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

May 9, 2022 updated by: Saint-Gregoire Private Hospital Center

Evaluation of Hypnosis in Virtual Reality on the Anxiety of Patients With Metastatic Prostate Cancer Over Chemotherapy Monocentric, Comparative, Randomized, Open Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

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 Locations

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

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: HypnoVR Arm
During each Docetaxel infusion, patients benefit from a 20-minute session of medical hypnosis in virtual reality.
Device: HYPNO VR® 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.
No Intervention: Control Arm
Patients receive the docetaxel infusions under standard conditions (no medical hypnosis in virtual reality intervention)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demonstrate a modification in anxiety after each infusion of Docetaxel in the HypnoVR arm compared to the control arm.
Time Frame: 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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Test the hypothesis that medical hypnosis in virtual reality is accompanied by a decrease in nausea before and after the Docetaxel cures
Time Frame: 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
Comparison of nausea (Analogical Visual Scale-VAS) before and after each infusion and at the end of treatment (i.e. 24 questionnaires) between the two arms. The analogical visual scale of nausea is a 6-point scale from "no nausea" to "maximum nausea". The higher the score is, the more important nausea are.
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
Time Frame: 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
Comparison of the number of vomiting episodes (n) before and after each infusion and at the end of treatment (i.e. 24 questionnaires) between the two arms.
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
Time Frame: For up to 6 months, one assessment questionnaire on day of inclusion and one assessment questionnaire at the end of study visit (month 6)
Comparison of the quality of life by the EQ-5D-3L questionnaire before the start of treatment with Docetaxel and after the end of treatment (after 12 infusions, ie two questionnaires) between the two arms. The EQ-5D-3L questionnaire has two components: health state description and evaluation. In the description part, health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The respondents self-rate their level of severity for each dimension using three-level (EQ-5D-3L).
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
Time Frame: For up to 6 months, one assessment questionnaire on day of inclusion and one assessment questionnaire at the end of study visit (month 6)
Comparison of the quality of life by the EQ-5D-3L questionnaire before the start of treatment with Docetaxel and after the end of treatment (after 12 infusions, ie two questionnaires) between the two arms. The EQ-5D-3L questionnaire has two components: health state description and evaluation. In the evaluation part, the respondents evaluate their overall health status using the visual analogic scale (EQ-VAS) from 0 (the worst state of health imaginable) to 100 (the best state of health imaginable).
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
Time Frame: For up to 6 months, one assessment questionnaire on day of inclusion and one assessment questionnaire at the end of study visit (month 6)
Comparison of the quality of life by the FACT-P questionnaire before the start of treatment with Docetaxel and after the end of treatment (after 12 infusions, ie two questionnaires) between the two arms. The FACT-P is a multidimensional, self-report quality of life instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. The respondents self-rate their level of severity for each item on a 5-points scale from 0 (not at all) to 4 (very much).
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 a good patient satisfaction after each infusion of Docetaxel
Time Frame: 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)
Evaluation of patient satisfaction in the HYPNO VR group by the patient self-questionnaire after each infusion of Docetaxel, i.e. 12 questionnaires. a level of satisfaction (on a 11-point scale from 0 to 10) of the patient will be measure for the state of relaxation, security, understanding, overall satisfaction.
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)
Test the hypothesis that medical hypnosis in virtual reality is accompanied by a modification in the prescription of antiemetic treatments
Time Frame: 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
Comparison of the proportion of antiemetic treatment prescriptions (dosage/posology stopped, added or changed) for each course between the two arms.
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

Collaborators and Investigators

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

Sponsor

Saint-Gregoire Private Hospital Center

Investigators

  • Principal Investigator: Xavier ARTIGNAN, MD, CHP Saint Grégoire

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)

September 28, 2020

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

August 11, 2020

First Submitted That Met QC Criteria

August 26, 2020

First Posted (Actual)

September 1, 2020

Study Record Updates

Last Update Posted (Actual)

May 10, 2022

Last Update Submitted That Met QC Criteria

May 9, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-A03336-51

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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