VR-based Intervention for Cognitive Restoration

Breast Cancer Clinical Trial

— CHEERS  

Official title:

Virtual Reality-Based Cognitive Intervention for Women With Cognitive Complaints Following Breast Cancer Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05653596
• Other study ID #: ChungnamNU.J1
• Status: Recruiting
• Phase: N/A
• Start date: December 10, 2019
• Est. completion date: July 31, 2025

Study information

• Verified date: February 2024
• Source: Chungnam National University
• Contact: Mi Sook Jung, PhD
• Phone: 82-42-580-8322
• Email: msj713[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to test the efficacy of a nature-based cognitive intervention to restore cognitive function among women treated for breast cancer.

Description:

Cognitive dysfunction is a kind of cluster of commonly reported neurotoxic symptoms following cancer diagnosis and treatment, especially chemotherapy. Our previous studies found that breast cancer patients and survivors had greater difficulties in performing attention, working memory, and executive function tasks and had persistent neural inefficiency of an executive network of the brain than disease and treatment counterparts. The aim of this study is to test the efficacy of a nature-based cognitive intervention to restore cognitive function among women with cognitive complaints after breast cancer treatment. All participants will receive the initial screening to verify their cognitive status and then will be randomly assigned to the experimental or control group. The experimental group will receive a 4-week cognitive intervention by using a VR headset. Each VR content includes 10-12 video scenes with visual and auditory stimuli that were generated from nature.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 31, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 64 Years

Eligibility

Inclusion Criteria:

• Being treated with chemotherapy for breast cancer
• Having affirmative responses to three questions about cognitive problems and their impact on daily performance
• Having FACT-Cog scores of 58 or less
• Having Mini-Cog scores of 3 and higher
• Having the ability to read, understand or respond to questionnaires and cognitive assessment
• Being willing to participate and able to provide written informed consent

Exclusion Criteria:

• Having metastatic breast cancer
• Having Patient Health Questionnaire-2 score of 3 and higher
• Being diagnosed with neurological disorders such as dementia, multiple sclerosis, or traumatic brain injury
• Having epilepsy or seizure
• Having 'quite a bit' or 'extremely' severe level of nausea and vomiting
• Having visual or hearing impairments
• Having other problems that prevent them from wearing the VR headset

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Cognitive Dysfunction
• Virtual Reality

Intervention

Behavioral:
• Virtual reality-based cognitive intervention
This intervention consists of 12 different VR contents that were developed for this trial. Each content includes 10-12 scenes with visual and auditory stimuli generated from nature. Participants will view 3D nature videos using a VR headset for 20 minutes every other day, three times per week for one month.

Locations

Country	Name	City	State
Korea, Republic of	Cognitive Health Education and Research Center	Daejeon

Sponsors (1)

Lead Sponsor	Collaborator
Chungnam National University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Central Nervous System Vital Signs (CNSVS)	The CNSVS will be used to assess global and domain-specific cognitive function	Cognitive function will be assessed at baseline
Primary	Central Nervous System Vital Signs (CNSVS)	The CNSVS will be used to assess global and domain-specific cognitive function	Cognitive function will be assessed at 4 weeks after baseline (immediate post-intervention)
Primary	Central Nervous System Vital Signs (CNSVS)	The CNSVS will be used to assess global and domain-specific cognitive function	Cognitive function will be assessed at 8 weeks after baseline (4 weeks after intervention)
Primary	Functional Assessment of Cancer Therapy-Cognitive	The FACT-Cog will be used to assess self-reported effectiveness in cognitive function	Perceived cognitive function will be assessed at baseline
Primary	Functional Assessment of Cancer Therapy-Cognitive	The FACT-Cog will be used to assess self-reported effectiveness in cognitive function	Perceived cognitive function will be assessed at 4 weeks after baseline (immediate post-intervention)
Primary	Functional Assessment of Cancer Therapy-Cognitive	The FACT-Cog will be used to assess self-reported effectiveness in cognitive function	Perceived cognitive function will be assessed at 8 weeks after baseline (4 weeks after intervention)
Secondary	Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)	The FACIT-F will be used to assess experience and impact of fatigue	Fatigue will will be assessed at baseline, 4 weeks (immediate post-intervention), and 8 weeks (4 weeks after intervention)
Secondary	Patient Health Questionnaire (PHQ)	The PHQ will be used to assess depressed mood	Depression will be assessed at baseline, 4 weeks (immediate post-intervention), and 8 weeks (4 weeks after intervention)
Secondary	Pittsburgh Sleep Quality Index (PSQI)	The PSQI will be used to assess sleep problems	Sleep problems will be assessed at baseline, 4 weeks (immediate post-intervention), and 8 weeks (4 weeks after intervention)
Secondary	Functional Assessment of Cancer Therapy-General (FACT-G)	The FACT-G will be used to assess health-related quality of life	Quality of life will be assessed at baseline, 4 weeks (immediate post-intervention), and 8 weeks (4 weeks after intervention)
Secondary	Perceived Restorativeness for Activities Scale (PRAS)	The PRAS will be used to assess perceived restorativeness of their activities engaged to improve cognition	Perceived restorativeness will be assessed at baseline, 4 weeks (immediate post-intervention), and 8 weeks (4 weeks after intervention)