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Trial Title:
Use of a Virtual Reality Cognitive Stimulation Programme for Breast Cancer Patients Wishing to Restart or Maintain a Professional Activity
NCT ID:
NCT06267014
Condition:
Breast Cancer
Cancer-related Cognitive Difficulties
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
virtual reality
cognitive rehabilitation
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Patients will follow the Virtual Reality program developed for the study, during the
cognitive rehabilitation sessions
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Virtual Reality sessions
Description:
One session during 10-15 minutes per week for 6 weeks.
Arm group label:
Virtual Reality sessions
Summary:
The study concerns patients who have been treated for breast cancer, have cognitive
problems and are planning to return to work or are currently working and wish to begin
cognitive rehabilitation.
Patients will follow the Virtual Reality program developed for the study, during the
cognitive rehabilitation usually proposed in the establishment, at the rate of a weekly
session of 10-15 minute for 6 weeks.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients >18 years of age
- Patient with breast cancer for whom adjuvant chemotherapy has been administered;
maintenance treatments (e.g. Trastuzumab, hormone therapy) are eligible,
- Maximum 2 years after completion of adjuvant treatment,
- Patients who have cognitive complaints at inclusion (answer yes to the question:
'Since your cancer treatment, have you had any difficulties with memory,
concentration, etc.?)
- Patients planning to return to work or who have returned to work in the past year,
- Signature of informed consent prior to any specific procedure relating to the study,
- Patient affiliated to a social security system.
Exclusion Criteria:
- Patients suffering from illnesses or conditions that impair their ability to
understand, follow and/or comply with study procedures,
- Patients with personality disorders and/or psychiatric pathology,
- Patients deprived of their liberty or placed under the authority of a guardian,
- Pregnant women
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Centre François Baclesse
Address:
City:
Caen
Country:
France
Contact:
Last name:
Adeline MOREL, MD
Start date:
March 2024
Completion date:
June 2025
Lead sponsor:
Agency:
Centre Francois Baclesse
Agency class:
Other
Source:
Centre Francois Baclesse
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06267014
