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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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02822209
Acronym
EVIDEC
Enrollment
59
Registered
2016-07-04
Start date
2016-05-11
Completion date
2017-12-08
Last updated
2019-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

coordinating nurse of thoracic oncology, quality of care in thoracic oncology, lung cancer quality of life

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.

Interventions

BEHAVIORALEORTC 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

BEHAVIORALSatisfaction 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.

BEHAVIORALSatisfaction 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.

BEHAVIORALEORTC 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

Sponsors

Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Impact of the coordinating nurse on quality of care measured by the variation of timelines in personalized careAt visit 1, around 1 month after the beginning of the studyVariation of the time between the first appointment with the thoracic oncologist and the first day of anticancer therapy

Secondary

MeasureTime frameDescription
Analysis of the feedback from healthcare professionals outside the thoracic oncology ward6 months after the beginning of the studyMeasured 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 lifeAt the beginning of the study, then around 3, around 6 and around 12 months laterEvolution of the scoring results of the EORTC QLQ-C30
Analysis of the feedback from the patientAround 3 and around 6 and around 12 months after beginning of studyMeasured by satisfaction questionnaires submitted to the patient

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026