Cognition and Patients With Lung Cancer

NCT07160751 | Not Yet Recruiting

• 1 other identifier: APHP250754
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Cognitive complaints in patients treated for cancer can impact their quality of life. Studies show that these cognitive complaints may have multifactorial origins and appear at different stages of the care pathway. In a population of patients treated for confirmed localized non-small cell lung cancer (NSCLC), this study aims to detect and monitor the onset of cognitive complaints over time. The timing of the complaints during the treatment, the cognitive functions affected (memory, attention, concentration…), as well as the perceived intensity of the discomfort, will be examined. The study also explores the influence of co-factors such as mood, fatigue, socio-cultural status, and level of social vulnerability on these cognitive complaints.

Conditions

Localized, Operable Non-small Cell Lung Cancer

Keywords

localized; Operable non-small cell lung cancer,; Cognitive complaints

Outcome Measures

Primary Outcomes (1)

• To examine the onset, intensity and duration of the PCI (Perceived Cognitive Impairment) score

  Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) self-report questionnaire : min =0, max=132

  12 months

Secondary Outcomes (8)

• Determine whether there is a clinical and/or social phenotype associated with cognitive complaint.

  12 months

• Determine whether there is a clinical and/or social phenotype associated with mood

  12 months

• Determine whether there is a clinical and/or social phenotype associated with fatigue

  12 months

• Assessment of the impact of perioperative surgical and medical treatments on cognitive complaint

  12 months

• Assessment of the impact of perioperative surgical and medical treatments on mood.

  12 months

Study Arms (3)

Surgery only

Other: Self-questionnaire

Neoadjuvant treatment (chemotherapy or chemoimmunotherapy) followed by surgery

Other: Cognitive tests

Surgery followed by adjuvant treatment (chemotherapy)

Other: Assessment of the impact of social vulnerability on patient complaints

Interventions

Self-questionnaire OTHER

FACT-Cog, HADS, FA12, EPICES, socio-professional and socio-demographic questionnaire

Surgery only

Cognitive tests OTHER

Hopkins Verbal Learning Test (HVLT). Trail Making Test (TMT). Verbal fluency test. Digit memory WAIS-IV.

Neoadjuvant treatment (chemotherapy or chemoimmunotherapy) followed by surgery

Assessment of the impact of social vulnerability on patient complaints OTHER

EPICES at month 12

Surgery followed by adjuvant treatment (chemotherapy)

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The target population includes adults aged 18 to 74 years with suspected localized and operable non-small cell lung cancer. Patients whose cancer diagnosis is not confirmed after inclusion will be prematurely withdrawn from the study

You may qualify if:

• Adult patient aged 18 to 74 years
• Suspected or confirmed localized and operable non-small cell lung cancer (NSCLC)
• Surgical treatment with or without perioperative systemic medical therapy
• Ability to independently complete self-questionnaires via the Cleanweb platform
• Patients with access to a phone, tablet, or computer at home to complete the electronic self-questionnaires.

You may not qualify if:

• Known pre-existing cognitive disorders
• Known psychiatric or neurological diseases (e.g., multiple sclerosis, Parkinson's disease, dementia, stroke, traumatic brain injury with loss of consciousness)
• Current use of neuroleptic treatments
• History of cancer treatment within the past 10 years
• Fibromyalgia
• Individuals who cannot read French or are not French-speaking
• Patients who have never attended school

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hôpital Cochin - Service de pneumologie

Paris, Île-de-France Region, France

Location

MeSH Terms

Interventions

Neuropsychological Tests

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Isabelle HARDY LEGER

  Hôpital Cochin, Assistance Publique-Hôpitaux de Paris - Service de pneumologie.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabelle HARDY LEGER

CONTACT

01 58 41 24 01; isabelle.leger@aphp.fr

Aline DECHANET, Project manager

CONTACT

aline.dechanet@aphp.fr

Study Design

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

Study Record Dates

• First Submitted: August 29, 2025
• First Posted: September 8, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: November 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)