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

November 3, 2021 updated by: UNICANCER
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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

604

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80000
        • Ligue Nationale Contre le Cancer - Comité de la Somme
      • Angers, France, 49055
        • ICO - Site Paul Papin
      • Angers, France, 49100
        • Ligue Nationale Contre le Cancer - Comité du Maine-et-Loire
      • Angoulême, France, 16000
        • Ligue Nationale Contre le Cancer - Comité de Charente
      • Argenteuil, France, 95100
        • Ligue Nationale Contre le Cancer - Comité du Val d'Oise
      • Bayonne, France, 64100
        • Ligue Nationale Contre le Cancer - Comité des Pyrénées Atlantiques
      • Beauvais, France, 60009
        • Ligue Nationale Contre le Cancer - Comité de l'Oise
      • Bordeaux, France, 33076
        • Institut Bergonié
      • Brest, France, 29200
        • Ligue Nationale Contre le Cancer - Comité du Finistère
      • Briis-sous-Forges, France, 91640
        • Ligue Nationale Contre le Cancer - Comité de l'Essonne
      • Cahors, France, 46000
        • Ligue Nationale Contre le Cancer - Comité du Lot
      • Chamalières, France, 63400
        • Ligue Nationale Contre le Cancer - Comité du Puy-de-Dôme
      • Chambray Les Tours, France, 37170
        • Pole Sante Leonard de Vinci
      • Clermont-Ferrand, France, 63011
        • Centre Jean Perrin
      • Créteil, France, 94000
        • Ligue Nationale Contre le Cancer - Comité du Val-de-Marne
      • Dax, France, 40100
        • Ligue Nationale Contre le Cancer - Comité des Landes
      • Digne Les Bains, France, 04995
        • Ligue Nationale Contre le Cancer - Comité des Alpes de Haute-Provence
      • Dijon, France, 21079
        • Centre GEORGES FRANÇOIS LECLERC
      • Dijon, France, 21007
        • Ligue Nationale Contre le Cancer - Comité de la Côte-d'Or
      • Epinal, France, 88000
        • Ligue Nationale Contre le Cancer - Comité des Vosges
      • Grenoble, France, 38028
        • Hopital Du Bocage
      • La Roche-sur-Yon, France, 85925
        • Ligue Nationale Contre le Cancer - Comité de la Vendée
      • Le Bourget, France, 93351
        • Ligue Nationale Contre le Cancer - Comité de Seine-Saint-Deniss
      • Limoges, France, 87000
        • Ligue Nationale Contre le Cancer - Comité de la Haute-Vienne
      • Lyon, France, 69373
        • Centre Leon Berard
      • Lyon, France, 69006
        • Ligue Nationale Contre le Cancer - Comité du Rhône
      • Marseille, France, 13273
        • Institut Paoli Calmettes
      • Metz, France, 57000
        • Ligue Nationale Contre le Cancer - Comité de Moselle
      • Montpellier, France, 34295
        • CHRU Montpellier - Hopital Saint Eloi
      • Montpellier, France, 34298
        • Ligue Nationale Contre le Cancer - Comité de l'Hérault
      • Mulhouse, France, 68070
        • Hôpital Emile Muller
      • Nantes, France, 44093
        • CHU de Nantes - Hôpital Dieu
      • Nantes, France, 44902
        • Hôpital Privé du Confluent
      • Nice, France, 06189
        • Centre Antoine Lacassagne
      • Nîmes, France, 300023
        • Ligue Nationale Contre le Cancer - Comité du Gard
      • Nîmes, France, 30900
        • ERI Territorial du Gard - Institut de Cancérologie du Gard
      • Paris, France, 75248
        • Institut Curie
      • Paris, France, 75013
        • Ligue Nationale Contre le Cancer - Comité de Paris
      • Pau, France, 64000
        • Ligue Nationale Contre le Cancer - Comité des Pyrénées Atlantiques
      • Poitiers, France, 86000
        • Pôle Régional de Cancérologie - CHU Poitiers
      • Privas, France, 07000
        • Ligue Nationale Contre le Cancer - Comité de l'Ardèche
      • Reims, France, 51100
        • Ligue Nationale Contre le Cancer - Comité de la Marne
      • Rennes, France, 35042
        • Centre Eugene Marquis
      • Rouen, France, 76000
        • Centre Henri Becquerel
      • Rouen, France, 76005
        • Ligue Nationale Contre le Cancer - Comité de Seine-Maritime
      • Saint Brieuc, France, 22023
        • Ligue Nationale Contre le Cancer - Comité des Côtes-d'Armor
      • Saint-Herblain, France, 44805
        • Institut de Cancérologie de l'Ouest - ICO - René Gauducheau
      • Saint-Priest-en-Jarez, France, 42271
        • Institut de Cancérologie de la Loire - Lucien Neuwirth
      • Saint-Étienne, France, 42001
        • Ligue Nationale Contre le Cancer - Comité de la Loire
      • Strasbourg, France, 67065
        • Centre PAUL STRAUSS
      • Tarbes, France, 65000
        • Polyclinique de l'Ormeau
      • Tarbes, France, 65000
        • Ligue Nationale Contre le Cancer - Comité des Hautes-Pyrénées
      • Troyes, France, 10000
        • Ligue Nationale Contre le Cancer - Comité de l'Aube
      • Vandœuvre-lès-Nancy, France, 54519
        • Institut de Cancérologie de Lorraine
      • Versailles, France, 78000
        • Ligue Nationale Contre le Cancer - Comité des Yvelines
      • Villejuif, France, 94805
        • Institut Gustave Roussy
  • Martinique
      • Fort de France, Martinique, 97244
        • Ligue Nationale Contre le Cancer - Comité de la martinique
      • Fort de France, Martinique, 97261
        • Centre Hospitalier Universitaire de Martinique

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Supportive care listed and prioritized by patients
Time Frame: At inclusion visit
Expectations and needs of the patients: completion of questionnaire N°1
At inclusion visit
Supportive care listed and prioritized by patients
Time Frame: 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
4 to 7 months after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UNICANCER

Collaborators

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

Investigators

  • Principal Investigator: Amélie Anota, PhD, Mehodology and Quality of Life in Oncology unit, CHRU Besançon, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2018

Primary Completion (Actual)

October 10, 2019

Study Completion (Actual)

May 26, 2021

Study Registration Dates

First Submitted

October 20, 2017

First Submitted That Met QC Criteria

October 20, 2017

First Posted (Actual)

October 25, 2017

Study Record Updates

Last Update Posted (Actual)

November 4, 2021

Last Update Submitted That Met QC Criteria

November 3, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UC-0106/1707

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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