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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-A01660-49 | Other Identifier | France: Agence Nationale de Sécurité du Médicament et des produits de santé |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coordinating nurse added to the personalized care program | Experimental | The coordinating nurse (CN) is dedicated to the newly diagnosed patient to optimize their personalized care program.
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| Personalized care program as routine practice | Active Comparator | 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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EORTC QLQ-C30 | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Impact of a coordinating nurse in a personalized care program on the patient's quality of life |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GHRMSA | Mulhouse | 68100 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25433584 | Background | 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. | |
| 23541463 | Background | 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. |
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| Satisfaction questionnaire - patient | Behavioral | 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. |
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| Satisfaction questionnaire - general practitioner or home nurse | Behavioral | 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. |
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| EORTC QLQ-LC13 | Behavioral | 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 |
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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 | 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 | Measured by satisfaction questionnaires submitted to the patient | Around 3 and around 6 and around 12 months after beginning of study |
| 21167448 | Background | 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. |
| 24680111 | Background | 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. |
| 17762336 | Background | 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. |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D064691 | Nurses, Community Health |
| ID | Term |
|---|---|
| D009726 | Nurses |
| D006282 | Health Personnel |
| D005159 | Health Care Facilities Workforce and Services |
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