Vulnerability and Risk of Neuropathic Pain in Cancer
NCT Number: NCT06511674
Acronym: CANOPY
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Neuropathic Pain|Cancer|Predictive
Interventions: OTHER: Cognitive-emotional and pain assessments
Sponsor: University Hospital, Clermont-Ferrand
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 625
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
Start Date: 2024-09-02
Completion Date: 2028-06-30
Locations: CHU de Clermont-Ferrand, Clermont-Ferrand, 63000, France|Nstitut Godinot, Reims, France|Centre Hospitalier Yves Le Foll, Saint Brieuc, France|CH Valenciennes, Valenciennes, France

Summary:
Successive and repeated therapeutic interventions during cancer management - surgery, chemotherapy, radiotherapy - can all, to varying degrees, generate acute pain, central pain sensitization and chronic pain. Almost 58% of patients suffer from chronic pain, often of the neuropathic type, with altered quality of life and disease burden amplified by difficulty in achieving effective relief.

Indeed, neuropathic pain in cancer remains difficult to treat, often arrives insidiously, may persist well beyond cancer remission, and frequently has a fate that is difficult to predict. Current treatments for neuropathic pain are based on the recommendations of learned societies, but therapeutic failures are frequent, and iatrogenic pathology is high. Many factors have been identified as being associated with the development of chronic pain in cancer patients. The intensity of preoperative pain, opioid consumption, age, sleep disorders, cognitive-emotional state, psychological vulnerability and social precariousness are all factors that influence and perpetuate chronic pain linked to cancer and its management. Several studies have shown that 6 months or 1 year after cancer diagnosis, there are various pain trajectories, enabling us to identify several pain patient phenotypes. The patient's overall state of vulnerability at the time of cancer diagnosis has an impact on the trajectory of pain chronicisation, and it is often difficult for clinicians to apprehend this risk. In practice, we lack a validated, easy-to-use tool that would enable us to predict the risk of pain chronicisation for each patient, even before the start of the treatment process.

Primary Outcome Measures: CANoPy score (Z-score), Calculation of the CANoPy score (Z-score) predictive of the development of neuropathic pain.

The z-scores are then averaged across endpoints for each patient., Baseline|CANoPy score (Z-score), Calculation of the CANoPy score (Z-score) predictive of the development of neuropathic pain.

The z-scores are then averaged across endpoints for each patient., 6 months|CANoPy score (Z-score), Calculation of the CANoPy score (Z-score) predictive of the development of neuropathic pain.

The z-scores are then averaged across endpoints for each patient., 12 months
Secondary Outcome Measures: Pain assessment using the Numerical Pain Scale (EN), Numerical Pain Scale (EN): This numerical scale provides a pain assessment from 0 to 10., Baseline|Pain assessment using the Neuropathic Pain Questionnaire (DN4), Neuropathic Pain (DN4): This questionnaire estimates the probability of neuropathic pain in a patient, by means of four questions divided into ten items to be ticked. The practitioner or clinical research associate in charge of the study interviews or examines the patient and fills in the questionnaire himself. Each item is marked with a "yes" or "no" answer. Each "yes" is worth a score of 1, and each "no" is worth a score of 0. The sum of the scores gives the patient's score (out of 10); if the patient's score is equal to or greater than 4/10, the test is positive., Baseline|Pain assessment using the Numerical Pain Scale (EN), Numerical Pain Scale (EN): This numerical scale provides a pain assessment from 0 to 10., 6 months|Pain assessment using the Neuropathic Pain Questionnaire (DN4), Neuropathic Pain (DN4): This questionnaire estimates the probability of neuropathic pain in a patient, by means of four questions divided into ten items to be ticked. The practitioner or clinical research associate in charge of the study interviews or examines the patient and fills in the questionnaire himself. Each item is marked with a "yes" or "no" answer. Each "yes" is worth a score of 1, and each "no" is worth a score of 0. The sum of the scores gives the patient's score (out of 10); if the patient's score is equal to or greater than 4/10, the test is positive., 6 months|Pain assessment using the Numerical Pain Scale (EN), Numerical Pain Scale (EN): This numerical scale provides a pain assessment from 0 to 10., 12 months|Pain assessment using the Neuropathic Pain Questionnaire (DN4), Neuropathic Pain (DN4): This questionnaire estimates the probability of neuropathic pain in a patient, by means of four questions divided into ten items to be ticked. The practitioner or clinical research associate in charge of the study interviews or examines the patient and fills in the questionnaire himself. Each item is marked with a "yes" or "no" answer. Each "yes" is worth a score of 1, and each "no" is worth a score of 0. The sum of the scores gives the patient's score (out of 10); if the patient's score is equal to or greater than 4/10, the test is positive., 12 months|Assessment of cognitive status using the Functional Assessment of Cancer Therapy - Cognitive Function (FACT-COG) questionnaire, Functional Assessment of Cancer Therapy COGnitive function (FACT-COG): The Functional Assessment of Cancer Therapy-COGnitive function, known as FACT-COG, is a 37-item self-report questionnaire of perceived cognitive impairment. It assesses mental acuity, attention and concentration, memory, verbal fluency, functional interference, deficits observed by others, changes from previous functioning and impact on quality of life. These items were developed on the basis of interviews with cancer patients and their carers. The FACT-COG has been validated in a study of cancer patients., Baseline|Assessment of cognitive status using the Functional Assessment of Cancer Therapy - Cognitive Function (FACT-COG) questionnaire, Functional Assessment of Cancer Therapy COGnitive function (FACT-COG): The Functional Assessment of Cancer Therapy-COGnitive function, known as FACT-COG, is a 37-item self-report questionnaire of perceived cognitive impairment. It assesses mental acuity, attention and concentration, memory, verbal fluency, functional interference, deficits observed by others, changes from previous functioning and impact on quality of life. These items were developed on the basis of interviews with cancer patients and their carers. The FACT-COG has been validated in a study of cancer patients., 6 months|Assessment of cognitive status using the Functional Assessment of Cancer Therapy - Cognitive Function (FACT-COG) questionnaire, Functional Assessment of Cancer Therapy COGnitive function (FACT-COG): The Functional Assessment of Cancer Therapy-COGnitive function, known as FACT-COG, is a 37-item self-report questionnaire of perceived cognitive impairment. It assesses mental acuity, attention and concentration, memory, verbal fluency, functional interference, deficits observed by others, changes from previous functioning and impact on quality of life. These items were developed on the basis of interviews with cancer patients and their carers. The FACT-COG has been validated in a study of cancer patients., 12 months|Assessment of emotional status using the Anxiety and Depression Scale (HAD), The Hospital Anxiety Depression (HAD) scale is a 14-item self-administered questionnaire completed by the patient. These items are divided into two subscales: 7 items to assess depression and 7 items to assess anxiety., Baseline|Assessment of emotional status using the Anxiety and Depression Scale (HAD), The Hospital Anxiety Depression (HAD) scale is a 14-item self-administered questionnaire completed by the patient. These items are divided into two subscales: 7 items to assess depression and 7 items to assess anxiety., 6 months|Assessment of emotional status using the Anxiety and Depression Scale (HAD), The Hospital Anxiety Depression (HAD) scale is a 14-item self-administered questionnaire completed by the patient. These items are divided into two subscales: 7 items to assess depression and 7 items to assess anxiety., 12 months|Evaluation of social vulnerability using the questionnaire Evaluation of Deprivation and Inequalities in Health Examination Centres (EPICES), The Evaluation of Deprivation and Inequalities in Health Examination Centres (EPICES) questionnaire consists of 11 binary questions (yes/no) used to calculate an individual score indicating precariousness and health inequalities ranging from 0 to 100., Baseline|Evaluation of social vulnerability using the questionnaire Evaluation of Deprivation and Inequalities in Health Examination Centres (EPICES), The Evaluation of Deprivation and Inequalities in Health Examination Centres (EPICES) questionnaire consists of 11 binary questions (yes/no) used to calculate an individual score indicating precariousness and health inequalities ranging from 0 to 100., 6 months|Evaluation of social vulnerability using the questionnaire Evaluation of Deprivation and Inequalities in Health Examination Centres (EPICES), The Evaluation of Deprivation and Inequalities in Health Examination Centres (EPICES) questionnaire consists of 11 binary questions (yes/no) used to calculate an individual score indicating precariousness and health inequalities ranging from 0 to 100., 12 months|Assessment of quality of life using the EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30), EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30) : The self-reported EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30) is used as a tool to measure the (health-related) quality of life of cancer patients. This tool is used to assess their own level of functioning in different areas of quality of life.The questionnaire comprises 9 subscales, each consisting of several items: 5 subscales measuring functional status, 3 symptom subscales, and an overall subscale measuring quality of life and state of health., Baseline|Assessment of quality of sleep using the Pittsburgh Sleep Quality Index (PSQI), Pittsburg Sleep Quality Index (PSQI): The Pittsburg Sleep Quality Index (PSQI) is a self-administered questionnaire comprising 19 items. It was developed to measure sleep quality in the month preceding the patient interview. The questionnaire has 7 components: subjective sleep quality, sleep latency, sleep duration, usual sleep efficiency, sleep disturbance, use of sleep medication and poor daytime sleepiness., Baseline|Assessment of quality of life using the EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30), EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30) : The self-reported EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30) is used as a tool to measure the (health-related) quality of life of cancer patients. This tool is used to assess their own level of functioning in different areas of quality of life.The questionnaire comprises 9 subscales, each consisting of several items: 5 subscales measuring functional status, 3 symptom subscales, and an overall subscale measuring quality of life and state of health., 6 months|Assessment of quality of sleep using the Pittsburgh Sleep Quality Index (PSQI), Pittsburg Sleep Quality Index (PSQI): The Pittsburg Sleep Quality Index (PSQI) is a self-administered questionnaire comprising 19 items. It was developed to measure sleep quality in the month preceding the patient interview. The questionnaire has 7 components: subjective sleep quality, sleep latency, sleep duration, usual sleep efficiency, sleep disturbance, use of sleep medication and poor daytime sleepiness., 6 months|Assessment of quality of life using the EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30), EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30) : The self-reported EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30) is used as a tool to measure the (health-related) quality of life of cancer patients. This tool is used to assess their own level of functioning in different areas of quality of life.The questionnaire comprises 9 subscales, each consisting of several items: 5 subscales measuring functional status, 3 symptom subscales, and an overall subscale measuring quality of life and state of health., 12 months|Assessment of quality of sleep using the Pittsburgh Sleep Quality Index (PSQI), Pittsburg Sleep Quality Index (PSQI): The Pittsburg Sleep Quality Index (PSQI) is a self-administered questionnaire comprising 19 items. It was developed to measure sleep quality in the month preceding the patient interview. The questionnaire has 7 components: subjective sleep quality, sleep latency, sleep duration, usual sleep efficiency, sleep disturbance, use of sleep medication and poor daytime sleepiness., 12 months|Assessment of disease perception and beliefs using the Illness Perception Questionnaire Revised (IPQ-R), Illness Perception Questionnaire Revised (IPQ-R): The Illness Perception Questionnaire Revised (IPQ-R) is a self-administered questionnaire which assesses representations of the illness. It consists of 70 items divided into three categories: vision of the illness, point of view of the illness and causes of the illness., Baseline|Assessment of disease perception and beliefs using the disease-specific Cancer Locus of Control Scale (CLCS), Cancer Locus of Control Scale (CLCS): This 17-item disease-specific controllability scale has been validated in a French population of breast cancer patients and is used to measure the perception of control over serious chronic illness and cancer. The items are rated using a four-point Likert scale (from 1 "strongly disagree" to 4 "strongly agree"). The items are divided into three subscales: perceived control over the course of the disease, internal causal attribution, and religious control., Baseline|Assessment of disease perception and beliefs using the Illness Perception Questionnaire Revised (IPQ-R), Illness Perception Questionnaire Revised (IPQ-R): The Illness Perception Questionnaire Revised (IPQ-R) is a self-administered questionnaire which assesses representations of the illness. It consists of 70 items divided into three categories: vision of the illness, point of view of the illness and causes of the illness., 6 months|Assessment of disease perception and beliefs using the disease-specific Cancer Locus of Control Scale (CLCS), Cancer Locus of Control Scale (CLCS): This 17-item disease-specific controllability scale has been validated in a French population of breast cancer patients and is used to measure the perception of control over serious chronic illness and cancer. The items are rated using a four-point Likert scale (from 1 "strongly disagree" to 4 "strongly agree"). The items are divided into three subscales: perceived control over the course of the disease, internal causal attribution, and religious control., 6 months|Assessment of disease perception and beliefs using the Illness Perception Questionnaire Revised (IPQ-R), Illness Perception Questionnaire Revised (IPQ-R): The Illness Perception Questionnaire Revised (IPQ-R) is a self-administered questionnaire which assesses representations of the illness. It consists of 70 items divided into three categories: vision of the illness, point of view of the illness and causes of the illness., 12 months|Assessment of disease perception and beliefs using the disease-specific Cancer Locus of Control Scale (CLCS), Cancer Locus of Control Scale (CLCS): This 17-item disease-specific controllability scale has been validated in a French population of breast cancer patients and is used to measure the perception of control over serious chronic illness and cancer. The items are rated using a four-point Likert scale (from 1 "strongly disagree" to 4 "strongly agree"). The items are divided into three subscales: perceived control over the course of the disease, internal causal attribution, and religious control., 12 months|Assessment of analgesic consumption, Assessment of analgesic consumption throughout the study., Baseline|Assessment of analgesic consumption, Assessment of analgesic consumption throughout the study., 6 months|Assessment of analgesic consumption, Assessment of analgesic consumption throughout the study., 12 months