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 (EVIDEC)

Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

Status: Completed

Conditions: Lung Cancer

Treatments: Behavioral: Satisfaction questionnaire - general practitioner or home nurse; Behavioral: EORTC QLQ-LC13; Behavioral: EORTC QLQ-C30; Behavioral: Satisfaction questionnaire - patient

Study type: Interventional

Funder types: Other

Identifiers

NCT02822209

804

2015-A01660-49 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 59 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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59 participants in 2 patient groups

Coordinating nurse added to the personalized care program

Experimental group

Description:

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

Treatment:

Behavioral: EORTC QLQ-C30

Behavioral: Satisfaction questionnaire - general practitioner or home nurse

Behavioral: EORTC QLQ-LC13

Behavioral: Satisfaction questionnaire - patient

Personalized care program as routine practice

Active Comparator group

Description:

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

Treatment:

Behavioral: EORTC QLQ-C30

Behavioral: Satisfaction questionnaire - general practitioner or home nurse

Behavioral: EORTC QLQ-LC13

Behavioral: Satisfaction questionnaire - patient