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NCT03320161 Clinical Trial

A Patient Consensus for the Research in Supportive Care in French Cancer Care Centers: the CyPRES Project

Cancer Patients Clinical Trial

— CyPRES  

Official title:
A Patient Consensus for the Research in Supportive Care in French Cancer Care Centers: the CyPRES Project

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03320161
Other study ID # UC-0106/1707
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 10, 2018
Est. completion date May 26, 2021

Study information
Verified date November 2021
Source UNICANCER
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In oncology a number of supportive care therapies are proposed to patients. This study will identify the different therapies and prioritize these therapies from the patients' perspectives. This study will provide a framework for optimizing supportive care strategies and identifying those therapies that need to be validated by clinical trials.

Description:

In oncology, supportive care should be used along with curative treatment or palliative care in order to improve patients' health-related quality of life, overall survival and to better support treatment side effects as well as the disease evolution. Unfortunately, they are not widely used in clinical practice. A direct assessment of the needs perceived unmet by patients could allow to assess the magnitude of expectations to better target treatments as example. A prospective assessment of the expectations and needs of the patients is thus essential. This would also allow help to highlight the convergence between supportive care proposed and used and those expected by patients. The first step to understanding how to optimize the use of resources and to improve the quality of care is to identify patient's expectations. Moreover, it is now well recognized that patients should play a key role in the research and that their active participation in research can increase the relevance of the research. In this context, the CyPRES project aims to: 1. assess through national consensus the patients' expectations in terms of supportive care in order to help both clinicians and health care services; 2. prioritize them and to arrange resources according to priority needs identified; 3. identify supportive care for which no previous research (evidence-based medicine) has demonstrated their usefulness. A randomized clinical trial will thus be proposed; 4. Involve patients in the written, conduct and analyses, as well as communications of the randomized clinical trial.

Recruitment information / eligibility
Status Completed
Enrollment 604
Est. completion date May 26, 2021
Est. primary completion date October 10, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - patients supported for cancer - patients of ERI, Espaces Ligue (french cancer care centers) or patient associations - patients aged at least 18 years old Exclusion Criteria: - Not applicable

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Ligue Nationale Contre le Cancer - Comité de la Somme Amiens
France ICO - Site Paul Papin Angers
France Ligue Nationale Contre le Cancer - Comité du Maine-et-Loire Angers
France Ligue Nationale Contre le Cancer - Comité de Charente Angoulême
France Ligue Nationale Contre le Cancer - Comité du Val d'Oise Argenteuil
France Ligue Nationale Contre le Cancer - Comité des Pyrénées Atlantiques Bayonne
France Ligue Nationale Contre le Cancer - Comité de l'Oise Beauvais
France Institut Bergonié Bordeaux
France Ligue Nationale Contre le Cancer - Comité du Finistère Brest
France Ligue Nationale Contre le Cancer - Comité de l'Essonne Briis-sous-Forges
France Ligue Nationale Contre le Cancer - Comité du Lot Cahors
France Ligue Nationale Contre le Cancer - Comité du Puy-de-Dôme Chamalières
France Pôle Santé Léonard de Vinci Chambray Les Tours
France Centre Jean Perrin Clermont-Ferrand
France Ligue Nationale Contre le Cancer - Comité du Val-de-Marne Créteil
France Ligue Nationale Contre le Cancer - Comité des Landes Dax
France Ligue Nationale Contre le Cancer - Comité des Alpes de Haute-Provence Digne Les Bains
France Centre Georges François Leclerc Dijon
France Ligue Nationale Contre le Cancer - Comité de la Côte-d'Or Dijon
France Ligue Nationale Contre le Cancer - Comité des Vosges Epinal
France Hôpital du Bocage Grenoble
France Ligue Nationale Contre le Cancer - Comité de la Vendée La Roche-sur-Yon
France Ligue Nationale Contre le Cancer - Comité de Seine-Saint-Deniss Le Bourget
France Ligue Nationale Contre le Cancer - Comité de la Haute-Vienne Limoges
France Centre Léon Bérard Lyon
France Ligue Nationale Contre le Cancer - Comité du Rhône Lyon
France Institut Paoli Calmettes Marseille
France Ligue Nationale Contre le Cancer - Comité de Moselle Metz
France CHRU Montpellier - Hôpital Saint Eloi Montpellier
France Ligue Nationale Contre le Cancer - Comité de l'Hérault Montpellier
France Hôpital Emile Muller Mulhouse
France CHU de Nantes - Hôpital Dieu Nantes
France Hôpital Privé du Confluent Nantes
France Centre Antoine Lacassagne Nice
France ERI Territorial du Gard - Institut de Cancérologie du Gard Nîmes
France Ligue Nationale Contre le Cancer - Comité du Gard Nîmes
France Institut Curie Paris
France Ligue Nationale Contre le Cancer - Comité de Paris Paris
France Ligue Nationale Contre le Cancer - Comité des Pyrénées Atlantiques Pau
France Pôle Régional de Cancérologie - CHU Poitiers Poitiers
France Ligue Nationale Contre le Cancer - Comité de l'Ardèche Privas
France Ligue Nationale Contre le Cancer - Comité de la Marne Reims
France Centre Eugène Marquis Rennes
France Centre Henri Becquerel Rouen
France Ligue Nationale Contre le Cancer - Comité de Seine-Maritime Rouen
France Ligue Nationale Contre le Cancer - Comité des Côtes-d'Armor Saint Brieuc
France Ligue Nationale Contre le Cancer - Comité de la Loire Saint-Étienne
France Institut de Cancérologie de l'Ouest - ICO - René Gauducheau Saint-Herblain
France Institut de Cancérologie de la Loire - Lucien Neuwirth Saint-Priest-en-Jarez
France Centre Paul Strauss Strasbourg
France Ligue Nationale Contre le Cancer - Comité des Hautes-Pyrénées Tarbes
France Polyclinique de l'Ormeau Tarbes
France Ligue Nationale Contre le Cancer - Comité de l'Aube Troyes
France Institut de Cancérologie de Lorraine Vandœuvre-lès-Nancy
France Ligue Nationale Contre le Cancer - Comité des Yvelines Versailles
France Institut Gustave Roussy Villejuif
Martinique Centre Hospitalier Universitaire de Martinique Fort de France
Martinique Ligue Nationale Contre le Cancer - Comité de la martinique Fort de France

Sponsors (4)
Lead Sponsor Collaborator
UNICANCER Association Francophone des Soins Oncologiques de Support, French National Platform Quality of Life and Cancer, Ligue contre le cancer, France

Countries where clinical trial is conducted

France,  Martinique, 

Outcome
Type Measure Description Time frame Safety issue
Primary Supportive care listed and prioritized by patients Expectations and needs of the patients: completion of questionnaire N°1 At inclusion visit
Primary Supportive care listed and prioritized by patients Prioritize supportive care therapies: completion of questionnaire N°2 Expectations and needs of the patients questionnaire n°2 completed 4 to 7 months after inclusion
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