Impact of Virtual Reality on the Quality of Life of Oncology Patients

Обзор

Anxiety, nausea and vomiting are common side effects in paediatric patients receiving chemotherapy. chemotherapy. New evidence supports the efficacy of immersive virtual reality in improving symptoms of anxiety and distress, including nausea and vomiting, in this vulnerable group. This research will evaluate the efficacy of virtual reality in managing anxiety, nausea and vomiting in cancer patients receiving their first line of chemotherapy and will also measure the quality of life of these patients and evaluate patient and nursing staff satisfaction

Подробное описание

For cancer patients, virtual reality proved more effective than other forms of distraction in relieving anxiety, depression and fatigue during chemotherapy. Although pain and anxiety in cancer patients are managed proactively, this study was designed to measure the quality of life of these patients, assess patient and carer satisfaction, evaluate the effectiveness of virtual reality in reducing anxiety during the first three sessions of chemotherapy, and assess the impact of virtual reality on preventive and acute chemotherapy-induced fatigue, nausea and vomiting.

This is a clinical study with a therapeutic aim using a non-medicinal, interventional, prospective, multi-centre, controlled and randomised technique, with two parallel groups. It is clinical research involving the human person category 2, involving only minimal risks and constraints. The two arms are Arm A: study questionnaires with virtual reality (VR) Arm B: study questionnaires without virtual reality, standard care (SC)

A visit will be made during the 3 cycles of chemotherapy during which arm A will be immersed in Virtual Reality with the Healthy Mind VR programme.

programme, and patients in arm B will receive standard care without hypnotic support.

There will also be a pre-inclusion visit 7 days before the first cycle. and visits at 3, 6 and 9 months after the 3 cycles of chemotherapy.

Вмешательства

• Другое Measure the improvement in quality of life
  Improvment of quality of life is measured by the QLQ-C30 quality of life questionnaire
• Другое Measure the level of satisfaction of patients and nursing staff
  Patient satisfaction is measured using a five-point scale ranging from 1 = strongly disagree to 5 = strongly agree. Higher scores indicate higher levels of satisfaction.
• Другое Measurement of anxiety and pain
  Anxiety and pain is measured by Visual Analogue Scale (VAS). This measurement is complemented by physiological responses to anxiety, measured by heart rate and mean arterial blood pressure (HR and BP)
• Другое Measurement of depressive state
  Depressive State is measured by HAD score
• Другое measuring fatigue levels
  Fatigue levels is measured by Visual Analogue Scale (VAS).
• Другое measurement of acute nausea and vomiting
  acute nausea and vomiting is measured by MASCC Antiemesis Tool (MAT)

Первичные конечные точки

• QLQ-C30 [Срок оценки: at the start of cycle 1 (each cycle is 28 days); 3,6,9 months post chemo, at the beginning of the 3rd month post chemo, at the beginning of the 6th month post chemo and at the beginning of the 9th month post chemo]
• Measuring patient and nurse satisfaction with the chemotherapy procedure [Срок оценки: after the first chemotherapy session on day 1 of cycle 1 and 3 (each cycle lasts 28 days)]
• MAT [Срок оценки: after the first chemotherapy session on day 1 of cycle 2 and 3 (each cycle lasts 28 days)]

Вторичные конечные точки (4)

• VAS Score [Срок оценки: Before the start of the first chemotherapy session on day 1 of cycle 1, 2 and 3 (each cycle is 28 days) and after the end of the first chemotherapy session on day 1 of cycle 1, 2 and 3 (each cycle is 28 days).]
• Heart rate [Срок оценки: Before the start of the first chemotherapy session on day 1 of cycle 1, 2 and 3 (each cycle is 28 days) and after the end of the first chemotherapy session on day 1 of cycle 1, 2 and 3 (each cycle is 28 days).]
• Blood pressure [Срок оценки: Before the start of the first chemotherapy session on day 1 of cycle 1, 2 and 3 (each cycle is 28 days) and after the end of the first chemotherapy session on day 1 of cycle 1, 2 and 3 (each cycle is 28 days).]
• HAD Score [Срок оценки: Before the start of the first chemotherapy session on day 1 of cycle 1 (each cycle is 28 days) and after the end of the first chemotherapy session on day 1 of cycle 1 and 2 (each cycle is 28 days).]

Критерии участия

Критерии включения

• Chemotherapy-naive patient
• Patient with first-line indication for intravenous cyclic chemotherapy
• Affiliated to a social security system
• Having received full information on the organization of the research and having given free, informed and written consent signed by the participant and the investigator
• Patient understands French or English
• Expected duration of chemotherapy session for the first 3 cycles greater than 30 minutes

Критерии исключения

• Patient with communication disorders preventing informed consent
• Patient under legal protection (guardianship, curatorship, safeguard of justice)
• Patients suffering from epilepsy
• Severe visual or hearing impairment preventing use of headphones
• Psychiatric pathologies such as delusional disorders, hallucinations or schizophrenia.
• Patients with infections or facial wounds
• Patients with severe claustrophobia
• Patients with pacemakers
• Patients with known cognitive or learning problems,
• Patients with brain tumors or metastases,
• Patients suffering from motion sickness
• Expected duration of chemotherapy session for the first 3 cycles of 30 minutes or less.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Франция · 2 центра

• Centre Hospitalier de Chauny — Chauny
• Centre Hospitalier de Saint Quentin — Saint-Quentin

Публикации

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• Molassiotis A, Lee PH, Burke TA, Dicato M, Gascon P, Roila F, Aapro M. Anticipatory Nausea, Risk Factors, and Its Impact on Chemotherapy-Induced Nausea and Vomiting: Results From the Pan European Emesis Registry Study. J Pain Symptom Manage. 2016 Jun;51(6):987-93. doi: 10.1016/j.jpainsymman.2015.12.317. Epub 2016 Feb 16. PMID 26891606
• Morrow GR, Roscoe JA, Kirshner JJ, Hynes HE, Rosenbluth RJ. Anticipatory nausea and vomiting in the era of 5-HT3 antiemetics. Support Care Cancer. 1998 May;6(3):244-7. doi: 10.1007/s005200050161. PMID 9629877
• Dupuis LL, Sung L, Molassiotis A, Orsey AD, Tissing W, van de Wetering M. 2016 updated MASCC/ESMO consensus recommendations: Prevention of acute chemotherapy-induced nausea and vomiting in children. Support Care Cancer. 2017 Jan;25(1):323-331. doi: 10.1007/s00520-016-3384-y. Epub 2016 Aug 26. PMID 27565788

Идентификаторы

NCT: NCT06485869 · 2023-A01543-42

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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