Telemedicine in the Management of Pain in Patients With Advanced or Metastatic Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Satisfaction of patients with advanced or metastatic pancreatic cancer of the impact of telemedicine in the management of their pain.
研究概览
简要总结
Adenocarcinoma of the pancreas is a major public health issue because of its disastrous prognosis. The symptomatology of locally advanced or metastatic forms, particularly painful, is often major and difficult to balance, impacting both the quality of life of patients (and those around them) and the course of treatment (chemotherapy).
The objective of this study is to evaluate the interest and feasibility of telemedicine in the management of pain in patients undergoing treatment for advanced or metastatic pancreatic cancer.
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
- •Patient ≥ 18 years old ;
- •Patient with histologically or cytologically proven locally advanced and/or metastatic adenocarcinoma of the pancreas;
- •Patient undergoing or failing medical treatment and comfort care only;
- •Patient with EVA ≥ 4 and/or requiring analgesics level 3;
- •Performans Status (ECOG) < 3 ;
- •Informing the patient and obtaining free, informed and written consent signed by the patient and the investigator;
- •Patient affiliated or beneficiary of the social security system
排除标准
- •Patient does not have a smartphone, tablet or computer;
- •Patient with no personal internet access at home (WIFI, wired), or via his smartphone;
- •Patient does not feel able to fill out an electronic questionnaire;
- •Patient cannot read or write French;
- •Patient does not speak and understand French;
- •Persons deprived of liberty or under guardianship or trusteeship ;
- •Dementia, mental alteration or psychiatric pathology that could compromise the patient's informed consent and/or compliance with the protocol and follow-up of the trial ;
- •Inability to submit to trial protocol follow-up for geographical, social, or other reasons ;
- •Patient participating in another interventional study evaluating treatment and pain management.
结局指标
主要结局
Satisfaction of patients with advanced or metastatic pancreatic cancer of the impact of telemedicine in the management of their pain.
时间窗: at one month, 3 months and 6 months post-inclusion
Satisfaction is measured using the Patient Global Clinical Impression of Change (P-GIC) questionnaire. The questionnaire consists of a single question posed to the patient via the application asking the patient what impact he or she believes telemedicine has had on the overall management of his or her pain. The patient has the following 8 propositions among which he must indicate the one that best corresponds to the perceived change: Don't know, Very strongly positive, Strongly positive, Slightly positive, No change, Slightly negative, Strongly negative, Very strongly negative.
次要结局
- Number of unscheduled hospitalizations recorded of each patient.(at 3 months and 6 months post-inclusion)
- Observed feasibility of telemedicine(3 months post-inclusion.)
- Satisfaction of healthcare professionals with the use of telemedicine in the management of patients' pain.(at 6 months post-inclusion)
- Number of "unscheduled" consultations recorded of each patient.(at 3 months and 6 months post-inclusion)