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

Sponsor

UNICANCER (Other)

Overall Status

Completed

CT.gov ID

NCT03320161

Collaborator

Ligue contre le cancer, France (Other), French National Platform Quality of Life and Cancer (Other), Association Francophone des Soins Oncologiques de Support (Other)

604

Enrollment

Locations

31.5

Actual Duration (Months)

10.4

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer Patients

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:

assess through national consensus the patients' expectations in terms of supportive care in order to help both clinicians and health care services;
prioritize them and to arrange resources according to priority needs identified;
identify supportive care for which no previous research (evidence-based medicine) has demonstrated their usefulness. A randomized clinical trial will thus be proposed;
Involve patients in the written, conduct and analyses, as well as communications of the randomized clinical trial.

Study Design

Study Type:

Observational

Actual Enrollment :

604 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 10, 2018

Actual Primary Completion Date :

Oct 10, 2019

Actual Study Completion Date :

May 26, 2021

Outcome Measures

Primary Outcome Measures

Supportive care listed and prioritized by patients [At inclusion visit]
Expectations and needs of the patients: completion of questionnaire N°1
Supportive care listed and prioritized by patients [4 to 7 months after inclusion]
Prioritize supportive care therapies: completion of questionnaire N°2 Expectations and needs of the patients questionnaire n°2 completed

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Ligue Nationale Contre le Cancer - Comité de la Somme	Amiens	France	80000
2	ICO - Site Paul Papin	Angers	France	49055
3	Ligue Nationale Contre le Cancer - Comité du Maine-et-Loire	Angers	France	49100
4	Ligue Nationale Contre le Cancer - Comité de Charente	Angoulême	France	16000
5	Ligue Nationale Contre le Cancer - Comité du Val d'Oise	Argenteuil	France	95100
6	Ligue Nationale Contre le Cancer - Comité des Pyrénées Atlantiques	Bayonne	France	64100
7	Ligue Nationale Contre le Cancer - Comité de l'Oise	Beauvais	France	60009
8	Institut Bergonié	Bordeaux	France	33076
9	Ligue Nationale Contre le Cancer - Comité du Finistère	Brest	France	29200
10	Ligue Nationale Contre le Cancer - Comité de l'Essonne	Briis-sous-Forges	France	91640
11	Ligue Nationale Contre le Cancer - Comité du Lot	Cahors	France	46000
12	Ligue Nationale Contre le Cancer - Comité du Puy-de-Dôme	Chamalières	France	63400
13	Pôle Santé Léonard de Vinci	Chambray Les Tours	France	37170
14	Centre Jean Perrin	Clermont-Ferrand	France	63011
15	Ligue Nationale Contre le Cancer - Comité du Val-de-Marne	Créteil	France	94000
16	Ligue Nationale Contre le Cancer - Comité des Landes	Dax	France	40100
17	Ligue Nationale Contre le Cancer - Comité des Alpes de Haute-Provence	Digne Les Bains	France	04995
18	Ligue Nationale Contre le Cancer - Comité de la Côte-d'Or	Dijon	France	21007
19	Centre Georges François Leclerc	Dijon	France	21079
20	Ligue Nationale Contre le Cancer - Comité des Vosges	Epinal	France	88000
21	Hôpital du Bocage	Grenoble	France	38028
22	Ligue Nationale Contre le Cancer - Comité de la Vendée	La Roche-sur-Yon	France	85925
23	Ligue Nationale Contre le Cancer - Comité de Seine-Saint-Deniss	Le Bourget	France	93351
24	Ligue Nationale Contre le Cancer - Comité de la Haute-Vienne	Limoges	France	87000
25	Ligue Nationale Contre le Cancer - Comité du Rhône	Lyon	France	69006
26	Centre Léon Bérard	Lyon	France	69373
27	Institut Paoli Calmettes	Marseille	France	13273
28	Ligue Nationale Contre le Cancer - Comité de Moselle	Metz	France	57000
29	CHRU Montpellier - Hôpital Saint Eloi	Montpellier	France	34295
30	Ligue Nationale Contre le Cancer - Comité de l'Hérault	Montpellier	France	34298
31	Hôpital Emile Muller	Mulhouse	France	68070
32	CHU de Nantes - Hôpital Dieu	Nantes	France	44093
33	Hôpital Privé du Confluent	Nantes	France	44902
34	Centre Antoine Lacassagne	Nice	France	06189
35	Ligue Nationale Contre le Cancer - Comité du Gard	Nîmes	France	300023
36	ERI Territorial du Gard - Institut de Cancérologie du Gard	Nîmes	France	30900
37	Ligue Nationale Contre le Cancer - Comité de Paris	Paris	France	75013
38	Institut Curie	Paris	France	75248
39	Ligue Nationale Contre le Cancer - Comité des Pyrénées Atlantiques	Pau	France	64000
40	Pôle Régional de Cancérologie - CHU Poitiers	Poitiers	France	86000
41	Ligue Nationale Contre le Cancer - Comité de l'Ardèche	Privas	France	07000
42	Ligue Nationale Contre le Cancer - Comité de la Marne	Reims	France	51100
43	Centre Eugène Marquis	Rennes	France	35042
44	Centre Henri Becquerel	Rouen	France	76000
45	Ligue Nationale Contre le Cancer - Comité de Seine-Maritime	Rouen	France	76005
46	Ligue Nationale Contre le Cancer - Comité des Côtes-d'Armor	Saint Brieuc	France	22023
47	Institut de Cancérologie de l'Ouest - ICO - René Gauducheau	Saint-Herblain	France	44805
48	Institut de Cancérologie de la Loire - Lucien Neuwirth	Saint-Priest-en-Jarez	France	42271
49	Ligue Nationale Contre le Cancer - Comité de la Loire	Saint-Étienne	France	42001
50	Centre Paul Strauss	Strasbourg	France	67065
51	Ligue Nationale Contre le Cancer - Comité des Hautes-Pyrénées	Tarbes	France	65000
52	Polyclinique de l'Ormeau	Tarbes	France	65000
53	Ligue Nationale Contre le Cancer - Comité de l'Aube	Troyes	France	10000
54	Institut de Cancérologie de Lorraine	Vandœuvre-lès-Nancy	France	54519
55	Ligue Nationale Contre le Cancer - Comité des Yvelines	Versailles	France	78000
56	Institut Gustave Roussy	Villejuif	France	94805
57	Ligue Nationale Contre le Cancer - Comité de la martinique	Fort de France	Martinique	97244
58	Centre Hospitalier Universitaire de Martinique	Fort de France	Martinique	97261