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NCT Number: NCT06727370

Cognitive Screening in Lung Cancer Patients

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Europeo di Oncologia

Milan, 20141, Italy

Location status: Recruiting

Location contact

Gabriella Pravettoni

CONTACT

[email protected]

+390257489731

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Primary outcomes

  1. 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

  1. Risk factors on the cognitive profile of lung cancer patients

    Time frame: From baseline to 12 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Gabriella Pravettoni

CONTACT

[email protected]

+39025489731

Lorenzo Conti

CONTACT

+390257489731

Sponsors and collaborators

Lead sponsor

European Institute of Oncology

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 10, 2024
Registry last updated
Dec 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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