Clinical trial NCT02822209: 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
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
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: coordinating nurse of thoracic oncology
quality of care in thoracic oncology
lung cancer quality of life
Lead sponsor: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
Sponsor class: OTHER
First posted: 2016-07-04
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Impact of the coordinating nurse on quality of care measured by the variation of timelines in personalized care
timeFrame: At visit 1, around 1 month after the beginning of the study
Secondary outcomes:
measure: Analysis of the feedback from healthcare professionals outside the thoracic oncology ward
timeFrame: 6 months after the beginning of the study
measure: Impact of a coordinating nurse in a personalized care program on the patient's quality of life
timeFrame: At the beginning of the study, then around 3, around 6 and around 12 months later
measure: Impact of a coordinating nurse in a personalized care program on the patient's quality of life
timeFrame: At study enrollment, then around 3 and around 6 and around 12 months later
measure: Analysis of the feedback from the patient
timeFrame: Around 3 and around 6 and around 12 months after beginning of study
Other outcomes:
Locations:
city: Mulhouse
country: France
facility: GHRMSA
Study officials:
References:
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.
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.
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.
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.
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.