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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Lung Cancer

Intervention / Treatment
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* Behavioral: EORTC QLQ-C30
* Behavioral: Satisfaction questionnaire - patient
* Behavioral: Satisfaction questionnaire - general practitioner or home nurse
* Behavioral: EORTC QLQ-LC13


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Secondary cancer in lung Relapse of primary cancer in lung of the same histological type Previous enrollment in this study Uncontrolled psychological problem

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Coordinating nurse added to the personalized care program<br>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 | Behavioral: EORTC QLQ-C30<br>* Questionnaire submitted at the beginning of the study. Then three more times : 3, 6 and 12 months after the start of anti-cancer therapy. The questionnaire can also be completed before the 12th month: when the care program is about to end<br>* Other names: The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire;Behavioral: Satisfaction questionnaire - patient<br>* The patient will fill in a satisfaction questionnaire three times : around the third, the sixth and the twelfth month after they started an anti-cancer therapy.<br>Behavioral: Satisfaction questionnaire - general practitioner or home nurse<br>* The general practitioner or the nurse in charge of the patient at home will fill in a satisfaction questionnaire six months after the patient started an anti-cancer therapy.<br>Behavioral: EORTC QLQ-LC13<br>* Questionnaire submitted at the beginning of the study. Then three more times : 3, 6 and 12 months after the start of anti-cancer therapy. The questionnaire can also be completed before the 12th month: when the care program is about to end<br>* Other names: The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer;|
| Active Comparator: Personalized care program as routine practice<br>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 | Behavioral: EORTC QLQ-C30<br>* Questionnaire submitted at the beginning of the study. Then three more times : 3, 6 and 12 months after the start of anti-cancer therapy. The questionnaire can also be completed before the 12th month: when the care program is about to end<br>* Other names: The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire;Behavioral: Satisfaction questionnaire - patient<br>* The patient will fill in a satisfaction questionnaire three times : around the third, the sixth and the twelfth month after they started an anti-cancer therapy.<br>Behavioral: Satisfaction questionnaire - general practitioner or home nurse<br>* The general practitioner or the nurse in charge of the patient at home will fill in a satisfaction questionnaire six months after the patient started an anti-cancer therapy.<br>Behavioral: EORTC QLQ-LC13<br>* Questionnaire submitted at the beginning of the study. Then three more times : 3, 6 and 12 months after the start of anti-cancer therapy. The questionnaire can also be completed before the 12th month: when the care program is about to end<br>* Other names: The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of the coordinating nurse on quality of care measured by the variation of timelines in personalized care | Variation of the time between the first appointment with the thoracic oncologist and the first day of anticancer therapy | At visit 1, around 1 month after the beginning of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of the feedback from healthcare professionals outside the thoracic oncology ward | Measured by satisfaction questionnaires submitted to general practitioner or home nurse | 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 | Evolution of the scoring results of the EORTC QLQ-C30 | At the beginning of the study, then around 3, around 6 and around 12 months later | 
| Impact of a coordinating nurse in a personalized care program on the patient's quality of life | Evolution of the scoring results of the EORTC QLQ-LC13 | At study enrollment, then around 3 and around 6 and around 12 months later | 
| Analysis of the feedback from the patient | Measured by satisfaction questionnaires submitted to the patient | Around 3 and around 6 and around 12 months after beginning of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coordinating nurse of thoracic oncology, quality of care in thoracic oncology, lung cancer quality of life