Cognition and Patients With Lung Cancer

NCT ID: NCT07160751

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2029-01-31

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.

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).

Conditions

Localized, Operable Non-small Cell Lung Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Surgery only

Self-questionnaire

Intervention Type: OTHER

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

Neoadjuvant treatment (chemotherapy or chemoimmunotherapy) followed by surgery

Cognitive tests

Intervention Type: OTHER

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

Surgery followed by adjuvant treatment (chemotherapy)

Assessment of the impact of social vulnerability on patient complaints

Intervention Type: OTHER

EPICES at month 12

Interventions

Self-questionnaire

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

Intervention Type: OTHER

Cognitive tests

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

Intervention Type: OTHER

Assessment of the impact of social vulnerability on patient complaints

EPICES at month 12

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Isabelle HARDY LEGER

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Hôpital Cochin - Service de pneumologie

Paris, Île-de-France Region, France

Countries

France

Central Contacts

Isabelle HARDY LEGER

Role: CONTACT

isabelle.leger@aphp.fr

01 58 41 24 01 ext. +33

Aline DECHANET, Project manager

Role: CONTACT

aline.dechanet@aphp.fr

Facility Contacts

Isabelle HARDY LEGER

Role: primary

isabelle.leger@aphp.fr

01 58 41 24 01 ext. +33

Other Identifiers

APHP250754

Identifier Type: -

Identifier Source: org_study_id