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Completed

NCT Number: 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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GHRMSA

Mulhouse, 68100, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire

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.

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.

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

Other names: The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer

Primary outcomes

  1. Impact of the coordinating nurse on quality of care measured by the variation of timelines in personalized care

    Time frame: At visit 1, around 1 month after the beginning of the study

    Variation of the time between the first appointment with the thoracic oncologist and the first day of anticancer therapy

Secondary outcomes

  1. Analysis of the feedback from healthcare professionals outside the thoracic oncology ward

    Time frame: 6 months after the beginning of the study

    Measured by satisfaction questionnaires submitted to general practitioner or home nurse

  2. Impact of a coordinating nurse in a personalized care program on the patient's quality of life

    Time frame: At the beginning of the study, then around 3, around 6 and around 12 months later

    Evolution of the scoring results of the EORTC QLQ-C30

  3. Impact of a coordinating nurse in a personalized care program on the patient's quality of life

    Time frame: At study enrollment, then around 3 and around 6 and around 12 months later

    Evolution of the scoring results of the EORTC QLQ-LC13

  4. Analysis of the feedback from the patient

    Time frame: Around 3 and around 6 and around 12 months after beginning of study

    Measured by satisfaction questionnaires submitted to the patient

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

Other

Registry information

Official study 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

Acronym: EVIDEC

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 4, 2016
Registry last updated
Aug 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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