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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 (EVIDEC)

Primary Purpose

Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
EORTC QLQ-C30
Satisfaction questionnaire - patient
Satisfaction questionnaire - general practitioner or home nurse
EORTC QLQ-LC13
Sponsored by
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lung Cancer focused on measuring coordinating nurse of thoracic oncology, quality of care in thoracic oncology, lung cancer quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • GHRMSA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Coordinating nurse added to the personalized care program

Personalized care program as routine practice

Arm 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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Analysis of the feedback from healthcare professionals outside the thoracic oncology ward
Measured by satisfaction questionnaires submitted to general practitioner or home nurse
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
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
Analysis of the feedback from the patient
Measured by satisfaction questionnaires submitted to the patient

Full Information

First Posted
June 24, 2016
Last Updated
August 20, 2019
Sponsor
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
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1. Study Identification

Unique Protocol Identification Number
NCT02822209
Brief Title
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
Acronym
EVIDEC
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
May 11, 2016 (Actual)
Primary Completion Date
December 8, 2017 (Actual)
Study Completion Date
December 8, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
coordinating nurse of thoracic oncology, quality of care in thoracic oncology, lung cancer quality of life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Coordinating nurse added to the personalized care program
Arm Type
Experimental
Arm 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
Arm Title
Personalized care program as routine practice
Arm Type
Active Comparator
Arm 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
Intervention Type
Behavioral
Intervention Name(s)
EORTC QLQ-C30
Other Intervention Name(s)
The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Satisfaction questionnaire - patient
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Satisfaction questionnaire - general practitioner or home nurse
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
EORTC QLQ-LC13
Other Intervention Name(s)
The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer
Intervention Description
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
Primary Outcome Measure Information:
Title
Impact of the coordinating nurse on quality of care measured by the variation of timelines in personalized care
Description
Variation of the time between the first appointment with the thoracic oncologist and the first day of anticancer therapy
Time Frame
At visit 1, around 1 month after the beginning of the study
Secondary Outcome Measure Information:
Title
Analysis of the feedback from healthcare professionals outside the thoracic oncology ward
Description
Measured by satisfaction questionnaires submitted to general practitioner or home nurse
Time Frame
6 months after the beginning of the study
Title
Impact of a coordinating nurse in a personalized care program on the patient's quality of life
Description
Evolution of the scoring results of the EORTC QLQ-C30
Time Frame
At the beginning of the study, then around 3, around 6 and around 12 months later
Title
Impact of a coordinating nurse in a personalized care program on the patient's quality of life
Description
Evolution of the scoring results of the EORTC QLQ-LC13
Time Frame
At study enrollment, then around 3 and around 6 and around 12 months later
Title
Analysis of the feedback from the patient
Description
Measured by satisfaction questionnaires submitted to the patient
Time Frame
Around 3 and around 6 and around 12 months after beginning of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
GHRMSA
City
Mulhouse
ZIP/Postal Code
68100
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25433584
Citation
Martin F, Piquet J, Orlando JP, Blanchon F, Lebas FX. [Clinical research in pneumology in French general hospitals]. Rev Mal Respir. 2014 Nov;31(9):801-3. doi: 10.1016/j.rmr.2014.10.726. Epub 2014 Nov 5. No abstract available. French.
Results Reference
background
PubMed Identifier
23541463
Citation
Locher C, Debieuvre D, Coetmeur D, Goupil F, Molinier O, Collon T, Dayen C, Le Treut J, Asselain B, Martin F, Blanchon F, Grivaux M. Major changes in lung cancer over the last ten years in France: the KBP-CPHG studies. Lung Cancer. 2013 Jul;81(1):32-8. doi: 10.1016/j.lungcan.2013.03.001. Epub 2013 Mar 29.
Results Reference
background
PubMed Identifier
21167448
Citation
Grivaux M, Locher C, Bombaron P, Collon T, Coetmeur D, Dayen C, Debieuvre D, Goupil F, Le Treut J, Martin F, Molinier O, Asselain B, Zureik M, Blanchon F. [Study KBP-2010-CPHG: inclusion of new cases of primary lung cancer diagnosed in general hospital pneumology departments between 1st January and 31 December 2010]. Rev Pneumol Clin. 2010 Dec;66(6):375-82. doi: 10.1016/j.pneumo.2010.08.001. Epub 2010 Dec 3. French.
Results Reference
background
PubMed Identifier
24680111
Citation
Leveque N, Brouchet L, Lepage B, Hermant C, Bigay-Game L, Plat G, Dahan M, Riviere D, Didier A, Mazieres J. [An analysis of treatment delays of thoracic cancers: a prospective study]. Rev Mal Respir. 2014 Mar;31(3):208-13. doi: 10.1016/j.rmr.2013.10.001. Epub 2013 Oct 28. French.
Results Reference
background
PubMed Identifier
17762336
Citation
Goldstraw P, Crowley J, Chansky K, Giroux DJ, Groome PA, Rami-Porta R, Postmus PE, Rusch V, Sobin L; International Association for the Study of Lung Cancer International Staging Committee; Participating Institutions. The IASLC Lung Cancer Staging Project: proposals for the revision of the TNM stage groupings in the forthcoming (seventh) edition of the TNM Classification of malignant tumours. J Thorac Oncol. 2007 Aug;2(8):706-14. doi: 10.1097/JTO.0b013e31812f3c1a. Erratum In: J Thorac Oncol. 2007 Oct;2(10):985.
Results Reference
background

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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

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