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
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Cancer Patients

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