Status:
COMPLETED
Interest of Virtual Reality to Prevent Cancer Patient Anxiety Before Chemotherapy or an Invasive Act
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Anxiety
Chemotherapy Effect
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aim of the REV clinical trial is to evaluate the impact of a virtual reality exposure to decrease patient anxiety before chemotherapy or an invasive act. If positive, the access to virtual reality...
Detailed Description
The primary objective of the REV study is to demonstrate the difference of anxiety before and after a virtual reality exposure using the State-Trait Anxiety Inventory (STAI-Y) before patients undergo ...
Eligibility Criteria
Inclusion
- For all patients:
- Patient Study Information and written informed consent
- Social Security Affiliation
- For breast cancer cohort :
- Adult patient (\>18 years)
- Histological or cytological proven breast cancer
- Eligible to an adjuvant or neo-adjuvant IV chemotherapy given every 2 to 3 weeks (with protocol doxorubicin- cyclophosphamide, docetaxel-cyclophosmadide, docetaxel-cyclophosphamide-trastuzumab, docetaxel, carboplatine, trastuzumab, epirubicin-cyclophosphamide, etc)
- Therapeutic strategy validated in multidisciplinary meeting
- First chemotherapy cure (C1D1) not initiated yet
- Patients with a complete healing after resection (for adjuvant chemotherapy)
- Patients that do not report residual pain with an intensity \> 4.
- For head, neck and bladder cancer cohort :
- Adult patient (\>18 years)
- Histological or cytological proven head, neck or bladder cancer
- Patient eligible for an adjuvant or neoadjuvant based on cisplatin.
- Therapeutic strategy validated in multidisciplinary meeting
- First chemotherapy cure (C1D1) not initiated yet
- Patients with a complete healing after resection.
- Patients that do not report residual pain with an intensity \> 4.
- For invasive act leading to potential anxiety cohort :
- Adult patient (\>18 years)
- Histological or cytological proven cancer
- Patient with a planned hospitalization at oncological unit
- Eupneic patient
- Afebrile patient
- Patient for whom an invasive act leading to potential anxiety is planned (excluding percutaneous implantable chamber) :
- Puncture
- Deep biopsy
- Sounding
- Endoscopy without general anesthesia
- myelogram
Exclusion
- Patient with a consciousness disturbance or a spatio-temporal disturbance
- Claustrophobic patient
- Patient with a non-stabilized psychiatric pathology
- Patient with seizure crisis background
- Patient with a visual or hearing disturbance that is not compatible with video watching and sound listening
- Patients with out-of range clinical parameters (arterial pressure, cardiac frequency,..)
- Patients with out-of range blood parameters that are not compatible with chemotherapy or an invasive act.
- Patient with a life expectancy below 3 months.
- Impossibility to track and follow patient (any reason)
- Patient deprived of liberty or subjected to guardianship
Key Trial Info
Start Date :
June 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 16 2022
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT04419077
Start Date
June 7 2020
End Date
June 16 2022
Last Update
September 5 2023
Active Locations (1)
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1
Service d'oncologie médicale, Institut de Cancérologie des Hospices Civils de Lyon, Hôpital Lyon sud
Pierre-Bénite, France, 69495