing of a added biosensors, new technology acceptance and ease of use at home by these individuals;
- 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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Usability study, healthy volunteers and those with cognitive impairments following chemotherapy | – | Other: Usability study2 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; |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The targeted subjects will be either breast cancer survivors, living in the community, without requiring transfers, or healthy, age-matched volunteers.
Key inclusion criteria (0 listed)
Key exclusion criteria (20 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usability studyParticipants 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. | Other | Usability study, healthy volunteers and those with cognitive impairments following chemotherapy |
Primary outcome
USE questionnaire to assess the usability of a computerized system
Time frame: At the end of the 4th evaluation session (about 1 month from enrollment)
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.
1 secondary outcome
Subjective rating questionnaire of the device and therapy
Time frame: At each of 4 evaluation sessions over 1 month from enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
- Description: BCI's corporate site showing therapeutic games used with the deviceLink provided by the sponsor.
- Individual participant dataSharing planned: No. We will not disclose data on individual participants.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grigore C Burdea, PhD principal investigator
Bright Cloud Int'l Corp
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chemotherapy-Related Cognitive Impairment and Healthy, run by Bright Cloud International Corp at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
USE questionnaire to assess the usability of a computerized system (time frame: At the end of the 4th evaluation session (about 1 month from enrollment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2022.