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

NCT06485869 | Recruiting

• 1 other identifier: 2023-A01543-42
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

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

Conditions

Cancer

Outcome Measures

Primary Outcomes (3)

• 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)

Secondary Outcomes (4)

• VAS Score

  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

  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

  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

  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).

Study Arms (2)

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.

Other: Measure the improvement in quality of life; Other: Measure the level of satisfaction of patients and nursing staff; Other: Measurement of anxiety and pain; Other: Measurement of depressive state; Other: measuring fatigue levels; Other: measurement of acute nausea and vomiting

Without virtual reality session

OTHER

Patients in arm B will receive conventional care without hypnotic support.

Other: Measure the improvement in quality of life; Other: Measure the level of satisfaction of patients and nursing staff; Other: Measurement of anxiety and pain; Other: Measurement of depressive state; Other: measuring fatigue levels; Other: measurement of acute nausea and vomiting

Interventions

Measure the improvement in quality of life OTHER

Improvment of quality of life is measured by the QLQ-C30 quality of life questionnaire

With virtual reality session; Without virtual reality session

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.

With virtual reality session; Without virtual reality session

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)

With virtual reality session; Without virtual reality session

Measurement of depressive state OTHER

Depressive State is measured by HAD score

With virtual reality session; Without virtual reality session

measuring fatigue levels OTHER

Fatigue levels is measured by Visual Analogue Scale (VAS).

With virtual reality session; Without virtual reality session

measurement of acute nausea and vomiting OTHER

acute nausea and vomiting is measured by MASCC Antiemesis Tool (MAT)

With virtual reality session; Without virtual reality session

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central Hospital Saint Quentin: lead

Study Sites (2)

Centre Hospitalier de Chauny

Chauny, 02300, France

RECRUITING

Centre Hospitalier de Saint Quentin

Saint-Quentin, 02100, France

RECRUITING

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Related Links

• The prevalence of long-term symptoms of depression and anxiety after breast cancer treatment: A systematic review
• Projection de l'incidence et de la mortalité par cancer en France métropolitaine en 2017

MeSH Terms

Conditions

Neoplasms

Interventions

Quality of Life; Nursing Staff

Intervention Hierarchy (Ancestors)

Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health; Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• Frédérique Mm Roussel

  CH SAINT-QUENTIN

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frédérique Mm Roussel

CONTACT

0323067901; f.roussel@ch-stquentin.fr

Abdelkrim Mr Boulanouar

CONTACT

0323067886; ak.boulanouar@ch-stquentin.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: non-randomized parallel two-arm comparative study with a group without virtual reality sessions and a group with virtual reality sessions

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: July 3, 2024
• Study Start: November 1, 2023
• Primary Completion (Estimated): August 29, 2026
• Study Completion (Estimated): August 29, 2026
• Last Updated: July 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)