Cognitive Screening in Lung Cancer Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lung Disease
- Sponsor
- European Institute of Oncology
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- cognitive impairment
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
This study aims to investigate the occurrence of cancer and adjuvant therapy-related cognitive impairment in patients with both NSCLC and SCLC. The primary endpoint measure will be the presence of cognitive impairment during the first year after enrollment through the administration of a comprehensive neuropsychological assessment.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Small-cell and non-small-cell lung cancer (stage I, II, III, IV)
- •Age ≥ 18 years
- •Patients able to speak and read the local language(s) fluently
- •Acceptance and signature of informed consent
Exclusion Criteria
- •Presence of brain metastases
- •Patients with concomitant neurological or psychiatric disorders.
- •Patients undergoing brain radiotherapy
- •Previous diagnosis of lung cancer
Outcomes
Primary Outcomes
cognitive impairment
Time Frame: From baseline to 12 months
It will be the presence of cognitive impairment through the administration of a comprehensive neuropsychological assessment.Patient will complete cognitive evaluation which includes:the Montreal Cognitive Assessment and the Mini-Mental State Examination to assess global cognitive functioning;the Frontal Assessment Battery,the Stroop test color and word test ,and the Verbal Fluency Test for the evaluation of executive function;the Ray Auditory Verbal Learning Test for learning and memory;the forward and backward Digit Span and the Corsi Block-tapping Test for working memory;and the Trail Making Test A \& B and the Symbol Digit Modalities Test for attention. Classification will be obtained adopting the criteria proposed by the International Cognition and Cancer Task Force,a test score of 2 SDs or more below the test-specific reference cohort on at least 1 test of a cognitive domain.All test scores were transformed into z-scores to allow the comparison between different measures.
Secondary Outcomes
- Risk factors on the cognitive profile of lung cancer patients(From baseline to 12 months)