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

Lung Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02822209
• Other study ID #: 804
• Secondary ID: 2015-A01660-49
• Status: Completed
• Phase: N/A
• Start date: May 11, 2016
• Est. completion date: December 8, 2017

Study information

• Verified date: May 2018
• Source: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: December 8, 2017
• Est. primary completion date: December 8, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

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
• 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.
• 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.
• 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

Locations

Country	Name	City	State
France	GHRMSA	Mulhouse

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

Country where clinical trial is conducted

France, 

References & Publications (5)

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. Erratum in: J Thorac Oncol. 2007 Oct;2(10):985. — View Citation

Grivaux M, Locher C, Bombaron P, Collon T, Coëtmeur 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. — View 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. — View Citation

Locher C, Debieuvre D, Coëtmeur 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. — View 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. French. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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