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)

August 20, 2019 updated by: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Mulhouse, France, 68100
        • GHRMSA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Behavioral: EORTC QLQ-C30
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
Other Names:
  • The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire
Behavioral: Satisfaction questionnaire - patient
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.
Behavioral: Satisfaction questionnaire - general practitioner or home nurse
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.
Behavioral: EORTC QLQ-LC13
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
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

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
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
Other Names:
  • The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire
Behavioral: Satisfaction questionnaire - patient
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.
Behavioral: Satisfaction questionnaire - general practitioner or home nurse
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.
Behavioral: EORTC QLQ-LC13
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
Other Names:
  • The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer

What is the study measuring?

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
Time Frame: 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
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
Time Frame: 6 months after the beginning of the study
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
Time Frame: At the beginning of the study, then around 3, around 6 and around 12 months later
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
Time Frame: At study enrollment, then around 3 and around 6 and around 12 months later
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
Time Frame: Around 3 and around 6 and around 12 months after beginning of study
Measured by satisfaction questionnaires submitted to the patient
Around 3 and around 6 and around 12 months after beginning of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 11, 2016

Primary Completion (Actual)

December 8, 2017

Study Completion (Actual)

December 8, 2017

Study Registration Dates

First Submitted

June 24, 2016

First Submitted That Met QC Criteria

June 29, 2016

First Posted (Estimate)

July 4, 2016

Study Record Updates

Last Update Posted (Actual)

August 21, 2019

Last Update Submitted That Met QC Criteria

August 20, 2019

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 804
  • 2015-A01660-49 (Other Identifier: France: Agence Nationale de Sécurité du Médicament et des produits de santé)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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