About this trial
Breast cancer is a public health issue with a high incidence among women worldwide, and its prevalence continues to increase each year. A breast cancer diagnosis brings significant physical, emotional, social, economic, and occupational changes. Chemotherapy, one of the most commonly used treatment modalities in cancer therapy, causes various physical and emotional symptoms while treating the disease. However, it is well known that these symptoms induced by chemotherapy can be prevented or alleviated through effective treatment and nursing interventions.
Recently, virtual reality (VR) and mindfulness-based interventions have been reported as effective tools and methods for managing the physical and psychological symptoms experienced by cancer patients.
The present study aims to evaluate the effect of a VR-integrated mindfulness-based intervention on anxiety, comfort, sleep, and fatigue levels among women newly diagnosed with breast cancer, both before and during chemotherapy treatment. The study is designed as a randomized controlled trial (RCT).
The study population will consist of individuals diagnosed with breast cancer at the Oncology Outpatient Clinic of Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital between May 2025 and December 2026. The study sample will include female breast cancer patients who are scheduled to receive adjuvant chemotherapy, meet the inclusion criteria, and volunteer to participate in the study.
According to the power analysis (with a 30% additional error margin), a total of 50 participants will be included - 25 in the intervention group and 25 in the control group.
The data will be collected using the following instruments: Patient Information Form, Beck Depression Inventory, Cancer Fatigue Scale, General Comfort Questionnaire-Short Form, State Anxiety Inventory, Jenkins Sleep Scale, and the Mindfulness-Based Self-Efficacy Scale.
It is expected that, as a result of this study, compared to the control group, participants in the intervention group who receive the VR-Mindfulness intervention during breast cancer treatment will demonstrate reduced levels of fatigue and anxiety and improved comfort and sleep quality.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
VR-Based Mindfulness Intervention
BehavioralThe mindfulness intervention content was developed collaboratively by the research team and a mindfulness expert, based on a literature-informed design tailored to the study's aims and target population. Among the researchers, GCU has completed training in Mindfulness-Based Stress Reduction (MBSR), simulation-based practice, and has prior experience working with breast cancer patients. The mindfulness expert (EU), a licensed medical doctor, holds certifications in Mindfulness Teaching (Bangor University, UK), Professional Coaching (CTI), and the Mindfulness in Schools Project (UK). To align with the study objectives, mindfulness contents addressing anxiety, comfort, sleep, and fatigue were created by the team and the expert.
Treatment groups
Trial outcomes
Primary outcomes
Fatigue Assessed Using the Cancer Fatigue Scale
Fatigue will be assessed using the Cancer Fatigue Scale. The 15-item scale produces a total score ranging from 0 to 60. Higher scores indicate greater fatigue severity.
Comfort Assessed Using the General Comfort Questionnaire-Short Form
Comfort will be assessed using the General Comfort Questionnaire-Short Form. The 28-item scale produces a total score ranging from 28 to 168. Higher scores indicate a higher level of comfort.
Sleep Quality Assessed Using the Jenkins Sleep Scale
Sleep quality will be assessed using the Jenkins Sleep Scale. The four-item scale produces a total score ranging from 0 to 20. Higher scores indicate more frequent sleep problems and poorer sleep quality.
Anxiety Assessed Using the State-Trait Anxiety Inventory-State Anxiety Subscale
Anxiety will be assessed using the State Anxiety subscale of the State-Trait Anxiety Inventory. The 20-item subscale produces a total score ranging from 20 to 80. Higher scores indicate greater state anxiety.
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