Clinical trial NCT04533958: Evaluation of Hypnosis in Virtual Reality on the Anxiety of Patients With Metastatic Prostate Cancer Over Chemotherapy
Official title: Evaluation of Hypnosis in Virtual Reality on the Anxiety of Patients With Metastatic Prostate Cancer Over Chemotherapy Monocentric, Comparative, Randomized, Open Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Metastatic Prostate Cancer
Keywords: Virtual reality
Oncology
Chemotherapy
Anxiety
Lead sponsor: Saint-Gregoire Private Hospital Center
Sponsor class: OTHER
First posted: 2020-09-01
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: After verifying the patient's eligibility criteria and obtaining the signed informed consent form, the patient is randomized to the arm receiving hypnosis in virtual reality or to the control arm. The study ends after the 12 courses of docetaxel or premature termination of the study.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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
* Patient with underlying or concomitant pathology incompatible with inclusion in the trial, whether psychiatric or somatic

Primary outcomes:
measure: Demonstrate a modification in anxiety after each infusion of Docetaxel in the HypnoVR arm compared to the control arm.
timeFrame: 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:
measure: Test the hypothesis that medical hypnosis in virtual reality is accompanied by a decrease in nausea before and after the Docetaxel cures
timeFrame: 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
measure: Test the hypothesis that medical hypnosis in virtual reality is accompanied by a decrease in vomiting before and after the Docetaxel cures
timeFrame: 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
measure: 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
timeFrame: For up to 6 months, one assessment questionnaire on day of inclusion and one assessment questionnaire at the end of study visit (month 6)
measure: 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
timeFrame: For up to 6 months, one assessment questionnaire on day of inclusion and one assessment questionnaire at the end of study visit (month 6)
measure: 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
timeFrame: For up to 6 months, one assessment questionnaire on day of inclusion and one assessment questionnaire at the end of study visit (month 6)
measure: Test the hypothesis that medical hypnosis in virtual reality is accompanied by a good patient satisfaction after each infusion of Docetaxel
timeFrame: For up to 6 months, every 2 weeks (after each infusion), starting on day of first infusion until day of the last twelfth infusion (month 6)
measure: Test the hypothesis that medical hypnosis in virtual reality is accompanied by a modification in the prescription of antiemetic treatments
timeFrame: For up to 6 months, every 2 weeks (before each infusion), starting on day of the first infusion until the day of the last twelfth infusion
Other outcomes:
Locations:
city: Brest
country: France
facility: Clinique Pasteur-Lanroze
city: Saint-Grégoire
country: France
facility: CHP Saint-Grégoire
city: Saint-Malo
country: France
facility: Clinique de la Côte d'Emeraude
city: Amadora
country: Portugal
facility: Hospital Lusiadas Amadora
city: Lisboa
country: Portugal
facility: Hospital Lusiadas Lisboa
city: Porto
country: Portugal
facility: Hospital Lusiadas Porto
Study officials:
affiliation: CHP Saint Grégoire
name: Xavier ARTIGNAN, MD
role: PRINCIPAL_INVESTIGATOR
References: