Cognition Assessment and REhabilitation in Virtual Reality for Patients With Cancer (CARE-VR4PC)

Cognition Assessment and REhabilitation in Virtual Reality for Patients With Cancer (CARE-VR4PC)

1. To assess the cognitive function of patients with cancer by leveraging a validated virtual reality (VR)-based cognitive assessment tool.
2. 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Patients With Cancer
• Intervention / Treatment: Behavioral: VR-based cognitive rehabilitation therapy (VR-CRT)

Detailed Description

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.

After confirmation of the above criteria, the patient will undergo a 1-hour hands-on training session at the cancer center by trained study team members.

A set of training slides titled "VR-CRT User Training Slides" that is adapted from the standard "VR-CRT Instruction Manual" will be utilized for the training session for the patient. After which, a checklist titled "VR Training Checklist" will be completed by both the trainer and patient. This checklist is aimed to ensure that all necessary components of training have been covered by the trainer and also for trainers to indicate confidence of the patient during the training before both trainer and patient sign as a form of training acknowledgement.

Post training, a copy of the standard "VR-CRT Instruction Manual" will be given to the patient. Study team will emphasize to the patient that they can contact the study team at any juncture where they need additional clarifications relating to the device.

Depending on the treatment status at time of screening, the patient will be seen in the inpatient ward or specialist outpatient clinic at day 14 which is considered as Visit 2 (Randomization with allowance + 3 days). Allowance of up to 3 days is given in the event day 14 falls on a weekend/long weekend. Following Visit 2 (Randomization with allowance + 3 days), up to 3 days of habituation for VR device use and tolerability will take place. Participants will be required to engage with the VR device at low levels of immersion to allow conditioning for the habituation period. Because of the nature of the intervention, it may cause some discomfort to the participants, such as mild cybersickness, hence conditioning will increase the tolerability of the treatment for the participants.

Intervention with VR-CRT will take place over 8 weeks either in the inpatient setting of the cancer center or in the home setting, while standard oncology supportive care sessions happening concurrently as per existing clinical treatment protocol. Treatment with VR-CRT will consist of a daily session of 30-45 minutes for 24 sessions over 8 weeks (3 sessions per week). Compliance will be checked by research assistant via telephone or video call interview at regular intervals. One group will be randomized to the standard care (Control) arm and one group will be randomized to the active VR-CRT intervention arm. The standard care (Control) arm will involve routine oncology follow-up and educational resources on cognitive symptom management but no active VR engagement, with assessments conducted in a comparable manner to maintain blinding.

Assessment will be done at the time of recruitment which constitutes as Visit 1 (Recruitment), and again at Visit 3 (Last day of intervention, Week 8 post-intervention with allowance of + 7 days) and Visit 4 (Final follow-up, Week 20 post-intervention with allowance of + 7 days).

Management of adverse events (AEs and SAEs):

At recruitment, patients will be informed to take note and save research coordinator's contact number stated in the informed consent form (ICF). Patients will be reminded to contact research coordinators if patients experience any AE/SAE stated on ICF section 6 from the day of recruitment up to randomization. At randomization it will again be emphasized to patients that they are to continue to monitor for AE/SAE. During the duration of habituation through to the 8-week intervention period, patients are additionally required to report to the study coordinators with regards to any discomfort or issues with the device before proceeding with intervention. During the habituation and the 8-week intervention period, study coordinator will be keeping close contact with the patient by means of messaging apps to ensure compliance to the treatment regime and for AE/SAE reporting.

Patients who are starting the intervention in the inpatient setting will be monitored by the study team for any adverse events.

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Leonard Yeo; Phone Number: +65 8446 0373; Email: chloezengyc@hotmail.co.uk
• Study Contact Backup: Name: Yu Yang Soon; Phone Number: +65 81092059; Email: chloezengyc@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• (1) Cancer (both Solid and haematological) patients with documented cognitive impairments. (2) No history of neurological disorders. (3) Ability to use VR technology.

Exclusion Criteria:

• Severe visual or auditory impairments, motion sickness, or conditions interfering with VR use.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VR-based cognitive rehabilitation therapy (VR-CRT); Intervention Arm	Behavioral: VR-based cognitive rehabilitation therapy (VR-CRT); 12 VR-CRT sessions over 4 weeks, with sessions occurring 3 times per week, targeting attention, memory, and executive function
No Intervention: Standard Care only; Control arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VR Cognition Assessment Tool	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).	From enrollment to Day 90 post-intervention (with allowance of + 7 days).
Subjective cognitive function by FACT-Cog	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).	From enrollment to Day 90 post-intervention (with allowance of + 7 days).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EQ5D-5L	Effects of VR-based cognitive rehabilitation therapy (VR-CRT) compared to standard care only (Control) on quality of life (QOL) measured objectively using EQ5D-5L. Mean change in EQ5D-5L 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).	From enrollment to Day 90 post intervention (with allowance of + 7 days).
Virtual Reality Simulation Sickness Questionnaire (VRSQ)	Effects of VR-based cognitive rehabilitation therapy (VR-CRT) compared to standard care only (Control) on simulation sickness measured objectively using Virtual Reality Simulation Sickness Questionnaire (VRSQ). Mean change in VRSQ 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).	From enrollment to Day 90 post-intervention (with allowance of + 7 days).
User-friendliness and engagement	Effects of VR-based cognitive rehabilitation therapy (VR-CRT) compared to standard care only (Control) on From enrollment to Day 90 post-intervention (with allowance of + 7 days). assessed using a 9-item scale developed from Makransky and Lilleholt. Mean change in the 9-item scale 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).	From enrollment to Day 90 post-intervention (with allowance of + 7 days).
Treatment satisfaction by VAS	Effects of VR-based cognitive rehabilitation therapy (VR-CRT) compared to standard care only (Control) on treatment satisfaction measured using Visual Analog Scale (VAS). Mean change in VAS 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)	From enrollment to Day 90 post-intervention (with allowance of + 7 days)

Collaborators and Investigators

• Sponsor: JING MINGXUE
• Collaborators: National University of Singapore
• Investigators: Principal Investigator: Yingchun Zeng, National University of Singapore

Publications and helpful links

General Publications

• Zeng Y, Guan Q, Su Y, Huang Q, Zhao J, Wu M, Guo Q, Lyu Q, Zhuang Y, Cheng AS. A self-administered immersive virtual reality tool for assessing cognitive impairment in patients with cancer. Asia Pac J Oncol Nurs. 2023 Feb 28;10(3):100205. doi: 10.1016/j.apjon.2023.100205. eCollection 2023 Mar.
• Zeng Y, Zeng L, Cheng ASK, Wei X, Wang B, Jiang J, Zhou J. The use of immersive virtual reality for cancer-related cognitive impairment assessment and rehabilitation: A clinical feasibility study. Asia Pac J Oncol Nurs. 2022 May 17;9(12):100079. doi: 10.1016/j.apjon.2022.100079. eCollection 2022 Dec.

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: December 30, 2025
• First Submitted That Met QC Criteria: January 5, 2026
• First Posted (Actual): January 13, 2026

Study Record Updates

• Last Update Posted (Actual): January 13, 2026
• Last Update Submitted That Met QC Criteria: January 5, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Cancer; Quality of Life; Virtual Reality; Cancer-related cognitive impairment; Cognitive Rehabilitation Therapy
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 2025-0993; NUSSUG2025 (Other Grant/Funding Number: National University of Singapore Start-up Grant)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all IPD that underlie results in a publication
• IPD Sharing Time Frame: Beginning 6 months and ending 1 years after the publication of results
• IPD Sharing Access Criteria: Analyses that qualify for data sharing: meta-analysis Data sharing agreement needs to be signed. Applicant can email the study's Principal Investigator to submit request.
• IPD Sharing Supporting Information Type: ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No