Status:
RECRUITING
Non-pharmacological Care for Depression in Cancer Patients Using VR and TMS
Lead Sponsor:
University Hospital of Ferrara
Collaborating Sponsors:
University Hospital of Cagliari
Conditions:
Depressive Symptoms
Quality of Life
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
Despite its significant impact on individuals and healthcare systems, substantial gaps remain in the clinical and rehabilitative management of depression in oncology patients. Depression in cancer pa...
Eligibility Criteria
Inclusion
- Diagnosis of oncological disease in the last 5 years
- Diagnosis of Major Depressive Disorder, without psychotic symptoms, according to DSM-5 criteria
- 17-item Hamilton Rating Scale for Depression (HAM-D-17) (score ≥14)
- Age: 18 years or older
- Oncological disease in a non-advanced stage (Karnofsky Performance Status \> 80)
Exclusion
- Current or prior hospitalization in the next 6 months
- Planned surgery in the next 6 months
- Suicidal ideation
- Substance use
- History of significant head trauma, neurological disorders, intellectual deficits
- Recurrent seizures resulting from head trauma or conditions lowering seizure threshold
- Concurrent use of medications that increase the risk of epileptic seizures (e.g., antipsychotics, tricyclics, theophylline)
- Glaucoma, retinal detachment, or other serious vision impairments that may prevent the use of virtual reality technology
- Severe problems with autonomous ambulation
Key Trial Info
Start Date :
August 21 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06589544
Start Date
August 21 2024
End Date
December 31 2027
Last Update
September 19 2024
Active Locations (2)
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1
Health Trust, Ferrara
Ferrara, FE, Italy, 44124
2
University Hospital of Cagliari
Cagliari, Italy, 09124