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Telerehabilitation Cognitive Impairments Following Chemotherapy Usability Study (TCIFCU)

27. dubna 2022 aktualizováno: Bright Cloud International Corp

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).

Přehled studie

Postavení

Dokončeno

Intervence / Léčba

Detailní popis

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.

Typ studie

Pozorovací

Zápis (Aktuální)

4

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

    • New Jersey
      • North Brunswick, New Jersey, Spojené státy, 08902
        • Bright Cloud Int'l Corp
      • North Brunswick, New Jersey, Spojené státy, 08902
        • New Jersey Bioscience Center

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

20 let až 65 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Ženský

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

The targeted subjects will be either breast cancer survivors, living in the community, without requiring transfers, or healthy, age-matched volunteers.

Popis

At NJ Bioscience Center Healthy Volunteers

  • Female
  • Age 20 to 65;
  • Good or corrected hearing;
  • Good or corrected vision;
  • No motor or cognitive impairments;
  • English speakers;
  • Those with low propensity for simulation sickness (as determined by the Simulation Sickness Questionnaire [Kennedy et al, 1993]).
  • Either healthy or having had stage II or stage III breast cancer;
  • Montreal Cognitive Assessment (MoCA) Score 10-25 indicating mild to moderate impairment [Chapman 2016] or 26-30 indicating normal cognition;

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
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;

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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
USE questionnaire to assess the usability of a computerized system
Časové okno: 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.

At the end of the 4th evaluation session (about 1 month from enrollment)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Subjective rating questionnaire of the device and therapy
Časové okno: At each of 4 evaluation sessions over 1 month from enrollment
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

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Simulation Sickness Questionnaire for participant
Časové okno: Screening at consent (one time)
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).
Screening at consent (one time)
Cyber-sickness Susceptibility Questionnaire for participant
Časové okno: Screening at consent (one time)
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
Časové okno: Screening at consent (one time)
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
Časové okno: At each of 4 evaluation sessions over 1 month from enrollment
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
Časové okno: At each of 4 evaluation sessions over 1 month from enrollment
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
Časové okno: Before and after each of 4 evaluation sessions over 1 month from enrollment
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)
Časové okno: Before and after each of 4 evaluation sessions over 1 month from enrollment
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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

  • Vrchní vyšetřovatel: Grigore C Burdea, PhD, Bright Cloud Int'l Corp

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

7. června 2021

Primární dokončení (Aktuální)

31. prosince 2021

Dokončení studie (Aktuální)

31. prosince 2021

Termíny zápisu do studia

První předloženo

5. dubna 2021

První předloženo, které splnilo kritéria kontroly kvality

7. dubna 2021

První zveřejněno (Aktuální)

9. dubna 2021

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

28. dubna 2022

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

27. dubna 2022

Naposledy ověřeno

1. dubna 2022

Více informací

Termíny související s touto studií

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

We will not disclose data on individual participants.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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