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| ID | Type | Description | Link |
|---|---|---|---|
| R43CA232936 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Rutgers, The State University of New Jersey | OTHER |
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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).
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Usability study | 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. |
| 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) |
| 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 |
| 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). |
At NJ Bioscience Center Healthy Volunteers
EXCLUSION CRITERIA
Since the study targets breast cancer survivors, participants will all be female. Breast cancer prevalence is overwhelmingly in women.
The targeted subjects will be either breast cancer survivors, living in the community, without requiring transfers, or healthy, age-matched volunteers.
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| Name | Affiliation | Role |
|---|---|---|
| Grigore C Burdea, PhD | Bright Cloud Int'l Corp | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bright Cloud Int'l Corp | North Brunswick | New Jersey | 08902 | United States | ||
| New Jersey Bioscience Center |
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| Label | URL |
|---|---|
| Description: BCI's corporate site showing therapeutic games used with the device | View source |
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We will not disclose data on individual participants.
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| ID | Term |
|---|---|
| D000084202 | Chemotherapy-Related Cognitive Impairment |
| D060825 | Cognitive Dysfunction |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
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| 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 |
| North Brunswick |
| New Jersey |
| 08902 |
| United States |
| D001523 | Mental Disorders |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |