Evaluation of the Impact of a Coordinating Nurse in a Personalized Care Program on Quality of Care, Coordination of the Actors and on Quality of Life for Patients With Lung Cancer. A French Randomized Monocentric Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Impact of the coordinating nurse on quality of care measured by the variation of timelines in personalized care
研究概览
简要总结
The prognosis of patients with lung cancer is related to the stage of the diagnosis : 73% of one-year-survival rate at stage IA and only 13% one-year-survival rate at stage IV. Controlling the timelines in a care program seems crucial to improve prognosis of lung cancer.
The project aims to evaluate the impact of a coordinating nurse (CN) in a personalized care program for patients of thoracic oncology.
详细描述
New strategies therapeutics result in a longer survival rate. However their side effects affect the patient's quality of life. Even if these side effects are ambulatory manageable, they require to be treated promptly and tends to increase the active list of patients of the thoracic oncology.
Due to the alteration in the care provided to lung cancer patient, there is a need to coordinate the available means, inside and outside the hospital, to improve the quality of care and the quality of life of the patient.
Every patient of the thoracic oncology department receives a personalized care program as a routine practice. In this study, a coordinating nurse (CN) will be added to the personalized care program. Patients newly diagnosed with a lung cancer will be randomized either in the group with a CN or in the group without a CN.
The study will last one year maximum for each participant. Their quality of life, their satisfaction of the quality of the personalized care program - and their general practitioner's satisfaction - will be evaluated throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 of the thoracic oncology ward between April and November 2016
- •Newly diagnosed lung cancer
- •Treated in the pneumology ward of the Mulhouse Hospital (France)
- •Patient enrolled in another clinical trial can also be enrolled in this study
- •Patients who have not disagreed to participate to the study
排除标准
- •Secondary cancer in lung
- •Relapse of primary cancer in lung of the same histological type
- •Previous enrollment in this study
- •Uncontrolled psychological problem
研究组 & 干预措施
Coordinating nurse added to the personalized care program
The coordinating nurse (CN) is dedicated to the newly diagnosed patient to optimize their personalized care program.
- The CN is the connection between the medical team and the patient. They act according to the instructions from the multidisciplinary staff in charge of bronchopulmonary cancer patients.:
e.g. Schedule an exam or an hospitalization, collect and share results of useful information to correct treatment's side effects etc
- Main contact of the patient, the general practitioner and the patient's relatives, they give practical information for the patient's case
- Quality of life questionnaires - EORTC QLQ-C30 and EORTC QLQ-LC13 - completed by the patient throughout the study.
- 2 Satisfaction questionnaires completed :
- satisfaction questionnaire - patient,
- satisfaction questionnaire - general practitioner or home nurse
干预措施: EORTC QLQ-C30 (Behavioral)
Coordinating nurse added to the personalized care program
The coordinating nurse (CN) is dedicated to the newly diagnosed patient to optimize their personalized care program.
- The CN is the connection between the medical team and the patient. They act according to the instructions from the multidisciplinary staff in charge of bronchopulmonary cancer patients.:
e.g. Schedule an exam or an hospitalization, collect and share results of useful information to correct treatment's side effects etc
- Main contact of the patient, the general practitioner and the patient's relatives, they give practical information for the patient's case
- Quality of life questionnaires - EORTC QLQ-C30 and EORTC QLQ-LC13 - completed by the patient throughout the study.
- 2 Satisfaction questionnaires completed :
- satisfaction questionnaire - patient,
- satisfaction questionnaire - general practitioner or home nurse
干预措施: Satisfaction questionnaire - patient (Behavioral)
Coordinating nurse added to the personalized care program
The coordinating nurse (CN) is dedicated to the newly diagnosed patient to optimize their personalized care program.
- The CN is the connection between the medical team and the patient. They act according to the instructions from the multidisciplinary staff in charge of bronchopulmonary cancer patients.:
e.g. Schedule an exam or an hospitalization, collect and share results of useful information to correct treatment's side effects etc
- Main contact of the patient, the general practitioner and the patient's relatives, they give practical information for the patient's case
- Quality of life questionnaires - EORTC QLQ-C30 and EORTC QLQ-LC13 - completed by the patient throughout the study.
- 2 Satisfaction questionnaires completed :
- satisfaction questionnaire - patient,
- satisfaction questionnaire - general practitioner or home nurse
干预措施: Satisfaction questionnaire - general practitioner or home nurse (Behavioral)
Coordinating nurse added to the personalized care program
The coordinating nurse (CN) is dedicated to the newly diagnosed patient to optimize their personalized care program.
- The CN is the connection between the medical team and the patient. They act according to the instructions from the multidisciplinary staff in charge of bronchopulmonary cancer patients.:
e.g. Schedule an exam or an hospitalization, collect and share results of useful information to correct treatment's side effects etc
- Main contact of the patient, the general practitioner and the patient's relatives, they give practical information for the patient's case
- Quality of life questionnaires - EORTC QLQ-C30 and EORTC QLQ-LC13 - completed by the patient throughout the study.
- 2 Satisfaction questionnaires completed :
- satisfaction questionnaire - patient,
- satisfaction questionnaire - general practitioner or home nurse
干预措施: EORTC QLQ-LC13 (Behavioral)
Personalized care program as routine practice
A personalized care program is decided for the newly diagnosed patient by the multidisciplinary team in charge of lung cancer.
The care provided will be organized by the medical team, and besides the oncologist, no principal coordinating contact will be in charge of the patient.
The quality of life questionnaire - EORTC QLQ-C30 and QLQ-LC13 - will be completed by the patient throughout the study.
- 2 Satisfaction questionnaires completed :
- satisfaction questionnaire - patient,
- satisfaction questionnaire - general practitioner or home nurse
干预措施: EORTC QLQ-C30 (Behavioral)
Personalized care program as routine practice
A personalized care program is decided for the newly diagnosed patient by the multidisciplinary team in charge of lung cancer.
The care provided will be organized by the medical team, and besides the oncologist, no principal coordinating contact will be in charge of the patient.
The quality of life questionnaire - EORTC QLQ-C30 and QLQ-LC13 - will be completed by the patient throughout the study.
- 2 Satisfaction questionnaires completed :
- satisfaction questionnaire - patient,
- satisfaction questionnaire - general practitioner or home nurse
干预措施: Satisfaction questionnaire - patient (Behavioral)
Personalized care program as routine practice
A personalized care program is decided for the newly diagnosed patient by the multidisciplinary team in charge of lung cancer.
The care provided will be organized by the medical team, and besides the oncologist, no principal coordinating contact will be in charge of the patient.
The quality of life questionnaire - EORTC QLQ-C30 and QLQ-LC13 - will be completed by the patient throughout the study.
- 2 Satisfaction questionnaires completed :
- satisfaction questionnaire - patient,
- satisfaction questionnaire - general practitioner or home nurse
干预措施: Satisfaction questionnaire - general practitioner or home nurse (Behavioral)
Personalized care program as routine practice
A personalized care program is decided for the newly diagnosed patient by the multidisciplinary team in charge of lung cancer.
The care provided will be organized by the medical team, and besides the oncologist, no principal coordinating contact will be in charge of the patient.
The quality of life questionnaire - EORTC QLQ-C30 and QLQ-LC13 - will be completed by the patient throughout the study.
- 2 Satisfaction questionnaires completed :
- satisfaction questionnaire - patient,
- satisfaction questionnaire - general practitioner or home nurse
干预措施: EORTC QLQ-LC13 (Behavioral)
结局指标
主要结局
Impact of the coordinating nurse on quality of care measured by the variation of timelines in personalized care
时间窗: At visit 1, around 1 month after the beginning of the study
Variation of the time between the first appointment with the thoracic oncologist and the first day of anticancer therapy
次要结局
- Analysis of the feedback from the patient(Around 3 and around 6 and around 12 months after beginning of study)
- Analysis of the feedback from healthcare professionals outside the thoracic oncology ward(6 months after the beginning of the study)
- Impact of a coordinating nurse in a personalized care program on the patient's quality of life(At study enrollment, then around 3 and around 6 and around 12 months later)