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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| With virtual reality session | Experimental | Arm A patients will benefit from a 20-minute virtual reality session per chemotherapy session, for the first 3 cycles, with each session lasting more than 30 minutes. |
|
| Without virtual reality session | Other | Patients in arm B will receive conventional care without hypnotic support. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Measure the improvement in quality of life | Other | Improvment of quality of life is measured by the QLQ-C30 quality of life questionnaire |
|
| Measure | Description | Time Frame |
|---|---|---|
| QLQ-C30 | Measurement of the quality of life observed in patients. The QLQ-C30 questionnaire consists of 30 questions on the patient's state of physical and mental health. There are 28 questions with scores ranging from 1 = not at all to 4= very much and two questions with scores ranging from 1= very poor to 7= excellent. | 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 | Use of a patient questionnaire with a 10-point scale assessed on a five-point scale ranging from 1=strongly disagree disagree to 5 = strongly agree | after the first chemotherapy session on day 1 of cycle 1 and 3 (each cycle lasts 28 days) |
| MAT | Assessment of acute nausea and vomiting in patients induced by chemotherapy. 4 questions are used to assess nausea and vomiting 24 hours after chemotherapy and these 4 questions are again used to assess late nausea and vomiting. There are 2 questions with a yes or no choice, 1 question with a numerical answer and 1 question with a 10-point numerical scale with 0= none and 10= maximum difficulty. | after the first chemotherapy session on day 1 of cycle 2 and 3 (each cycle lasts 28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| VAS Score | Measures patients' anxiety and pain levels, as well as their fatigue levels. This questionnaire consists of 4 questions on pain levels, anxiety, fatigue and satisfaction with treatment. It is administered before and after chemotherapy. A 10-point numerical scale is used, with 0= the minimum and 10 =the maximum. | 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). |
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Inclusion Criteria:
exclusion criteria :
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Frédérique Mm Roussel | Contact | 0323067901 | f.roussel@ch-stquentin.fr | |
| Abdelkrim Mr Boulanouar | Contact | 0323067886 | ak.boulanouar@ch-stquentin.fr |
| Name | Affiliation | Role |
|---|---|---|
| Frédérique Mm Roussel | CH SAINT-QUENTIN | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier de Chauny | Recruiting | Chauny | 02300 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33538338 | Background | Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. | |
| 30125884 | Background | Colonna M, Boussari O, Cowppli-Bony A, Delafosse P, Romain G, Grosclaude P, Jooste V; French Network of Cancer Registries (FRANCIM). Time trends and short term projections of cancer prevalence in France. Cancer Epidemiol. 2018 Oct;56:97-105. doi: 10.1016/j.canep.2018.08.001. Epub 2018 Aug 17. |
| Label | URL |
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| The prevalence of long-term symptoms of depression and anxiety after breast cancer treatment: A systematic review | View source |
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the data will be collected on an electronic Ecrf, a single extraction is planned by the protocol, all the collected data will be analyzed centrally by the study cordernator,no data sharing is planned in the study
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non-randomized parallel two-arm comparative study with a group without virtual reality sessions and a group with virtual reality sessions
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| Measure the level of satisfaction of patients and nursing staff | Other | 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. |
|
| Measurement of anxiety and pain | Other | 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) |
|
| Measurement of depressive state | Other | Depressive State is measured by HAD score |
|
| measuring fatigue levels | Other | Fatigue levels is measured by Visual Analogue Scale (VAS). |
|
| measurement of acute nausea and vomiting | Other | acute nausea and vomiting is measured by MASCC Antiemesis Tool (MAT) |
|
| Heart rate | Measurement of heart rate in bpm. To assess the patient's level of anxiety and pain. Use of a multiparametric monitor. It will be collected before and after virtual reality. | 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 | Measurement of blood pressure in mmHg. To assess the patient's level of anxiety and pain. Use of a multiparametric monitor. It will be collected before and after virtual reality. | 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 | Assessment of the patient's state of depression and anxiety. There are 14 questions with scores ranging from 0 to 3 and different answer choices depending on the type of question. | 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). |
| Centre Hospitalier de Saint Quentin | Recruiting | Saint-Quentin | 02100 | France |
|
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| Projection de l'incidence et de la mortalité par cancer en France métropolitaine en 2017 | View source |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D011788 | Quality of Life |
| D009740 | Nursing Staff |
| ID | Term |
|---|---|
| D006304 | Health Status |
| D003710 | Demography |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D006282 | Health Personnel |
| D005159 | Health Care Facilities Workforce and Services |
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