Evaluation of Hypnosis in Virtual Reality on the Anxiety of Patients With Metastatic Prostate Cancer Over Chemotherapy

NCT04533958 | Recruiting

• 1 other identifier: 2019-A03336-51
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 6

Brief Summary

Prostate cancer is the first cancer in men. The treatment of metastatic prostate cancer with chemotherapy is based on the intravenous administration of docetaxel chemotherapy. Symptoms of anticipatory nausea, linked to anxiety caused by the treatment, may occur. Hypnosis is already used to treat the anxiety of people with cancer and can help treat the symtoms of nausea and vomiting of women with breast cancer. The purpose of the study is to evaluate the effect of medical hypnosis in virtual reality on the anxiety of patients with metastatic prostate cancer receiving Docetaxel chemotherapy treatment in comparison with a control group.

Conditions

Metastatic Prostate Cancer

Keywords

Virtual reality; Oncology; Chemotherapy; Anxiety

Outcome Measures

Primary Outcomes (1)

• Demonstrate a modification in anxiety after each infusion of Docetaxel in the HypnoVR arm compared to the control arm.

  Comparison of anxiety by the State Trait Anxiety Inventory (STAI) score before and after each docetaxel infusion (i.e. 24 questionnaires) between the HypnoVR arm and the control arm. The score is a quantitative variable with values ranging from 20 to 80. The higher the score is, the more important the anxiety is.

  For up to 6 months, every 2 weeks (before and after the 12 infusions), starting on day of first infusion until day of the last twelfth infusion

Secondary Outcomes (7)

• Test the hypothesis that medical hypnosis in virtual reality is accompanied by a decrease in nausea before and after the Docetaxel cures

  For up to 6 months, every 2 weeks (before and after the 12 infusions), starting on day of first infusion until day of the last twelfth infusion

• Test the hypothesis that medical hypnosis in virtual reality is accompanied by a decrease in vomiting before and after the Docetaxel cures

  For up to 6 months, every 2 weeks (before and after the 12 infusions), starting on day of first infusion until day of the last twelfth infusion

• Test the hypothesis that medical hypnosis in virtual reality is accompanied by an increase in the quality of life by the EQ-5D-3L questionnaire for the health state description part after the end of treatment

  For up to 6 months, one assessment questionnaire on day of inclusion and one assessment questionnaire at the end of study visit (month 6)

• Test the hypothesis that medical hypnosis in virtual reality is accompanied by an increase in the quality of life by the EQ-5D-3L questionnaire for the health state evaluation part after the end of treatment

  For up to 6 months, one assessment questionnaire on day of inclusion and one assessment questionnaire at the end of study visit (month 6)

• Test the hypothesis that medical hypnosis in virtual reality is accompanied by an increase in the quality of life by the FACT-P (Functional Assessment of Cancer Therapy-Prostate) questionnaire after the end of treatment

  For up to 6 months, one assessment questionnaire on day of inclusion and one assessment questionnaire at the end of study visit (month 6)

Study Arms (2)

HypnoVR Arm

EXPERIMENTAL

During each Docetaxel infusion, patients benefit from a 20-minute session of medical hypnosis in virtual reality.

Device: HYPNO VR® device

Control Arm

NO INTERVENTION

Patients receive the docetaxel infusions under standard conditions (no medical hypnosis in virtual reality intervention)

Interventions

HYPNO VR® device DEVICE

The HYPNO VR® device is a software application of medical hypnosis in the treatment of pain and anxiety. It is associated with equipment: a virtual reality headset and a headphone. Before each Docetaxel infusion, the nursing staff offers patients the choices: visual universe, musical theme, male or female voice. The nursing staff selects the chemotherapy program, selects a duration of 20 minutes and presses start to start the medical hypnosis session in virtual reality. After completing the hypnotic trance sequence, as in a classic session, the patient is brought back to the "return" and exit hypnosis phase under the supervision of the nursing staff.

HypnoVR Arm

Eligibility Criteria

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

You may qualify if:

• Man aged ≥ 18 years
• Histologically proven metastatic prostate adenocarcinoma,
• Patient undergoing chemotherapy according to the following conventional scheme: 12 courses of Docetaxel every two weeks
• Patient who signed their informed consent
• Patient benefiting from social security coverage
• Patient treated and followed in the center for the duration of the study (6 months maximum).

You may not qualify if:

• Patient participating in another clinical trial on an experimental molecule
• Patient who received previous chemotherapy
• Patient unable to submit to protocol monitoring for psychological, social, family or geographic reasons
• Patient deprived of their liberty or under guardianship

Sponsors & Collaborators

• Saint-Gregoire Private Hospital Center: lead

Study Sites (6)

Clinique Pasteur-Lanroze

Brest, 29200, France

RECRUITING

CHP Saint-Grégoire

Saint-Grégoire, 35760, France

RECRUITING

Clinique de la Côte d'Emeraude

St-Malo, 35400, France

RECRUITING

Hospital Lusiadas Amadora

Amadora, 2724-002, Portugal

RECRUITING

Hospital Lusiadas Lisboa

Lisbon, 1500-458, Portugal

RECRUITING

Hospital Lusiadas Porto

Porto, 4050-115, Portugal

NOT YET RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms; Anxiety Disorders

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Mental Disorders

Study Officials

• Xavier ARTIGNAN, MD

  CHP Saint Grégoire

  PRINCIPAL INVESTIGATOR

Central Study Contacts

BELLEC-FAGOT

CONTACT

0637110376; mbellecfagot@vivalto-sante.com

Study Design

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

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: September 1, 2020
• Study Start: September 28, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3); PT (3)