Cognition Assessment and REhabilitation in Virtual Reality for Patients With Cancer (CARE-VR4PC)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 主要终点
- VR Cognition Assessment Tool
研究概览
简要总结
- To assess the cognitive function of patients with cancer by leveraging a validated virtual reality (VR)-based cognitive assessment tool.
- To evaluate the efficacy of VR-based cognitive rehabilitation therapy (VR-CRT) compared to a control group in improving cognitive functions in cancer patients.
Hypothesis
Cancer patients with cancer-related cognitive impairment who receive the VR-CRT program will demonstrate significantly greater improvement in cognitive functions, as measured by the validated VR cognition assessment tool, compared to those who receive standard care, both immediately post-intervention and at 3-month follow-up.
详细描述
In this prospective, assessor-blinded, randomized controlled study, a total of 64 participants with cancer-related cognitive impairment will be recruited from oncology inpatient wards and outpatient clinics at a tertiary cancer center. 32 participants will be randomized to the intervention arm (VR-based cognitive rehabilitation therapy [VR-CRT]) and 32 participants will be randomized to the control arm (standard care).
The study will consist of a screening period of up to 14 days. Participants who fulfill all inclusion criteria will be consented and recruited during this screening period, constituting Visit 1 (Recruitment). During this visit, the principal investigator (PI) or co-investigator (Co-I) obtaining consent will ensure that the patient meets the following criteria:
For patients where a caregiver may assist with VR setup or monitoring, the study team will ensure that they are the primary caregiver of the patient.
Patient must be comfortable and committed to following directions for VR device usage.
Patient must not have severe cognitive or sensory impairments that preclude safe VR engagement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) Cancer (both Solid and haematological) patients with documented cognitive impairments. (2) No history of neurological disorders. (3) Ability to use VR technology.
排除标准
- •Severe visual or auditory impairments, motion sickness, or conditions interfering with VR use.
研究组 & 干预措施
VR-based cognitive rehabilitation therapy (VR-CRT)
Intervention Arm
干预措施: VR-based cognitive rehabilitation therapy (VR-CRT) (Behavioral)
Standard Care only
Control arm
结局指标
主要结局
VR Cognition Assessment Tool
时间窗: From enrollment to Day 90 post-intervention (with allowance of + 7 days).
Effects of VR-based cognitive rehabilitation therapy (VR-CRT) compared to standard care only (Control) on cognitive function measured objectively using VR Cognition Assessment Tool. Mean change in VR Cognition Assessment Tool from Visit 1 (Recruitment) to Visit 2 (Last day of intervention), and Visit 3 (Final follow-up, Day 90 post-intervention with allowance of + 7 days).
Subjective cognitive function by FACT-Cog
时间窗: From enrollment to Day 90 post-intervention (with allowance of + 7 days).
Effects of VR-based cognitive rehabilitation therapy (VR-CRT) compared to standard care only (Control) on subjective cognitive function measured using Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog). Mean change in FACT-Cog from Visit 1 (Recruitment) to Visit 2 (Last day of intervention), and Visit 3 (Final follow-up, Day 90 post-intervention with allowance of + 7 days).
次要结局
- EQ5D-5L(From enrollment to Day 90 post intervention (with allowance of + 7 days).)
- Virtual Reality Simulation Sickness Questionnaire (VRSQ)(From enrollment to Day 90 post-intervention (with allowance of + 7 days).)
- User-friendliness and engagement(From enrollment to Day 90 post-intervention (with allowance of + 7 days).)
- Treatment satisfaction by VAS(From enrollment to Day 90 post-intervention (with allowance of + 7 days))
研究者
JING MINGXUE
Dr
National University Health System, Singapore