Using virtual reality hypnosis to reduce anxiety in men with metastatic prostate cancer undergoing chemotherapy
Evaluation of Hypnosis in Virtual Reality on the Anxiety of Patients With Metastatic Prostate Cancer Over Chemotherapy Monocentric, Comparative, Randomized, Open Study
This study is testing whether virtual reality hypnosis can help reduce anxiety in men with metastatic prostate cancer who are undergoing chemotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Saint-Gregoire Private Hospital Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 6 sites (Brest and 5 other locations) |
| Trial ID | NCT04533958 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a virtual reality hypnosis intervention on reducing anxiety in patients with metastatic prostate cancer who are receiving docetaxel chemotherapy. Participants will be randomly assigned to either the hypnosis group or a control group, with the study lasting for the duration of 12 chemotherapy courses. The aim is to determine if this innovative approach can alleviate anxiety and improve the overall treatment experience for these patients.
Who should consider this trial
Good fit: Ideal candidates are men aged 18 and older with histologically confirmed metastatic prostate adenocarcinoma who are starting chemotherapy with docetaxel.
Not a fit: Patients who have previously undergone chemotherapy or are participating in another clinical trial may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce anxiety levels in patients undergoing chemotherapy for metastatic prostate cancer.
How similar studies have performed: Previous studies have shown that hypnosis can effectively reduce anxiety in cancer patients, suggesting potential success for this novel application in prostate cancer.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Brest and 5 other locations
- Clinique Pasteur-Lanroze — Brest, France (Recruiting)
- CHP Saint-Grégoire — Saint-Grégoire, France (Recruiting)
- Clinique de la Côte d'Emeraude — Saint-Malo, France (Recruiting)
- Hospital Lusiadas Amadora — Amadora, Portugal (Recruiting)
- Hospital Lusiadas Lisboa — Lisboa, Portugal (Recruiting)
- Hospital Lusiadas Porto — Porto, Portugal (Not_yet_recruiting)
Study contacts
- Principal investigator: Xavier ARTIGNAN, MD — CHP Saint Grégoire
- Study coordinator: Bellec-Fagot
- Email: mbellecfagot@vivalto-sante.com
- Phone: 0637110376
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.