SIMPLIF-AI: SIMPLIFication and Standardization of Care Pathways for Patients With Rare Brain Tumors Through Artificial Intelligence
Trial ID: NCT06878469
Status: RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2025-01-27
Completion date: 2027-02
Sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Collaborators: ASL 1 Avezzano Sulmona L'Aquila
Conditions: Brain Tumors
Interventions: RehaCom
Locations: Fondazione IRCCS Istituto Neurologico Carlo Besta; ASL 1 Abruzzo Avezzano-Sulmona-L'Aquila
Countries: Italy; Italy
Enrollment: 200
Age range: 18 Years - None
Sex: ALL

Summary:
This study focuses on rare brain tumors, which are heterogeneous entities with different morphological, biological, and clinical characteristics. Due to their rarity, many of these tumors fall under the RARECARE definition of rare tumors. The main objective of the study is to standardize care models and pathways for patients with rare brain tumors, using Artificial Intelligence (AI) and Machine Learning (ML) techniques to identify specific predictors of postoperative outcomes.

The study includes both retrospective and prospective phases, with the collection of clinical, cognitive, and psychological data at various time points. Patients will undergo an early neuro-cognitive rehabilitation program using the RehaCom software, which will be conducted at home. The goal is to improve the quality of life and care for patients through a multidisciplinary and innovative approach.

Eligibility criteria:
Inclusion Criteria:

* Adults (age ≥18 years)
* Both sexes
* Patients with rare brain tumors (incidence \<6 cases per 100,000 people/year)
* Candidates for craniotomy for rare brain tumors
* Native Italian speakers for cognitive and psychological evaluation and neuro-cognitive rehabilitation

Exclusion Criteria:

* Patients undergoing stereotactic/frameless biopsy
* Patients with psychiatric disorders or on psychotropic medications
* Patients with known cognitive decline (not due to the lesion)
* Patients admitted on the same day as the surgery
* Patients with severe impairments referred to rehabilitation centers
* Patients without a Windows PC or laptop with Internet connection for neuro-cognitive rehabilitation

Outcomes:
Symptoms/Signs Onset; Karnofsky Performance Status (KPS); Neurology Assessment in Neuro-Oncology (NANO); Modified Rankin Scale (mRS); American Society of Anesthesiologists (ASA); Charlson Comorbidity Index (CCI); Magnetic Resonance Imaging (MRI); Eloquent Area Involvement; Cranial Nerve Manipulation; Vascular Manipulation; Extent of Resection; Edema; Deep Location; Histology and Molecular Data; Preoperative Neurological Examination (EON); Tumor Side; Tumor Location; Cranial Nerve Status; Cognitive Data Collection: Phonemic Verbal Fluency; Cognitive Data Collection: Semantic Verbal Fluency; Cognitive Data Collection:Token Test; Cognitive Data Collection: Digit Span Forward and Backward; Cognitive Data Collection: Rey 15-Word List; Cognitive Data Collection: Rey Figure Reproduction; Cognitive Data Collection: Modified Taylor Complex Figure; Cognitive Data Collection:Trail Making Test; Cognitive Data Collection: Stroop Test; Cognitive Data Collection: Mini-Mental State Examination (MMSE); Cognitive Data Collection: Frontal Assessment Battery; Psychological and Quality of Life Data Collection: WHO Disability Assessment Schedule (WHODAS 2.0); Psychological and Quality of Life Data Collection: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30); Psychological and Quality of Life Data Collection: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Brain Neoplasms 20 (EORTC QLQ-BN20); Psychological and Quality of Life Data Collection: Hospital Anxiety and Depression Scale (HADS)