Clinical trial NCT06863623: The Effect of Immersive Virtual Reality and Relaxing Videos on Lung Cancer Patients
Official title: The Effect of Immersive Virtual Reality and Relaxing Videos on Symptom Severity, Distress and Quality of Life in Patients With Lung Cancer Undergoing Chemotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer
Chemotherapy Effect
Distress, Emotional
Quality of Life (QOL)
Keywords: cancer
chemotherapy
immersive
virtual reality
lung cancer
quality of life
symptom
side-effect
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2025-03-07
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three-Arm Randomised Controlled Trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: Lung cancer is one of the types of cancer with a high incidence and mortality rate in the world and in our country. Frequently used protocols in the chemotherapy treatment of lung cancer are the Platine-based drugs. The main side effects of this chemotherapy protocols are nausea, vomiting, neutropenia and fatigue. The side effects of cancer and chemotherapy cause patients to experience distress and their quality of life is adversely affected. Some non-pharmacological methods such as meditation, breathing exercises, and massage can be used to manage the symptoms experienced by patients due to chemotherapy for supportive care. One of these methods is the virtual reality applications. In addition, audio-visual (video) therapy methods are other methods that can be used in the symptom management of these patients. In this study, the effect of interactive/imersive virtual reality intervention and relaxant video intervention on symptom severity, distress level and quality of life of patients diagnosed with lung cancer will be evaluated. Patients will be assigned to 3 groups: virtual reality intervention group (VR), relaxant video application group (RV) and control group (CG) by stratified randomization according to the disease stage and dryg type. During the chemotherapy treatment, the patients will take interactive/immersibe virtual reality (VR group) or relaxant video application (RV group) consisting of nature-themed scenarios. The interventions will be done 2 times and about 20 minutes in the first day of each chemotherapy cycles, in total 2 cycles. The control group will receive routine nursing care. Research data will be collected at different intervals during the chemotherapy course with the Patient Information Form (only once), the Edmonton Symptom Diagnosis Scale, the NCCN Distress Thermometer, the European Cancer Treatment and Organization Committee Quality of Life Scale and the Patient Follow-up Form and will be analyzed with the IBM SPSS v.23 program.

Detailed description: Lung cancer is one of the types of cancer with a high incidence and mortality rate in the world and in our country. Frequently used protocols in the chemotherapy treatment of lung cancer are the Platine-based drugs. The main side effects of this chemotherapy protocols are nausea, vomiting, neutropenia and fatigue. The side effects of cancer and chemotherapy cause patients to experience distress and their quality of life is adversely affected. In addition to pharmacological approaches, some non-pharmacological methods such as meditation, breathing exercises, and massage can be used to manage the symptoms experienced by patients due to chemotherapy. One of these methods is the virtual reality application, which has started to be used in the field of health with the developing technology, allowing individuals to experience another reality where they are. In addition, audio-visual (video) therapy methods are other methods that can be used in the symptom management of these patients. It is stated that virtual reality intervention and audio-visual therapies (relaxant video application) have positive effects on cancer patients and patients receiving chemotherapy treatment. In this study, the effect of interactive/immersive virtual reality intervention and relaxant video application on symptom severity, distress level and quality of life of patients diagnosed with lung cancer will be evaluated. Patients diagnosed with lung cancer, receiving chemotherapy treatment for the first time, and whose protocols are Cisplatine+Etoposide, Carboplatin+Etoposide, Paclitaxel+Carboplatine, Dosataxel+Cisplatine, Cisplatine+Pemetreksed, Carboplatine+Pemetreksed, Cisplatine+Vinorelbine, Gemsitebine+Cisplatine/Carboplatine and only Cisplatine, will be included in the study. Patients will be assigned to 3 groups: virtual reality application group (VR), relaxant video application group (RV) and control group (CG) by stratified randomization according to the disease stage and drug type. During the chemotherapy treatment, an interactive/immersive virtual reality intervention (VR group) and relaxant video intervention (RV group) consisting of nature-themed scenarios, which are preferred due to their relaxing effects, will be carried out for 2 times, about 20 minutes, the first day of each chemotherapy cycle, during 2 chemotherapy cycles. The control group will receive routine/standard nursing care. Research data will be collected at different intervals during the chemotherapy cures with the Patient Information Form (only once), the Edmonton Symptom Diagnosis Scale, the NCCN Distress Thermometer, the European Cancer Treatment and Organization Committee Quality of Life Scale and the Patient Follow-up Form and will be analyzed with the IBM SPSS v.23 program.

Eligibility criteria: Inclusion Criteria:

* are over 18 years old,
* diagnosed with lung cancer,
* will receive chemotherapy for the first time,
* will receive at least 2 cycles of chemotherapy treatment
* agree to participate in the study,

Exclusion Criteria:

* Having a cognitive and psychiatric disorder and diagnosis,
* Having brain metastasis or chronic disease related to the head-brain region,
* Having vision-hearing problems,
* Having epilepsy, vertigo, chronic severe headache, dizziness problems,
* Having a history of virtual reality, simulator or motion sickness,
* Having/declaring that he/she has open area, underwater, specific animal phobia,
* Do not agree to participate in the study

Primary outcomes:
measure: Edmonton Symptom Assessment Scale (ESAS)
timeFrame: First day of each chemotherapy cycle (totally 2 cycles) (2 times in about 21 days, totally 4 times in about 42 days or more)
Secondary outcomes:
measure: National Comprehensive Cancer Network Distress Thermometer (NCCN-DT)
timeFrame: (Before and after the interventios/for control groups same time -20 mins.-) First day of each chemotherapy cycle (totally 2 cycles) (2 times in about 21 days, totally 4 times in about 42 days or more)
measure: The European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-30)
timeFrame: First day of each chemotherapy cycle (totally 2 cycles) (2 times in about 21 days, totally 4 times in about 42 days or more)
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
state: Altındağ
Study officials:
References: