Impact of Virtual Reality on the Quality of Life of Oncology Patients (VIRONSCARE)

June 26, 2024 updated by: Central Hospital Saint Quentin
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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Chauny, France, 02300
        • Recruiting
        • Centre Hospitalier de Chauny
        • Contact:
      • Saint-Quentin, France, 02100
        • Recruiting
        • Centre Hospitalier de Saint Quentin
        • Contact:
          • Frédérique DR Roussel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: With virtual reality session
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.
Other: Measure the improvement in quality of life
Improvment of quality of life is measured by the QLQ-C30 quality of life questionnaire
Other: 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.
Other: 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)
Other: Measurement of depressive state
Depressive State is measured by HAD score
Other: measuring fatigue levels
Fatigue levels is measured by Visual Analogue Scale (VAS).
Other: measurement of acute nausea and vomiting
acute nausea and vomiting is measured by MASCC Antiemesis Tool (MAT)
Other: Without virtual reality session
Patients in arm B will receive conventional care without hypnotic support.
Other: Measure the improvement in quality of life
Improvment of quality of life is measured by the QLQ-C30 quality of life questionnaire
Other: 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.
Other: 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)
Other: Measurement of depressive state
Depressive State is measured by HAD score
Other: measuring fatigue levels
Fatigue levels is measured by Visual Analogue Scale (VAS).
Other: measurement of acute nausea and vomiting
acute nausea and vomiting is measured by MASCC Antiemesis Tool (MAT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
QLQ-C30
Time Frame: 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
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
Time Frame: after the first chemotherapy session on day 1 of cycle 1 and 3 (each cycle lasts 28 days)
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
Time Frame: after the first chemotherapy session on day 1 of cycle 2 and 3 (each cycle lasts 28 days)

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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS Score
Time Frame: 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).

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).
Heart rate
Time Frame: 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).
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
Time Frame: 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).
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
Time Frame: 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).
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital Saint Quentin

Investigators

  • Principal Investigator: Frédérique Mm Roussel, CH Saint-Quentin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Estimated)

August 29, 2026

Study Completion (Estimated)

August 29, 2026

Study Registration Dates

First Submitted

May 3, 2024

First Submitted That Met QC Criteria

June 26, 2024

First Posted (Actual)

July 3, 2024

Study Record Updates

Last Update Posted (Actual)

July 3, 2024

Last Update Submitted That Met QC Criteria

June 26, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 2023-A01543-42

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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