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CancerVIRONSCARENCT06485869

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

A study testing Measure the improvement in quality of life, Measure the level of satisfaction of patients and nursing staff and Measurement of anxiety and pain in people with Cancer, run by Central Hospital Saint Quentin at 2 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer
What is being tested?
Measure the improvement in quality of life, Measure the level of satisfaction of patients and nursing staff and Measurement of anxiety and pain
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
2 sitesFrance
Study dates
1 Nov 2023to 29 Aug 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country.

Frédérique Mm Roussel contact

0323067901

f.roussel@ch-stquentin.fr

Abdelkrim Mr Boulanouar contact

0323067886

ak.boulanouar@ch-stquentin.fr

France2 sites, 2 recruiting

  • Centre Hospitalier de Chauny

    Chauny, 02300

    Jerome Dr Cherry, 06 08 22 95 99, jerome.chery@ch-chauny.fr

    Recruiting

  • Centre Hospitalier de Saint Quentin

    Saint-Quentin, 02100

    Frédérique DR Roussel

    Recruiting

Other trials in France

About this study

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

Read the 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.

Conditions
Cancer
Being tested
Measure the improvement in quality of life, Measure the level of satisfaction of patients and nursing staff, Measurement of anxiety and pain, Measurement of depressive state, measuring fatigue levels
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Measure the improvement in quality of lifeOther

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

  • Measure the level of satisfaction of patients and nursing staffOther

    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 painOther

    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 stateOther

    Depressive State is measured by HAD score

  • measuring fatigue levelsOther

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

  • measurement of acute nausea and vomitingOther

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

Study groups in NCT06485869
Study groupRoleWhat they receive
With virtual reality sessionExperimentalArm 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.
Receives: 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 sessionOtherPatients in arm B will receive conventional care without hypnotic support.
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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

  2. 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

    Measured: after the first chemotherapy session on day 1 of cycle 1 and 3 (each cycle lasts 28 days)

  3. 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.

    Measured: after the first chemotherapy session on day 1 of cycle 2 and 3 (each cycle lasts 28 days)

Secondary outcomes (4)

  1. 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.

    Measured: 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).

  2. 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.

    Measured: 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).

  3. 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.

    Measured: 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).

  4. 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.

    Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2024
  2. Study start1 Nov 2023
  3. Primary completion29 Aug 2026 (estimated)
  4. Study completion29 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
non-randomized parallel two-arm comparative study with a group without virtual reality sessions and a group with virtual reality sessions
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06485869
Sponsor's protocol ID
2023-A01543-42
Acronym
VIRONSCARE
Status last verified
May 2024
First submitted
3 May 2024
Last updated
3 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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

Publications

  • 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.

    PubMed 33538338

  • 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.

    PubMed 30125884

  • Carnio S, Galetta D, Scotti V, Cortinovis DL, Antonuzzo A, Pisconti S, Rossi A, Martelli O, Cecere FL, Lunghi A, Del Conte A, Montagna ES, Topulli J, Pelizzoni D, Rapetti SG, Gianetta M, Pacchiana MV, Pegoraro V, Cataldo N, Bria E, Novello S. Chemotherapy-induced nausea and vomiting (CINV) in patients with advanced lung cancer during the first-line treatment: assessment by physicians, nurses, and patients from an Italian multicenter survey. Support Care Cancer. 2018 Jun;26(6):1841-1849. doi: 10.1007/s00520-017-4004-1. Epub 2017 Dec 21.

    PubMed 29270827

  • Schneider SM, Workman ML. Effects of virtual reality on symptom distress in children receiving chemotherapy. Cyberpsychol Behav. 1999;2(2):125-34. doi: 10.1089/cpb.1999.2.125.

    PubMed 19178248

  • Chan A, Kim HK, Hsieh RK, Yu S, de Lima Lopes G Jr, Su WC, Banos A, Bhatia S, Burke TA, Keefe DM. Incidence and predictors of anticipatory nausea and vomiting in Asia Pacific clinical practice--a longitudinal analysis. Support Care Cancer. 2015 Jan;23(1):283-91. doi: 10.1007/s00520-014-2375-0. Epub 2014 Aug 13.

    PubMed 25112561

  • 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.

    PubMed 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.

    PubMed 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.

    PubMed 27565788

  • Huertas-Fernandez MJ, Martinez-Bautista MJ, Sanchez-Martinez I, Zarzuela-Ramirez M, Baena-Canada JM. [Analysis of the effectiveness of an antiemetic protocol used in an oncology division]. Farm Hosp. 2010 May-Jun;34(3):125-38. doi: 10.1016/j.farma.2009.11.001. Spanish.

    PubMed 20206564

  • Hesketh PJ. Chemotherapy-induced nausea and vomiting. N Engl J Med. 2008 Jun 5;358(23):2482-94. doi: 10.1056/NEJMra0706547. No abstract available.

    PubMed 18525044

  • Birnie KA, Noel M, Parker JA, Chambers CT, Uman LS, Kisely SR, McGrath PJ. Systematic review and meta-analysis of distraction and hypnosis for needle-related pain and distress in children and adolescents. J Pediatr Psychol. 2014 Sep;39(8):783-808. doi: 10.1093/jpepsy/jsu029. Epub 2014 Jun 2.

    PubMed 24891439

  • Vol H, Flank J, Lavoratore SR, Nathan PC, Taylor T, Zelunka E, Maloney AM, Lee Dupuis L. Poor chemotherapy-induced nausea and vomiting control in children receiving intermediate or high dose methotrexate. Support Care Cancer. 2016 Mar;24(3):1365-71. doi: 10.1007/s00520-015-2924-1. Epub 2015 Sep 3.

    PubMed 26335406

  • Ovayolu N, Ovayolu O, Serce S, Tuna D, Pirbudak Cocelli L, Sevinc A. Pain and quality of life in Turkish cancer patients. Nurs Health Sci. 2013 Dec;15(4):437-43. doi: 10.1111/nhs.12047. Epub 2013 Mar 11.

    PubMed 23480371

  • Ahmed RL, Prizment A, Lazovich D, Schmitz KH, Folsom AR. Lymphedema and quality of life in breast cancer survivors: the Iowa Women's Health Study. J Clin Oncol. 2008 Dec 10;26(35):5689-96. doi: 10.1200/JCO.2008.16.4731. Epub 2008 Nov 10.

    PubMed 19001331

  • Dupuis LL, Robinson PD, Boodhan S, Holdsworth M, Portwine C, Gibson P, Phillips R, Maan C, Stefin N, Sung L; Pediatric Oncology Group of Ontario. Guideline for the prevention and treatment of anticipatory nausea and vomiting due to chemotherapy in pediatric cancer patients. Pediatr Blood Cancer. 2014 Aug;61(8):1506-12. doi: 10.1002/pbc.25063. Epub 2014 Apr 17.

    PubMed 24753095

Questions about this trial

What is this clinical trial studying?

A study testing Measure the improvement in quality of life, Measure the level of satisfaction of patients and nursing staff and Measurement of anxiety and pain in people with Cancer, run by Central Hospital Saint Quentin at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Frédérique Mm Roussel (0323067901, f.roussel@ch-stquentin.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06485869, which also lists 26 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.

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