Back to resultsEvaluation of Hypnosis in Virtual Reality on the Anxiety of Patients With Metastatic Prostate Cancer Over Chemotherapy (HypProMet)
Primary Purpose
Metastatic Prostate Cancer
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
HYPNO VR® device
Sponsored by
About this trial
This is an interventional supportive care trial for Metastatic Prostate Cancer focused on measuring Virtual reality, Oncology, Chemotherapy, Anxiety
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
Sites / Locations
- CHP Saint-GrégoireRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
HypnoVR Arm
Control Arm
Arm Description
During each Docetaxel infusion, patients benefit from a 20-minute session of medical hypnosis in virtual reality.
Patients receive the docetaxel infusions under standard conditions (no medical hypnosis in virtual reality intervention)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Test the hypothesis that medical hypnosis in virtual reality is accompanied by a decrease in nausea before and after the Docetaxel cures
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.
Test the hypothesis that medical hypnosis in virtual reality is accompanied by a decrease in vomiting before and after the Docetaxel cures
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.
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
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).
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
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).
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
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).
Test the hypothesis that medical hypnosis in virtual reality is accompanied by a good patient satisfaction after each infusion of Docetaxel
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.
Test the hypothesis that medical hypnosis in virtual reality is accompanied by a modification in the prescription of antiemetic treatments
Comparison of the proportion of antiemetic treatment prescriptions (dosage/posology stopped, added or changed) for each course between the two arms.
Full Information
NCT ID
NCT04533958
First Posted
August 11, 2020
Last Updated
May 9, 2022
Sponsor
Saint-Gregoire Private Hospital Center
1. Study Identification
Unique Protocol Identification Number
NCT04533958
Brief Title
Evaluation of Hypnosis in Virtual Reality on the Anxiety of Patients With Metastatic Prostate Cancer Over Chemotherapy
Acronym
HypProMet
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
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 28, 2020 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Saint-Gregoire Private Hospital Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Prostate Cancer
Keywords
Virtual reality, Oncology, Chemotherapy, Anxiety
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HypnoVR Arm
Arm Type
Experimental
Arm Description
During each Docetaxel infusion, patients benefit from a 20-minute session of medical hypnosis in virtual reality.
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
Patients receive the docetaxel infusions under standard conditions (no medical hypnosis in virtual reality intervention)
Intervention Type
Device
Intervention Name(s)
HYPNO VR® device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Demonstrate a modification in anxiety after each infusion of Docetaxel in the HypnoVR arm compared to the control arm.
Description
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.
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
Secondary Outcome Measure Information:
Title
Test the hypothesis that medical hypnosis in virtual reality is accompanied by a decrease in nausea before and after the Docetaxel cures
Description
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.
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
Title
Test the hypothesis that medical hypnosis in virtual reality is accompanied by a decrease in vomiting before and after the Docetaxel cures
Description
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.
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
Title
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
Description
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).
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)
Title
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
Description
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).
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)
Title
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
Description
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).
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)
Title
Test the hypothesis that medical hypnosis in virtual reality is accompanied by a good patient satisfaction after each infusion of Docetaxel
Description
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.
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)
Title
Test the hypothesis that medical hypnosis in virtual reality is accompanied by a modification in the prescription of antiemetic treatments
Description
Comparison of the proportion of antiemetic treatment prescriptions (dosage/posology stopped, added or changed) for each course between the two arms.
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BELLEC-FAGOT
Phone
0637110376
Email
mbellecfagot@vivalto-sante.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xavier ARTIGNAN, MD
Organizational Affiliation
CHP Saint Grégoire
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHP Saint-Grégoire
City
Saint-Grégoire
ZIP/Postal Code
35760
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
BELLEC-FAGOT
Phone
06.37.11.03.76
Email
mbellecfagot@vivalto-sante.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of Hypnosis in Virtual Reality on the Anxiety of Patients With Metastatic Prostate Cancer Over Chemotherapy
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