Lung CancerEVIDECNCT02822209
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 study testing EORTC QLQ-C30, Satisfaction questionnaire - patient and Satisfaction questionnaire - general practitioner or home nurse in people with Lung Cancer, run by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- EORTC QLQ-C30, Satisfaction questionnaire - patient and Satisfaction questionnaire - general practitioner or home nurse
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteFrance
- Study dates
- 11 May 2016to 8 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Secondary cancer in lung
- Relapse of primary cancer in lung of the same histological type
- Previous enrollment in this study
- Uncontrolled psychological problem
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- EORTC QLQ-C30, Satisfaction questionnaire - patient, Satisfaction questionnaire - general practitioner or home nurse, EORTC QLQ-LC13
- Keywords
- coordinating nurse of thoracic oncology, quality of care in thoracic oncology, lung cancer quality of life
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EORTC QLQ-C30Behavioural
Also called The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire
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
Satisfaction questionnaire - patientBehavioural
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 nurseBehavioural
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-LC13Behavioural
Also called The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer
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
| Study group | Role | What they receive |
|---|---|---|
| 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.
* 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 Receives: Behavioral: EORTC QLQ-C30; Behavioral: Satisfaction questionnaire - patient; Behavioral: Satisfaction questionnaire - general practitioner or home nurse; Behavioral: EORTC QLQ-LC13 |
| 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.
* 2 Satisfaction questionnaires completed :
* satisfaction questionnaire - patient,
* satisfaction questionnaire - general practitioner or home nurse Receives: Behavioral: EORTC QLQ-C30; Behavioral: Satisfaction questionnaire - patient; Behavioral: Satisfaction questionnaire - general practitioner or home nurse; Behavioral: EORTC QLQ-LC13 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured by satisfaction questionnaires submitted to general practitioner or home nurse
Measured: 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
Evolution of the scoring results of the EORTC QLQ-C30
Measured: 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
Measured: 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
Measured: Around 3 and around 6 and around 12 months after beginning of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2016 (estimated)
- Study start11 May 2016
- Primary completion8 Dec 2017
- Study completion8 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02822209
- Sponsor's protocol ID
- 804
- Other IDs
- 2015-A01660-49
- Acronym
- EVIDEC
- Status last verified
- May 2018
- First submitted
- 24 Jun 2016
- Last updated
- 21 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 25433584Locher 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.
PubMed 23541463Grivaux 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.
PubMed 21167448Leveque 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.
PubMed 24680111Goldstraw 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.
PubMed 17762336
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02822209
- Acronym / sponsor ID
- EVIDEC / 804
- Conditions
- Lung Cancer
- Keywords
- coordinating nurse of thoracic oncology, quality of care in thoracic oncology, lung cancer quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Groupe Hospitalier de la Region de Mulhouse et Sud AlsaceUniversity, hospital or other
- Study start
- 11 May 2016 (actual)
- Primary completion
- 8 Dec 2017 (actual)
- Study completion
- 8 Dec 2017 (actual)
- First posted
- 4 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coordinating nurse added to the personalized care program | Experimental | Behavioral: EORTC QLQ-C30, Behavioral: Satisfaction questionnaire - patient, Behavioral: Satisfaction questionnaire - general practitioner or home nurse, Behavioral: EORTC QLQ-LC13The 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 comparator | Behavioral: EORTC QLQ-C30, Behavioral: Satisfaction questionnaire - patient, Behavioral: Satisfaction questionnaire - general practitioner or home nurse, Behavioral: EORTC QLQ-LC13A 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Secondary cancer in lung
- Relapse of primary cancer in lung of the same histological type
- Previous enrollment in this study
- Uncontrolled psychological problem
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EORTC QLQ-C30Also: The European Organization for Research and Treatment of Cancer Quality of Life QuestionnaireQuestionnaire 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 | Behavioural | Coordinating nurse added to the personalized care program, Personalized care program as routine practice |
| Satisfaction questionnaire - patientThe 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. | Behavioural | Coordinating nurse added to the personalized care program, Personalized care program as routine practice |
| Satisfaction questionnaire - general practitioner or home nurseThe 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. | Behavioural | Coordinating nurse added to the personalized care program, Personalized care program as routine practice |
| EORTC QLQ-LC13Also: The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Lung CancerQuestionnaire 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 | Behavioural | Coordinating nurse added to the personalized care program, Personalized care program as routine practice |
Primary outcome
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
4 secondary outcomes
Analysis of the feedback from healthcare professionals outside the thoracic oncology ward
Time frame: 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
Time frame: 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
Time frame: At study enrollment, then around 3 and around 6 and around 12 months later
Analysis of the feedback from the patient
Time frame: Around 3 and around 6 and around 12 months after beginning of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2019.
- Background: PubMed 25433584Martin 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.
- Background: PubMed 23541463Locher 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.
- Background: PubMed 21167448Grivaux 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.
- Background: PubMed 24680111Leveque 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.
- Background: PubMed 17762336Goldstraw 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EORTC QLQ-C30, Satisfaction questionnaire - patient and Satisfaction questionnaire - general practitioner or home nurse in people with Lung Cancer, run by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02822209, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2019.