Cognitive Screening in Lung Cancer Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorEuropean Institute of Oncology
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Age ≥ 70
Presence of brain metastases
Patients with concomitant neurological or psychiatric disorders.
Patients undergoing brain radiotherapy
Trial population
patients diagnosed with lung cancer (both SCLC and NSCLC)
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
200 Participants
are grouped into 1 trial groupGroup A: patients diagnosed with lung cancer
Trial outcomes
Primary outcomes
1
cognitive impairment
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.
Time frame
From baseline to 12 monthsSecondary outcomes
1
Risk factors on the cognitive profile of lung cancer patients
This study will assess the influence of different risk factors on the cognitive profile of lung cancer patients. It will examine the role of psychological symptoms through different self-reported questionnaire: the Functional Assessment of Cancer Therapy - cognition will be administered to assess perceived cognitive impairment, the Beck Depression Inventory II to measure the presence of depressive symptoms, the State-Trait Anxiety Inventory to investigate both state anxiety and trait anxiety, the EORTC-Quality of Life of cancer patient to assess the quality of life and, finally, the Pittsburgh Sleep Quality Index to evaluate sleep quality and disturbances sleep patterns. Finally, the Cognitive Reserve Index questionnaire will be administered to obtain the cognitive reserve level of each patient, and the smoking information obtained through an interview.All the questionnaire scores were transformed into z-scores to allow the comparison between different measures.
Time frame
From baseline to 12 monthsSponsors and contacts
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Source ClinicalTrials.gov