Cognitive Screening in Lung Cancer Patients

NCT06727370 | Recruiting

• 1 other identifier: IEO 2027
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Disease; NSCLC (Non-small Cell Lung Cancer); SCLC

Keywords

lung cancer; nsclc; sclc; cognitive

Outcome Measures

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.

  From baseline to 12 months

Secondary Outcomes (1)

• Risk factors on the cognitive profile of lung cancer patients

  From baseline to 12 months

Study Arms (1)

patients diagnosed with lung cancer

patients diagnosed with lung cancer (both SCLC and NSCLC)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients diagnosed with lung cancer (both SCLC and NSCLC)

You may qualify if:

• 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

You may not qualify if:

• Age ≥ 70
• Presence of brain metastases
• Patients with concomitant neurological or psychiatric disorders.
• Patients undergoing brain radiotherapy
• Previous diagnosis of lung cancer

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (1)

Istituto Europeo di Oncologia

Milan, 20141, Italy

RECRUITING

MeSH Terms

Conditions

Lung Diseases; Carcinoma, Non-Small-Cell Lung; Lung Neoplasms; Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• Gabriella Pravettoni

  Istituto Europeo di Oncologia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriella Pravettoni

CONTACT

+39025489731; gabriella.pravettoni@ieo.it

Lorenzo Conti

CONTACT

+390257489731

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: December 10, 2024
• Study Start: January 10, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 10, 2024

Record last verified: 2024-11

Locations

IT (1)