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| Name | Class |
|---|---|
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgery only |
| ||
| Neoadjuvant treatment (chemotherapy or chemoimmunotherapy) followed by surgery |
| ||
| Surgery followed by adjuvant treatment (chemotherapy) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-questionnaire | Other | FACT-Cog, HADS, FA12, EPICES, socio-professional and socio-demographic questionnaire |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Isabelle HARDY LEGER | Contact | 01 58 41 24 01 | +33 | isabelle.leger@aphp.fr |
| Aline DECHANET, Project manager | Contact | aline.dechanet@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Isabelle HARDY LEGER | Hôpital Cochin, Assistance Publique-Hôpitaux de Paris - Service de pneumologie. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Cochin - Service de pneumologie | Paris | Île-de-France Region | France |
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| ID | Term |
|---|---|
| D009483 | Neuropsychological Tests |
| ID | Term |
|---|---|
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |
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| Cognitive tests | Other | Hopkins Verbal Learning Test (HVLT). Trail Making Test (TMT). Verbal fluency test. Digit memory WAIS-IV. |
|
| Assessment of the impact of social vulnerability on patient complaints | Other | EPICES at month 12 |
|
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 |