The Effect of a Virtual Reality-Based Mindfulness Intervention on Anxiety, Comfort, Sleep, and Fatigue in Breast Cancer Patients Undergoing Chemotherapy

NCT07731477 | Recruiting DMC

• 1 other identifier: 2024-12/890
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer; Chemotherapy

Keywords

Breast cancer; chemotherapy; Mindfulness; Virtual Reality

Outcome Measures

Primary Outcomes (5)

• 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.

  Assessed three times: after chemotherapy education and before Cycle 1; after the third virtual reality mindfulness session during Cycle 2; and after the sixth session, 2-3 weeks after Cycle 4. Cycles occur every 14 or 21 days.

• 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.

  Assessed three times: after chemotherapy education and before Cycle 1; after the third virtual reality mindfulness session during Cycle 2; and after the sixth session, 2-3 weeks after Cycle 4. Cycles occur every 14 or 21 days.

• 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.

  Assessed three times: after chemotherapy education and before Cycle 1; after the third virtual reality mindfulness session during Cycle 2; and after the sixth session, 2-3 weeks after Cycle 4. Cycles occur every 14 or 21 days.

• 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.

  Assessed three times: after chemotherapy education and before Cycle 1; after the third virtual reality mindfulness session during Cycle 2; and after the sixth session, 2-3 weeks after Cycle 4. Cycles occur every 14 or 21 days.

• Mindfulness-Based Self-Efficacy Assessed Using the Mindfulness-Based Self-Efficacy Scale-Revised

  Mindfulness-based self-efficacy will be assessed using the 22-item Mindfulness-Based Self-Efficacy Scale-Revised. The mean score ranges from 0 to 4. Higher scores indicate greater mindfulness-based self-efficacy.

  Assessed three times: after chemotherapy education and before Cycle 1; after the third virtual reality mindfulness session during Cycle 2; and after the sixth session, 2-3 weeks after Cycle 4. Cycles occur every 14 or 21 days.

Study Arms (2)

VR-Mindfulness Intervention Group

EXPERIMENTAL

Participants in this group will receive the Virtual Reality-Based Mindfulness program in addition to standard care during chemotherapy sessions.

Behavioral: VR-Based Mindfulness Intervention

Control Group

NO INTERVENTION

Participants in this group will receive standard nursing care and routine chemotherapy without the VR-Mindfulness program.

Interventions

VR-Based Mindfulness Intervention BEHAVIORAL

The 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.

VR-Mindfulness Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Eligibility is limited to individuals who are biologically female because the study focuses on breast cancer patients receiving chemotherapy.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosed with breast cancer, Female and aged 18 years or older, Diagnosed with stage II or III breast cancer, Scheduled to receive chemotherapy for breast cancer for the first time in the adjuvant or neoadjuvant setting, using either the CA regimen \[C: cyclophosphamide; A: doxorubicin (Adriamycin)\] or the TC regimen \[T: docetaxel; C: cyclophosphamide\], with or without paclitaxel, trastuzumab, docetaxel, or carboplatin, Scheduled to receive chemotherapy but have not yet started treatment, Have a Beck Depression Inventory (BDI) score of ≤30, have no physician-diagnosed psychiatric disorder according to the DSM-5 diagnostic criteria, and are not receiving treatment for a psychiatric disorder (Appendix 8), Have completed at least primary school education, Voluntarily agree to participate in the study.

You may not qualify if:

• Presence of metastasis, History of seizures, Presence of vertigo, Presence of motion sickness with a tendency toward nausea and vomiting, Communication difficulties, including hearing, visual, or speech impairments, Unwillingness to participate in the study. Withdrawal Criteria
• Participants will be withdrawn from the study if:
• They discontinue the treatment protocol at any stage, Their treatment protocol is changed, They no longer wish to continue participating in the study.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Dr. Abdurrahman Yurtaslan Ankara Oncology Hospital, Ministry of Health, Republic of Turkey

Ankara, Ankara, 06830, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

GİZEM CANSIZ UÇAR, Registered Nurse

CONTACT

+905342396480; gizem.cansiz@atilim.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This study is a randomized controlled trial with a parallel assignment model. Participants will be randomly assigned to either the intervention group, which will receive a virtual reality-based mindfulness intervention during chemotherapy, or the control group, which will receive routine care. Outcomes will be assessed at baseline, during the intervention period, and at follow-up.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Registered Nurse

Model Details: This study is designed as a randomized controlled trial with a parallel assignment model. Participants will be randomly assigned to either the intervention group, which will receive a Virtual Reality-Based Mindfulness program during chemotherapy sessions, or the control group, which will receive standard care. Outcomes will be assessed before, during, and after the intervention period

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 28, 2026
• Study Start: October 1, 2025
• Primary Completion: July 1, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)