Telerehabilitation Cognitive Impairments Following Chemotherapy Feasibility Study

NCT04972019 | Unknown DMC

• 2 other identifiers: Telerehab CH FeasibilityR43CA232936
• Study Type: interventional
• Target: 40
• 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 on a wearable device enhanced with biosensors. Participants are stage II and stage III breast cancer survivors with lasting cognitive impairments following their first round of chemotherapy. They will be randomized 1:1 into an experimental group and a sham control group. Each group will train in the home for 8 weeks, during which they will perform up to 4 rehabilitation sessions/week (based on tolerance). Each session will start with vitals being measured and logged. Each group will have three clinical evaluations: 1) at baseline; 2) at 8 weeks post-baseline; and 3) at 16 weeks from baseline for follow up. Experimental group sessions will consist of increasingly more difficult cognitive training tasks in the form of simulated tasks. Biosensors will be sampled while participants interact with these games while wearing the computer system. Sham control group will have the same number, suration and frequency of sessions, however they will play web games while wearing some the same biosensors. Caregivers of all subjects will receive a laptop to be used in filling subjective evaluation forms and sending messages to research team. Training will be in the home, so caregivers will need to support the trials by ensuring compliance with the protocol. All subjects will undergo standardized clinical evaluations at baseline, at 8 weeks and at 16 weeks from baseline. The subjects in the experimental group will have computerized measures taken during each session, and will fill subjective evaluation forms every 4 weeks of active training.

Conditions

Cognitive Impairment, Mild

Keywords

chemotherapy; cognitive impairments; breast cancer; executive functions

Outcome Measures

Primary Outcomes (7)

• Change in Montreal Cognitive Assessment (MoCA)

  Measure of change in cognitive impairment for cancer survivors and their caregivers

  Change from Screening at baseline, to 8 weeks and to 16 weeks from baseline

• Change in Test of Pre-morbid Functioning

  Measure cognitive ability \[Pearson Education 2017\]

  Change from baseline, to 8 weeks and to 16 weeks from baseline

• Change in NAB Attention Module

  Measure of sustained attention \[Hartman 2006\]

  Change from baseline, to 8 weeks and to 16 weeks from baseline

• Change in NAB Functioning Word Module

  Measure of word generation \[White and Stern 2003\]

  Change from baseline, to 8 weeks and to 16 weeks from baseline

• Change in Trail Making Test

  A measure of executive functioning \[Raitan 1958\]

  Change from baseline, to 8 weeks and to 16 weeks from baseline

• Change in Hopkins Verbal Learning Test Revised

  Verbal/auditory memory test \[Brandt 1991\];

  Change from baseline, to 8 weeks and to 16 weeks from baseline

• Change in Brief Visuo-spatial Memory Test, Revised (BVMT-R)

  Visual memory test \[Benedict et al., 1996\];

  Change from baseline, to 8 weeks and to 16 weeks from baseline

Secondary Outcomes (12)

• Change in Quality of Life Patient/Cancer Survivor Version (QOL-CSV)

  Change from baseline, to 8 weeks and to 16 weeks from baseline

• Caregiver Quality of Life-Cancer (CQOL-C)

  Change from baseline, to 8 weeks and to 16 weeks from baseline

• Change in Beck Depression Inventory II

  Change from baseline, to 8 weeks and to 16 weeks from baseline

• Change in Grasp strength (Jamar dynamometer)

  Change from baseline to 8 weeks and to 16 weeks from baseline

• Change in Shoulder strength (wrist weights)

  Change from baseline, to 8 weeks and to 16 weeks from baseline

Other Outcomes (3)

• Cyber-sickness Susceptibility Questionnaire for participant

  Screening at consent

• Change in Heart rate

  Change in heart rate from baseline to end of 8 week trainig measured every session.

• Change in Blood pressure (systolic and diastolic)

  Change in heart rate from baseline to end of 8 week trainig measured every session.

Study Arms (2)

Telerehabilitation experimental group

EXPERIMENTAL

Experimental training will occur in the home. The experimental training will last 8 weeks, each week having up to 4 sessions of therapeutic game play (based on tolerance). Each session will start with vitals being measured and logged. Data will be uploaded on a secure cloud server to which clinicians will have access.

Device: Telerehabilitation Experimental Group

Telerehabilitation control group

SHAM COMPARATOR

Participants will perform web-based game play while wearing sham equipment. Duration of sessions will be fixed and frequency of sessions will equal that of the experimental group training. Over the total training the control group will have an equal duration of training with the experimental group.

Other: Telerehabilitation Sham Control Group

Interventions

Telerehabilitation Experimental Group DEVICE

Experimental training will occur in the home. The experimental training will last 8 weeks, each week having up to 4 sessions of therapeutic game play (based on tolerance). Each session will start with vitals and subjective pain level being measured and logged. They will wear a computer system modified with biosensors, then do motor and cognitive baselines. Subsequently, participants will play an increasing number of games, targeted at cognitive domains of executive function (primary), memory and attention. At the end of every session vitals and subjective pain will be measured and logged. Clinical Coordinator will call homes weekly to ascertain general health and issues with participation. At the end of week 4 and 8 participants and their caregivers in the experimental group will fill a subjective evaluation questionnaire to gauge perceived benefits and technical difficulties when using the experimental system. Questions will be scored on a 5-point Likert scale.

Telerehabilitation experimental group

Telerehabilitation Sham Control Group OTHER

Sham control group will train playing web games while wearing a biosensor connected to a laptop provided, showing the web games. However biosensor data will not be used to control game difficulty. Sham group controls will start every session with vitals and subjective pain levels being measured and logged. Then participants will play the same frequency and duration of sessions, however those will consist of web games training the same domains (memory, focusing, executive function). Interaction will be through a mouse, and data will be downloaded to a server maintained by the company doing the web games. Data will then be transferred to the research team. At the end of every session vitals and subjective pain levels will again be measured and logged. Once a week the Clinical Coordinator will call the home to ascertain general health and determine is there were issues with that week participation.

Telerehabilitation control group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Gender Eligibility Details: Only female will be recruited, as this study targets breast cancer survivors.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female breast cancer survivor;
• Age 20 to 65 years;
• At least 12 years of formal education;
• Not participating in other studies;
• Generally healthy and active pre-diagnosis (based on self-report);
• Chemotherapy related cognitive impairments with a Montreal Cognitive Assessment (MoCA) Score 10-25 indicating mild to moderate impairment \[Chapman 2016\];
• Having had invasive (Stages II and III) breast cancer;
• Had completed standard course of chemotherapy with Anthracyclines: doxorubicin (Adriamycin) \& epirubicin (Ellence), or Taxanes: docetalex (Taxotere) \& paclitaxel (Taxol), or Combination therapies with like carboplatin, cyclophosphamide (Cytoxan), and fluorouracil (5-FU).
• At least one month post completion of first chemotherapy regimen.
• English speakers so as to comprehend game instructions, feedback forms, clinical exam questionnaires, and neuropsychological testing;
• Adult caregivers male or female can be either spouse, child, or a significant other living in the same home and available for the study;
• Absence of lymphedema or other co-morbidity limiting upper extremity function;
• Low propensity for simulation sickness (as measured by Simulation Sickness questionnaire);
• Living in the community in Central Jersey so to facilitate researchers travel to home for system installation and/or repairs,
• Living with a caregiver willing to support trials and be present during sessions;

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)

Rutgers University Rober Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

RECRUITING

Bright Cloud Int'l Corp

North Brunswick, New Jersey, 08902, United States

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction; Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Grigore C Burdea, PhD

CONTACT

908409334; diplomatru@yahoo.com

Edward A Burde, MS

CONTACT

7326400400; ed@brightcloud.health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes Assessor will not be told which group the participant is part of, so not be biased in evaluations.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Feasibility Sham comparison study: Participants are randomized equally into the experimental group and a sham control group. Randomization will be based on a randomization table prepared by a contracted bio-statistician.

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: July 22, 2021
• Study Start: February 9, 2022
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: May 2, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: After completion of study

Locations

US (2)