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
2 other identifiers
interventional
59
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable lung-cancer
Started May 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 11, 2016
CompletedFirst Submitted
Initial submission to the registry
June 24, 2016
CompletedFirst Posted
Study publicly available on registry
July 4, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 8, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 8, 2017
CompletedAugust 21, 2019
May 1, 2018
1.6 years
June 24, 2016
August 20, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Analysis of the feedback from healthcare professionals outside the thoracic oncology ward
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
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
At study enrollment, then around 3 and around 6 and around 12 months later
Analysis of the feedback from the patient
Around 3 and around 6 and around 12 months after beginning of study
Study Arms (2)
Coordinating nurse added to the personalized care program
EXPERIMENTALThe 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
Personalized care program as routine practice
ACTIVE COMPARATORA 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
Interventions
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
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.
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.
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Secondary cancer in lung
- Relapse of primary cancer in lung of the same histological type
- Previous enrollment in this study
- Uncontrolled psychological problem
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
GHRMSA
Mulhouse, 68100, France
Related Publications (5)
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.
PMID: 25433584BACKGROUNDLocher 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.
PMID: 23541463BACKGROUNDGrivaux 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.
PMID: 21167448BACKGROUNDLeveque 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.
PMID: 24680111BACKGROUNDGoldstraw 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.
PMID: 17762336BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2016
First Posted
July 4, 2016
Study Start
May 11, 2016
Primary Completion
December 8, 2017
Study Completion
December 8, 2017
Last Updated
August 21, 2019
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will not share