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VR-based Intervention for Cognitive Restoration (CHEERS)

Primary Purpose

Breast Cancer, Cognitive Dysfunction, Virtual Reality

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Virtual reality-based cognitive intervention
Sponsored by
Chungnam National University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer

Eligibility Criteria

19 Years - 64 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Cognitive Health Education and Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental: VR restorative intervention

Control: Usual care

Arm Description

Individuals who are assigned to the experimental group will receive a 4-week VR-based cognitive intervention.

Individuals who are assigned to the control group will receive the usual care and then receive the same intervention as they wish.

Outcomes

Primary Outcome Measures

Central Nervous System Vital Signs (CNSVS)
The CNSVS will be used to assess global and domain-specific cognitive function
Central Nervous System Vital Signs (CNSVS)
The CNSVS will be used to assess global and domain-specific cognitive function
Central Nervous System Vital Signs (CNSVS)
The CNSVS will be used to assess global and domain-specific cognitive function
Functional Assessment of Cancer Therapy-Cognitive
The FACT-Cog will be used to assess self-reported effectiveness in cognitive function
Functional Assessment of Cancer Therapy-Cognitive
The FACT-Cog will be used to assess self-reported effectiveness in cognitive function
Functional Assessment of Cancer Therapy-Cognitive
The FACT-Cog will be used to assess self-reported effectiveness in cognitive function

Secondary Outcome Measures

Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
The FACIT-F will be used to assess experience and impact of fatigue
Patient Health Questionnaire (PHQ)
The PHQ will be used to assess depressed mood
Pittsburgh Sleep Quality Index (PSQI)
The PSQI will be used to assess sleep problems
Functional Assessment of Cancer Therapy-General (FACT-G)
The FACT-G will be used to assess health-related quality of life
Perceived Restorativeness for Activities Scale (PRAS)
The PRAS will be used to assess perceived restorativeness of their activities engaged to improve cognition

Full Information

First Posted
December 7, 2022
Last Updated
December 14, 2022
Sponsor
Chungnam National University
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1. Study Identification

Unique Protocol Identification Number
NCT05653596
Brief Title
VR-based Intervention for Cognitive Restoration
Acronym
CHEERS
Official Title
Virtual Reality-Based Cognitive Intervention for Women With Cognitive Complaints Following Breast Cancer Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 10, 2019 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chungnam National University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Cognitive Dysfunction, Virtual Reality

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: VR restorative intervention
Arm Type
Experimental
Arm Description
Individuals who are assigned to the experimental group will receive a 4-week VR-based cognitive intervention.
Arm Title
Control: Usual care
Arm Type
No Intervention
Arm Description
Individuals who are assigned to the control group will receive the usual care and then receive the same intervention as they wish.
Intervention Type
Behavioral
Intervention Name(s)
Virtual reality-based cognitive intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Central Nervous System Vital Signs (CNSVS)
Description
The CNSVS will be used to assess global and domain-specific cognitive function
Time Frame
Cognitive function will be assessed at baseline
Title
Central Nervous System Vital Signs (CNSVS)
Description
The CNSVS will be used to assess global and domain-specific cognitive function
Time Frame
Cognitive function will be assessed at 4 weeks after baseline (immediate post-intervention)
Title
Central Nervous System Vital Signs (CNSVS)
Description
The CNSVS will be used to assess global and domain-specific cognitive function
Time Frame
Cognitive function will be assessed at 8 weeks after baseline (4 weeks after intervention)
Title
Functional Assessment of Cancer Therapy-Cognitive
Description
The FACT-Cog will be used to assess self-reported effectiveness in cognitive function
Time Frame
Perceived cognitive function will be assessed at baseline
Title
Functional Assessment of Cancer Therapy-Cognitive
Description
The FACT-Cog will be used to assess self-reported effectiveness in cognitive function
Time Frame
Perceived cognitive function will be assessed at 4 weeks after baseline (immediate post-intervention)
Title
Functional Assessment of Cancer Therapy-Cognitive
Description
The FACT-Cog will be used to assess self-reported effectiveness in cognitive function
Time Frame
Perceived cognitive function will be assessed at 8 weeks after baseline (4 weeks after intervention)
Secondary Outcome Measure Information:
Title
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
Description
The FACIT-F will be used to assess experience and impact of fatigue
Time Frame
Fatigue will will be assessed at baseline, 4 weeks (immediate post-intervention), and 8 weeks (4 weeks after intervention)
Title
Patient Health Questionnaire (PHQ)
Description
The PHQ will be used to assess depressed mood
Time Frame
Depression will be assessed at baseline, 4 weeks (immediate post-intervention), and 8 weeks (4 weeks after intervention)
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
The PSQI will be used to assess sleep problems
Time Frame
Sleep problems will be assessed at baseline, 4 weeks (immediate post-intervention), and 8 weeks (4 weeks after intervention)
Title
Functional Assessment of Cancer Therapy-General (FACT-G)
Description
The FACT-G will be used to assess health-related quality of life
Time Frame
Quality of life will be assessed at baseline, 4 weeks (immediate post-intervention), and 8 weeks (4 weeks after intervention)
Title
Perceived Restorativeness for Activities Scale (PRAS)
Description
The PRAS will be used to assess perceived restorativeness of their activities engaged to improve cognition
Time Frame
Perceived restorativeness will be assessed at baseline, 4 weeks (immediate post-intervention), and 8 weeks (4 weeks after intervention)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mi Sook Jung, PhD
Phone
82-42-580-8322
Email
msj713@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mi Sook Jung, PhD
Organizational Affiliation
Chungnam National University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cognitive Health Education and Research Center
City
Daejeon
ZIP/Postal Code
48105
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kyeongin Cha, PhDc
Phone
82-42-580-8413
Email
kyeongincha@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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VR-based Intervention for Cognitive Restoration

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