Telerehabilitation Cognitive Impairments Following Chemotherapy Usability Study

NCT04839588 | Completed DMC

• 2 other identifiers: Telerehab CH UsabilityR43CA232936
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Chemotherapy-Related Cognitive Impairment; Healthy

Keywords

chemotherapy; cognitive impairments; breast cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Subjective rating questionnaire of the device and therapy

  At each of 4 evaluation sessions over 1 month from enrollment

Other Outcomes (7)

• Simulation Sickness Questionnaire for participant

  Screening at consent (one time)

• Cyber-sickness Susceptibility Questionnaire for participant

  Screening at consent (one time)

• Montreal Cognitive Assessment (MoCA) to measure level of cognitive impairment

  Screening at consent (one time)

Study Arms (1)

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

Interventions

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.

Usability study, healthy volunteers and those with cognitive impairments following chemotherapy

Eligibility Criteria

• Age: 20 Years - 65 Years
• Gender Eligibility Details: Since the study targets breast cancer survivors, participants will all be female. Breast cancer prevalence is overwhelmingly in women.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Bright Cloud International Corp: lead
• National Cancer Institute (NCI): collaborator
• Rutgers, The State University of New Jersey: collaborator

Study Sites (2)

Bright Cloud Int'l Corp

North Brunswick, New Jersey, 08902, United States

Location

New Jersey Bioscience Center

North Brunswick, New Jersey, 08902, United States

Location

Related Links

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

MeSH Terms

Conditions

Chemotherapy-Related Cognitive Impairment; Cognitive Dysfunction; Breast Neoplasms

Condition Hierarchy (Ancestors)

Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Grigore C Burdea, PhD

  Bright Cloud Int'l Corp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2021
• First Posted: April 9, 2021
• Study Start: June 7, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: April 28, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)