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| Name | Class |
|---|---|
| Centre Francois Baclesse | OTHER |
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Head and neck cancers are a source of complications and after-effects related to the disease and treatment. These cancers and their treatment alter the quality of life of patients and generate pain with physical and psychological components. Chronic pain affects 36% of patients at 6 months and 30% after this period. These pains are responsible for the consumption of level II and III analgesics in 53% of these patients. At the same time, after the end of treatment, nearly a quarter of patients continued to smoke and half still consumed alcohol at least twice a week.
The hypothesis of this research is to investigate the correlation between pain and the continuation of addictions, the occurrence of depressive states, asthenia and the alteration of the patients' global quality of life.
The investigators propose a two-center prospective cohort study to evaluate this hypothesis at 6 months after radiotherapy treatment.
This study is planned to include 120 patients with a first head and neck cancer whit radiotherapy as part of their treatment sequence. The expected duration of inclusion is 18 months.
The identification of factors affecting survival, quality of life and patient compliance is essential to determine appropriate management, particularly by creating appropriate therapeutic education programs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Population | Other | no arm, single cohort follow-up |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaire | Other | Self-questionnaires are completed by the patient at the time of this consultation:
Depending on the result of the NPSI questionnaire can be completed to better characterize neuropathic pain. Depending on the result of the HADS, the MADRS questionnaire can be completed to quantify the degree of depression. Individuals diagnosed with neuropathic pain or other depressive symptoms during the 6-month inclusion period will be referred to and managed by specialized practitioners. This assistance will be indicated in follow-up report |
| Measure | Description | Time Frame |
|---|---|---|
| change, neuropathic pain 1 | Neuropathic Pain Symptom Inventory (NPSI) questionnaire, score 0 to 10, higher scores mean a worse, score 0 to 100, higher scores mean a worse outcome | Day 0", "Month 6" |
| Measure | Description | Time Frame |
|---|---|---|
| change, anxiety/depression | with Hospital Anxiety and Depression Scale (HADS), score 0 to 21, higher scores mean a worse outcome | Day 0", "Month 6" |
| change, anxiety/depression 1 | Montgomery and Asberg Depression Scale (MADRS) questionnaire, score 0 to 60, higher scores mean a worse outcome |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maxime Humbert, MD | Contact | 0231064640 | +33 | humbert-m@chu-caen.fr |
| Emmanuel Babin, PHD | Contact | 0231064640 | +33 | babin-e@chu-caen.fr |
| Name | Affiliation | Role |
|---|---|---|
| maxime humbert, MD | University Hospital, Caen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Caen University Hospital | Recruiting | Caen | France |
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The main objective is to calculate the percentage of patients with neuropathic pain 6 months after the end of the treatments and to analyze the link between this pain and addictions, asthenia, depression, and in a more global way on the quality of life of patients. This evaluation will be done using validated questionnaires and self-questionnaires.
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|
| Day 0", "Month 6" |
| change, quality of life | QLQC30 questionnaire of Quality of Life, score 30-100, higher scores indicating better outcomes. the questionnaire measures several factors: physical fitness, professional activity, pain, nutrition, secondary effect, psychological and social status. | Day 0", "Month 6" |
| change, quality of life 1 | H&N43 questionnaire of Quality of Life, score 43 to 172, higher scores indicating a worse outcomes. The questionnaire measures several factors:secondary effect, self-image, sociability, sexuality. | Day 0", "Month 6" |
| change, fatigue | Multidimensional Fatigue Inventory (MFI-20) questionnaire, score 20 to 100, high scores represent more fatigue | Day 0", "Month 6" |
| change, symptoms related to head and neck cancer | MD Anderson Symptom Inventory Head and Neck (MDASI-HN) questionnaire, score 0 to 220, higher scores indicating more symptoms | Day 0", "Month 6" |
| change, sleep | question about sleep quality 0-10, higher scores indicating better outcomes | Day 0", "Month 6" |
| change, the impact of pain | short pain questionnaire in French (QCD), score 0 to 120, high scores represent more impact of pain | Day 0", "Month 6" |
| change, Alcohol Use and Consumption Disorder | Diagnostic and statistical manual of mental disorders (5th ed.) (DSM5) , questionnaire, score 0 to 115, high scores represent more disorder | Day 0", "Month 6" |
| change use of other psychoactive substances | Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) alcool questionnaire, score 0 to 39, high scores represent more addiction | Day 0", "Month 6" |
| change severity of nicotine addiction | Fagerström questionnaire, score 0 to 10, high scores represent more addiction | Day 0", "Month 6" |
| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D001008 | Anxiety Disorders |
| D059350 | Chronic Pain |
| D000437 | Alcoholism |
| D012816 | Signs and Symptoms |
| D014029 | Tobacco Use Disorder |
| D006258 | Head and Neck Neoplasms |
| D010146 | Pain |
| D016739 | Behavior, Addictive |
| D003863 | Depression |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D003192 | Compulsive Behavior |
| D007175 | Impulsive Behavior |
| D001519 | Behavior |
| D001526 | Behavioral Symptoms |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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