Clinical trial NCT06485869: Impact of Virtual Reality on the Quality of Life of Oncology Patients
Official title: Impact of Virtual Reality on the Quality of Life of Oncology Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Lead sponsor: Central Hospital Saint Quentin
Sponsor class: OTHER_GOV
First posted: 2024-07-03
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: non-randomized parallel two-arm comparative study with a group without virtual reality sessions and a group with virtual reality sessions
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

exclusion criteria :

* 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.

Primary outcomes:
measure: QLQ-C30
timeFrame: 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
measure: Measuring patient and nurse satisfaction with the chemotherapy procedure
timeFrame: after the first chemotherapy session on day 1 of cycle 1 and 3 (each cycle lasts 28 days)
measure: MAT
timeFrame: after the first chemotherapy session on day 1 of cycle 2 and 3 (each cycle lasts 28 days)
Secondary outcomes:
measure: VAS Score
timeFrame: 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).
measure: Heart rate
timeFrame: 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).
measure: Blood pressure
timeFrame: 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).
measure: HAD Score
timeFrame: 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).
Other outcomes:
Locations:
city: Chauny
country: France
facility: Centre Hospitalier de Chauny
city: Saint-Quentin
country: France
facility: Centre Hospitalier de Saint Quentin
Study officials:
affiliation: CH SAINT-QUENTIN
name: Frédérique Mm Roussel
role: PRINCIPAL_INVESTIGATOR
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