Predictive and Impact of Pain at 6 Months in Patients Treated With Radiotherapy for Head and Neck Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- change, neuropathic pain 1
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a first Head and neck cancer whose therapeutic sequence involves radiotherapy
- •Patient over 18 years of age
- •Having given written consent
- •patient not previously treated with radiotherapy
- •Life expectancy > 3 months
- •World Health Organization (WHO) score < 3
- •Histologically proven Head and Neck cancer
- •Stable patient, with no signs of recurrence or other progressive neoplasia at the time of the examination
- •Patient treated with radiotherapy
- •Patient fluent in French
排除标准
- •Non-consenting patient
- •History of malignancy, other than treated and cured basal cell or cervical cancer
- •Patient who has had a salvage surgery other than lymph node removal
- •Patient with evidence of recurrence or other progressive neoplasia at the time of examination
- •Patient who has had previous mutilating surgery (causing sequelae of swallowing and eating)
- •Uncontrolled infectious pathology
- •Patient under 18 years of age
- •Patient who is not fluent in French
- •Patient with a psychiatric pathology that could disrupt the study or prevent the interpretation of the results.
研究组 & 干预措施
Population
no arm, single cohort follow-up
干预措施: Questionnaire (Other)
结局指标
主要结局
change, neuropathic pain 1
时间窗: Day 0", "Month 6"
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
次要结局
- change, quality of life(Day 0", "Month 6")
- change, sleep(Day 0", "Month 6")
- change, the impact of pain(Day 0", "Month 6")
- change, symptoms related to head and neck cancer(Day 0", "Month 6")
- change, Alcohol Use and Consumption Disorder(Day 0", "Month 6")
- change use of other psychoactive substances(Day 0", "Month 6")
- change, anxiety/depression(Day 0", "Month 6")
- change, anxiety/depression 1(Day 0", "Month 6")
- change severity of nicotine addiction(Day 0", "Month 6")
- change, quality of life 1(Day 0", "Month 6")
- change, fatigue(Day 0", "Month 6")