Cognition and Patients With Lung Cancer (COGNIPULM)

Observation of Cognitive Complaints in Patients With Localized, Operable Non-small Cell Lung Cancer

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Localized, Operable Non-small Cell Lung Cancer
• Intervention / Treatment: Other: Self-questionnaire; Other: Cognitive tests; Other: Assessment of the impact of social vulnerability on patient complaints

Detailed Description

Chemofog" is the term used to describe cognitive difficulties associated with cancer treatments, such as chemotherapy, radiotherapy, and surgery.

These difficulties may include problems with memory, executive functions, attention, orientation, verbal comprehension, and information processing speed, and can occur during and after treatment.

Although generally mild to moderate, they can limit patients' ability to return to work and manage daily tasks. These cognitive difficulties are often associated with mood changes and increased fatigue.

They significantly impair functional independence and quality of life for cancer patients.

A baseline assessment of cognitive function prior to treatment is essential. Various factors-such as age, medical or psychiatric history, social vulnerability, or other neurological and psychological risk factors-may preexist the cancer diagnosis.

Subsequently, the impact of the disease itself, the treatments, changes in socio-professional status, and increased or induced socioeconomic hardship, as well as psychological upheaval (such as receiving the diagnosis, anxiety, or family disruptions), may all lead to cognitive disturbances.

These disturbances, referred to as Cancer-Related Cognitive Impairment (CRCI), affect the quality of life of cancer survivors.

According to one study, 26% of lung cancer survivors present with CRCI.

Biological and genetic factors such as cellular senescence, inflammatory processes, and DNA damage are thought to play a role in the development of CRCI.

Current research seeks to identify relevant biomarkers of cognitive decline, such as cytokine levels, to better understand its mechanisms and improve its management.

Various risk factors for CRCI have been identified: advanced age, lower baseline cognitive functioning, and lack of physical activity.

Cognitive complaints have been recognized for more than 20 years and may affect up to 75% of cancer patients, regardless of cancer type.

Yet too few patients are informed of the existence of CRCI, even though awareness of these issues can directly impact their abilities-particularly in the professional sphere.

A French-language framework and international guidelines have been developed to help standardize cognitive assessment.

Nevertheless, the absence of methodological consensus on the selection of variables (biomarkers, cognitive tests, adjustment factors), measurements, analysis of results, and timing of evaluations leads to these difficulties being underdiagnosed.

Thus, further studies are needed to investigate this subject and ultimately implement appropriate management strategies.

Based on the recommendations of the Association Francophone des Soins Oncologiques de Support (AFSOS), which emphasize the importance of raising clinicians' awareness of the "chemofog/CRCI" issue-both to better define cognitive complaints and to propose appropriate management-our study aims to examine cognitive complaints in individuals diagnosed with confirmed, operable, localized non-small cell lung cancer (NSCLC).

• Study Type: Observational
• Enrollment (Estimated): 90

Contacts and Locations

• Study Contact: Name: Isabelle HARDY LEGER; Phone Number: +33 01 58 41 24 01; Email: isabelle.leger@aphp.fr
• Study Contact Backup: Name: Aline DECHANET, Project manager; Email: aline.dechanet@aphp.fr

Study Locations

• France
  • Île-de-France Region
    • Paris, Île-de-France Region, France
      • Hôpital Cochin - Service de pneumologie
      • Contact: Isabelle HARDY LEGER; Phone Number: +33 01 58 41 24 01; Email: isabelle.leger@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Known pre-existing cognitive disorders
• Presence on the day of inclusion of one or more factors causing mental confusion: electrolyte imbalances, renal failure, hepatic failure, infections, bladder distension, fecal impaction
• 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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Surgery only	Other: Self-questionnaire; FACT-Cog, HADS, FA12, EPICES, socio-professional and socio-demographic questionnaire
Neoadjuvant treatment (chemotherapy or chemoimmunotherapy) followed by surgery	Other: Cognitive tests; Hopkins Verbal Learning Test (HVLT). Trail Making Test (TMT). Verbal fluency test. Digit memory WAIS-IV.
Surgery followed by adjuvant treatment (chemotherapy)	Other: Assessment of the impact of social vulnerability on patient complaints; EPICES at month 12

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine whether there is a clinical and/or social phenotype associated with cognitive complaint.	Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) : min = 0, max=132	12 months
Determine whether there is a clinical and/or social phenotype associated with mood	Hospital Anxiety and Depression scale (HADS) : min=0, max=42	12 months
Determine whether there is a clinical and/or social phenotype associated with fatigue	European Organisation for Research and Treatment of Cancer - Fatigue Scale (EORTC QLQ-FA12) : min=0, max=100	12 months
Assessment of the impact of perioperative surgical and medical treatments on cognitive complaint	Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) : min=0, max=132	12 months
Assessment of the impact of perioperative surgical and medical treatments on mood.	Hospital Anxiety and Depression scale (HADS ): min=0, max=42	12 months
Assessment of the impact of perioperative surgical and medical treatments on fatigue.	European Organisation for Research and Treatment of Cancer - Fatigue Scale (EORTC QLQ-FA12) : min=0, max=100	12 months
Objective assessment via cognitive tests of the impact of cancer, treatments and co-factors on patients' cognition	Cognitive tests recommended by the International Cognition and Cancer Task Force (ICCTF) : Hopkins Verbal Learning Test (HVLT). Trail Making Test (TMT). Verbal fluency test. Digit memory WAIS-IV.	12 months
Assessment of the impact of social vulnerability on patient complaints	Assessment of Precarity and Health Inequalities in Health Examination Centers (EPICES): min = 0, max = 100.	12 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: URC-CIC Paris Descartes Necker Cochin
• Investigators: Principal Investigator: Isabelle HARDY LEGER, Hôpital Cochin, Assistance Publique-Hôpitaux de Paris - Service de pneumologie.

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: August 29, 2025
• First Submitted That Met QC Criteria: August 29, 2025
• First Posted (Estimated): September 8, 2025

Study Record Updates

• Last Update Posted (Actual): November 20, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: localized; Cognitive complaints; Operable non-small cell lung cancer,
• Additional Relevant MeSH Terms: Behavioral Disciplines and Activities; Psychological Tests; Neuropsychological Tests
• Other Study ID Numbers: APHP250754

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No