Study protocol of the CREDO randomised controlled trial: evaluation of a structured return home consultation for patients suffering from metastaticcancer
Introduction Patients suffering from cancer are often managed by multiple health professionals. General practitioners with specific skills in oncology could facilitate care coordination between hospital and general practice in the management of these patients. To explore this hypothesis, we run a ra...
| Main Authors: | , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2023-01-01
|
| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/1/e062219.full |
| _version_ | 1797938318659289088 |
|---|---|
| author | Cyrille Delpierre Laetitia Gimenez Jean-Pierre Delord Laurent Molinier Nadège Costa Pascale Grosclaude Marie-Eve Rougé Bugat Vladimir Druel |
| author_facet | Cyrille Delpierre Laetitia Gimenez Jean-Pierre Delord Laurent Molinier Nadège Costa Pascale Grosclaude Marie-Eve Rougé Bugat Vladimir Druel |
| author_sort | Cyrille Delpierre |
| collection | DOAJ |
| description | Introduction Patients suffering from cancer are often managed by multiple health professionals. General practitioners with specific skills in oncology could facilitate care coordination between hospital and general practice in the management of these patients. To explore this hypothesis, we run a randomised clinical trial, called ‘Concertation de REtour à DOmicile, CREDO’. The main objective is to explore the effectiveness of a ‘return home’ consultation compared with standard care. The number of unscheduled visits to care centres is used to evaluate the effectiveness of the treatment.Methods and analysis CREDO is a multicentre, randomised, open-label, prospective trial. It takes place in two specialised cancer care centres in southern France (Occitania region). Patient inclusion criteria are: be over 18 years old; be treated with a first cycle of metastatic chemotherapy in a specialised cancer care centre; have a metastatic solid cancer and be returning home after treatment. Patients are randomised in two arms: standard-arm (conventional management) or intervention-arm (CREDO management). In the intervention arm, a ‘return home’ consultation is carried out in three steps. First, the investigating GP (GP with specific skills in oncology) from the specialised care centre collects information about the patient and patient’s management choices. Then, the investigating GP conducts an interview with the patient’s referring GP to quickly communicate and discuss information about the patient. Finally, the investigating GP summarises these exchanges and transmits this information to the care centres chosen by the patient.All the patients are followed for 1 year.Statistical and medicoeconomic analysis are planned.Ethics and dissemination This clinical trial is registered under ClinicalTrials.gov identifier and was approved by the ethics committee of South-Western French Committee for the Protection of Persons (number: 2016-A01587-44) and from the French National Drug Safety Agency (ANSM, number: 2016111500034).An international publication of the final results and conference presentations will be planned.Trial registration number NCT02857400. |
| first_indexed | 2024-04-10T18:58:40Z |
| format | Article |
| id | doaj.art-56fe93a6df5f4e7a91115f9054604838 |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-04-10T18:58:40Z |
| publishDate | 2023-01-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-56fe93a6df5f4e7a91115f90546048382023-01-31T13:30:07ZengBMJ Publishing GroupBMJ Open2044-60552023-01-0113110.1136/bmjopen-2022-062219Study protocol of the CREDO randomised controlled trial: evaluation of a structured return home consultation for patients suffering from metastaticcancerCyrille Delpierre0Laetitia Gimenez1Jean-Pierre Delord2Laurent Molinier3Nadège Costa4Pascale Grosclaude5Marie-Eve Rougé Bugat6Vladimir Druel7UMR 1295 INSERM - Université Toulouse III Paul Sabatier, Toulouse, FranceDépartement Universitaire de Médecine Générale – Université Toulouse III Paul Sabatier, Toulouse, FranceInstitut Universitaire du Cancer Toulouse – Oncopole (IUCT-O), Toulouse, FranceUMR 1295 INSERM - Université Toulouse III Paul Sabatier, Toulouse, FranceUMR 1295 INSERM - Université Toulouse III Paul Sabatier, Toulouse, FranceUMR 1295 INSERM - Université Toulouse III Paul Sabatier, Toulouse, FranceDépartement Universitaire de Médecine Générale – Université Toulouse III Paul Sabatier, Toulouse, FranceDépartement Universitaire de Médecine Générale – Université Toulouse III Paul Sabatier, Toulouse, FranceIntroduction Patients suffering from cancer are often managed by multiple health professionals. General practitioners with specific skills in oncology could facilitate care coordination between hospital and general practice in the management of these patients. To explore this hypothesis, we run a randomised clinical trial, called ‘Concertation de REtour à DOmicile, CREDO’. The main objective is to explore the effectiveness of a ‘return home’ consultation compared with standard care. The number of unscheduled visits to care centres is used to evaluate the effectiveness of the treatment.Methods and analysis CREDO is a multicentre, randomised, open-label, prospective trial. It takes place in two specialised cancer care centres in southern France (Occitania region). Patient inclusion criteria are: be over 18 years old; be treated with a first cycle of metastatic chemotherapy in a specialised cancer care centre; have a metastatic solid cancer and be returning home after treatment. Patients are randomised in two arms: standard-arm (conventional management) or intervention-arm (CREDO management). In the intervention arm, a ‘return home’ consultation is carried out in three steps. First, the investigating GP (GP with specific skills in oncology) from the specialised care centre collects information about the patient and patient’s management choices. Then, the investigating GP conducts an interview with the patient’s referring GP to quickly communicate and discuss information about the patient. Finally, the investigating GP summarises these exchanges and transmits this information to the care centres chosen by the patient.All the patients are followed for 1 year.Statistical and medicoeconomic analysis are planned.Ethics and dissemination This clinical trial is registered under ClinicalTrials.gov identifier and was approved by the ethics committee of South-Western French Committee for the Protection of Persons (number: 2016-A01587-44) and from the French National Drug Safety Agency (ANSM, number: 2016111500034).An international publication of the final results and conference presentations will be planned.Trial registration number NCT02857400.https://bmjopen.bmj.com/content/13/1/e062219.full |
| spellingShingle | Cyrille Delpierre Laetitia Gimenez Jean-Pierre Delord Laurent Molinier Nadège Costa Pascale Grosclaude Marie-Eve Rougé Bugat Vladimir Druel Study protocol of the CREDO randomised controlled trial: evaluation of a structured return home consultation for patients suffering from metastaticcancer BMJ Open |
| title | Study protocol of the CREDO randomised controlled trial: evaluation of a structured return home consultation for patients suffering from metastaticcancer |
| title_full | Study protocol of the CREDO randomised controlled trial: evaluation of a structured return home consultation for patients suffering from metastaticcancer |
| title_fullStr | Study protocol of the CREDO randomised controlled trial: evaluation of a structured return home consultation for patients suffering from metastaticcancer |
| title_full_unstemmed | Study protocol of the CREDO randomised controlled trial: evaluation of a structured return home consultation for patients suffering from metastaticcancer |
| title_short | Study protocol of the CREDO randomised controlled trial: evaluation of a structured return home consultation for patients suffering from metastaticcancer |
| title_sort | study protocol of the credo randomised controlled trial evaluation of a structured return home consultation for patients suffering from metastaticcancer |
| url | https://bmjopen.bmj.com/content/13/1/e062219.full |
| work_keys_str_mv | AT cyrilledelpierre studyprotocolofthecredorandomisedcontrolledtrialevaluationofastructuredreturnhomeconsultationforpatientssufferingfrommetastaticcancer AT laetitiagimenez studyprotocolofthecredorandomisedcontrolledtrialevaluationofastructuredreturnhomeconsultationforpatientssufferingfrommetastaticcancer AT jeanpierredelord studyprotocolofthecredorandomisedcontrolledtrialevaluationofastructuredreturnhomeconsultationforpatientssufferingfrommetastaticcancer AT laurentmolinier studyprotocolofthecredorandomisedcontrolledtrialevaluationofastructuredreturnhomeconsultationforpatientssufferingfrommetastaticcancer AT nadegecosta studyprotocolofthecredorandomisedcontrolledtrialevaluationofastructuredreturnhomeconsultationforpatientssufferingfrommetastaticcancer AT pascalegrosclaude studyprotocolofthecredorandomisedcontrolledtrialevaluationofastructuredreturnhomeconsultationforpatientssufferingfrommetastaticcancer AT marieeverougebugat studyprotocolofthecredorandomisedcontrolledtrialevaluationofastructuredreturnhomeconsultationforpatientssufferingfrommetastaticcancer AT vladimirdruel studyprotocolofthecredorandomisedcontrolledtrialevaluationofastructuredreturnhomeconsultationforpatientssufferingfrommetastaticcancer |