Clinical trial NCT05653596: VR-based Intervention for Cognitive Restoration
Official title: Virtual Reality-Based Cognitive Intervention for Women With Cognitive Complaints Following Breast Cancer Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Cognitive Dysfunction
Virtual Reality
Lead sponsor: Chungnam National University
Sponsor class: OTHER
First posted: 2022-12-16
Enrollment: 200
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Central Nervous System Vital Signs (CNSVS)
timeFrame: Cognitive function will be assessed at baseline
measure: Central Nervous System Vital Signs (CNSVS)
timeFrame: Cognitive function will be assessed at 4 weeks after baseline (immediate post-intervention)
measure: Central Nervous System Vital Signs (CNSVS)
timeFrame: Cognitive function will be assessed at 8 weeks after baseline (4 weeks after intervention)
measure: Functional Assessment of Cancer Therapy-Cognitive
timeFrame: Perceived cognitive function will be assessed at baseline
measure: Functional Assessment of Cancer Therapy-Cognitive
timeFrame: Perceived cognitive function will be assessed at 4 weeks after baseline (immediate post-intervention)
measure: Functional Assessment of Cancer Therapy-Cognitive
timeFrame: Perceived cognitive function will be assessed at 8 weeks after baseline (4 weeks after intervention)
Secondary outcomes:
measure: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
timeFrame: Fatigue will will be assessed at baseline, 4 weeks (immediate post-intervention), and 8 weeks (4 weeks after intervention)
measure: Patient Health Questionnaire (PHQ)
timeFrame: Depression will be assessed at baseline, 4 weeks (immediate post-intervention), and 8 weeks (4 weeks after intervention)
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Sleep problems will be assessed at baseline, 4 weeks (immediate post-intervention), and 8 weeks (4 weeks after intervention)
measure: Functional Assessment of Cancer Therapy-General (FACT-G)
timeFrame: Quality of life will be assessed at baseline, 4 weeks (immediate post-intervention), and 8 weeks (4 weeks after intervention)
measure: Perceived Restorativeness for Activities Scale (PRAS)
timeFrame: Perceived restorativeness will be assessed at baseline, 4 weeks (immediate post-intervention), and 8 weeks (4 weeks after intervention)
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: Cognitive Health Education and Research Center
Study officials:
affiliation: Chungnam National University
name: Mi Sook Jung, PhD
role: PRINCIPAL_INVESTIGATOR
References: