Clinical trial NCT03320161: A Patient Consensus for the Research in Supportive Care in French Cancer Care Centers: the CyPRES Project
Official title: A Patient Consensus for the Research in Supportive Care in French Cancer Care Centers: the CyPRES Project
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer Patients
Keywords: Supportive care
Cancer
Health-related quality of life
Consensus
Participative approach
Patient involvement
DELPHI method
Lead sponsor: UNICANCER
Sponsor class: OTHER
Collaborators: name: Ligue contre le cancer, France
name: French National Platform Quality of Life and Cancer
name: Association Francophone des Soins Oncologiques de Support
First posted: 2017-10-25
Enrollment: 604
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients of french cancer care centers (ERI, Espaces Ligue) or patients Associations will be asked to answer the two questionnaires

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Supportive care listed and prioritized by patients
timeFrame: At inclusion visit
measure: Supportive care listed and prioritized by patients
timeFrame: 4 to 7 months after inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: Ligue Nationale Contre le Cancer - Comité de la Somme
city: Angers
country: France
facility: ICO - Site Paul Papin
city: Angers
country: France
facility: Ligue Nationale Contre le Cancer - Comité du Maine-et-Loire
city: Angoulême
country: France
facility: Ligue Nationale Contre le Cancer - Comité de Charente
city: Argenteuil
country: France
facility: Ligue Nationale Contre le Cancer - Comité du Val d'Oise
city: Bayonne
country: France
facility: Ligue Nationale Contre le Cancer - Comité des Pyrénées Atlantiques
city: Beauvais
country: France
facility: Ligue Nationale Contre le Cancer - Comité de l'Oise
city: Bordeaux
country: France
facility: Institut Bergonié
city: Brest
country: France
facility: Ligue Nationale Contre le Cancer - Comité du Finistère
city: Briis-sous-Forges
country: France
facility: Ligue Nationale Contre le Cancer - Comité de l'Essonne
city: Cahors
country: France
facility: Ligue Nationale Contre le Cancer - Comité du Lot
city: Chamalières
country: France
facility: Ligue Nationale Contre le Cancer - Comité du Puy-de-Dôme
city: Chambray Les Tours
country: France
facility: Pôle Santé Léonard de Vinci
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
city: Créteil
country: France
facility: Ligue Nationale Contre le Cancer - Comité du Val-de-Marne
city: Dax
country: France
facility: Ligue Nationale Contre le Cancer - Comité des Landes
city: Digne Les Bains
country: France
facility: Ligue Nationale Contre le Cancer - Comité des Alpes de Haute-Provence
city: Dijon
country: France
facility: Ligue Nationale Contre le Cancer - Comité de la Côte-d'Or
city: Dijon
country: France
facility: Centre Georges François Leclerc
city: Epinal
country: France
facility: Ligue Nationale Contre le Cancer - Comité des Vosges
city: Grenoble
country: France
facility: Hôpital du Bocage
city: La Roche-sur-Yon
country: France
facility: Ligue Nationale Contre le Cancer - Comité de la Vendée
city: Le Bourget
country: France
facility: Ligue Nationale Contre le Cancer - Comité de Seine-Saint-Deniss
city: Limoges
country: France
facility: Ligue Nationale Contre le Cancer - Comité de la Haute-Vienne
city: Lyon
country: France
facility: Ligue Nationale Contre le Cancer - Comité du Rhône
city: Lyon
country: France
facility: Centre Léon Bérard
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Metz
country: France
facility: Ligue Nationale Contre le Cancer - Comité de Moselle
city: Montpellier
country: France
facility: CHRU Montpellier - Hôpital Saint Eloi
city: Montpellier
country: France
facility: Ligue Nationale Contre le Cancer - Comité de l'Hérault
city: Mulhouse
country: France
facility: Hôpital Emile Muller
city: Nantes
country: France
facility: CHU de Nantes - Hôpital Dieu
city: Nantes
country: France
facility: Hôpital Privé du Confluent
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Nîmes
country: France
facility: Ligue Nationale Contre le Cancer - Comité du Gard
city: Nîmes
country: France
facility: ERI Territorial du Gard - Institut de Cancérologie du Gard
city: Paris
country: France
facility: Ligue Nationale Contre le Cancer - Comité de Paris
city: Paris
country: France
facility: Institut Curie
city: Pau
country: France
facility: Ligue Nationale Contre le Cancer - Comité des Pyrénées Atlantiques
city: Poitiers
country: France
facility: Pôle Régional de Cancérologie - CHU Poitiers
city: Privas
country: France
facility: Ligue Nationale Contre le Cancer - Comité de l'Ardèche
city: Reims
country: France
facility: Ligue Nationale Contre le Cancer - Comité de la Marne
city: Rennes
country: France
facility: Centre Eugène Marquis
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Rouen
country: France
facility: Ligue Nationale Contre le Cancer - Comité de Seine-Maritime
city: Saint Brieuc
country: France
facility: Ligue Nationale Contre le Cancer - Comité des Côtes-d'Armor
city: Saint-Herblain
country: France
facility: Institut de Cancérologie de l'Ouest - ICO - René Gauducheau
city: Saint-Priest-en-Jarez
country: France
facility: Institut de Cancérologie de la Loire - Lucien Neuwirth
city: Saint-Étienne
country: France
facility: Ligue Nationale Contre le Cancer - Comité de la Loire
city: Strasbourg
country: France
facility: Centre Paul Strauss
city: Tarbes
country: France
facility: Ligue Nationale Contre le Cancer - Comité des Hautes-Pyrénées
city: Tarbes
country: France
facility: Polyclinique de l'Ormeau
city: Troyes
country: France
facility: Ligue Nationale Contre le Cancer - Comité de l'Aube
city: Vandœuvre-lès-Nancy
country: France
facility: Institut de Cancérologie de Lorraine
city: Versailles
country: France
facility: Ligue Nationale Contre le Cancer - Comité des Yvelines
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Fort de France
country: Martinique
facility: Ligue Nationale Contre le Cancer - Comité de la martinique
city: Fort de France
country: Martinique
facility: Centre Hospitalier Universitaire de Martinique
Study officials:
affiliation: Mehodology and Quality of Life in Oncology unit, CHRU Besançon, France
name: Amélie Anota, PhD
role: PRINCIPAL_INVESTIGATOR
References: