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Telerehabilitation Cognitive Impairments Following Chemotherapy Usability Study (TCIFCU)

2022年4月27日 更新者: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).

研究概览

地位

完全的

详细说明

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.

研究类型

观察性的

注册 (实际的)

4

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • New Jersey
      • North Brunswick、New Jersey、美国、08902
        • Bright Cloud Int'l Corp
      • North Brunswick、New Jersey、美国、08902
        • New Jersey Bioscience Center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

20年 至 65年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

女性

取样方法

非概率样本

研究人群

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

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
USE questionnaire to assess the usability of a computerized system
大体时间: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)

次要结果测量

结果测量
措施说明
大体时间
Subjective rating questionnaire of the device and therapy
大体时间: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

其他结果措施

结果测量
措施说明
大体时间
Simulation Sickness Questionnaire for participant
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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)
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Grigore C Burdea, PhD、Bright Cloud Int'l Corp

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年6月7日

初级完成 (实际的)

2021年12月31日

研究完成 (实际的)

2021年12月31日

研究注册日期

首次提交

2021年4月5日

首先提交符合 QC 标准的

2021年4月7日

首次发布 (实际的)

2021年4月9日

研究记录更新

最后更新发布 (实际的)

2022年4月28日

上次提交的符合 QC 标准的更新

2022年4月27日

最后验证

2022年4月1日

更多信息

与本研究相关的术语

其他研究编号

  • Telerehab CH Usability
  • R43CA232936 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

IPD 计划说明

We will not disclose data on individual participants.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

Usability study的临床试验

3
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