Cancer PatientsCyPRESNCT03320161
A Patient Consensus for the Research in Supportive Care in French Cancer Care Centers: the CyPRES Project
An observational study of Cancer Patients, run by UNICANCER at 58 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Patients
- How many people
- 604 participants
- Where
- 58 sitesin 2 countries
- Study dates
- 10 Oct 2018to 26 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients of french cancer care centers (ERI, Espaces Ligue) or patients Associations will be asked to answer the two questionnaires
Who may be able to join
- patients supported for cancer
- patients of ERI, Espaces Ligue (french cancer care centers) or patient associations
- patients aged at least 18 years old
Who cannot join
- Not applicable
Trial locations and contacts
58 sites in 2 countries.
58 sites in 2 countries
France56 sites
Ligue Nationale Contre le Cancer - Comité de la Somme
Amiens, 80000
ICO - Site Paul Papin
Angers, 49055
Ligue Nationale Contre le Cancer - Comité du Maine-et-Loire
Angers, 49100
Ligue Nationale Contre le Cancer - Comité de Charente
Angoulême, 16000
Ligue Nationale Contre le Cancer - Comité du Val d'Oise
Argenteuil, 95100
Ligue Nationale Contre le Cancer - Comité des Pyrénées Atlantiques
Bayonne, 64100
Ligue Nationale Contre le Cancer - Comité de l'Oise
Beauvais, 60009
Institut Bergonié
Bordeaux, 33076
Ligue Nationale Contre le Cancer - Comité du Finistère
Brest, 29200
Ligue Nationale Contre le Cancer - Comité de l'Essonne
Briis-sous-Forges, 91640
Ligue Nationale Contre le Cancer - Comité du Lot
Cahors, 46000
Ligue Nationale Contre le Cancer - Comité du Puy-de-Dôme
Chamalières, 63400
Pôle Santé Léonard de Vinci
Chambray-lès-Tours, 37170
Centre Jean Perrin
Clermont-Ferrand, 63011
Ligue Nationale Contre le Cancer - Comité du Val-de-Marne
Créteil, 94000
Ligue Nationale Contre le Cancer - Comité des Landes
Dax, 40100
Ligue Nationale Contre le Cancer - Comité des Alpes de Haute-Provence
Digne-les-Bains, 04995
Ligue Nationale Contre le Cancer - Comité de la Côte-d'Or
Dijon, 21007
Centre Georges François Leclerc
Dijon, 21079
Ligue Nationale Contre le Cancer - Comité des Vosges
Épinal, 88000
Hôpital du Bocage
Grenoble, 38028
Ligue Nationale Contre le Cancer - Comité de la Vendée
La Roche-sur-Yon, 85925
Ligue Nationale Contre le Cancer - Comité de Seine-Saint-Deniss
Le Bourget, 93351
Ligue Nationale Contre le Cancer - Comité de la Haute-Vienne
Limoges, 87000
Ligue Nationale Contre le Cancer - Comité du Rhône
Lyon, 69006
Centre Léon Bérard
Lyon, 69373
Institut Paoli Calmettes
Marseille, 13273
Ligue Nationale Contre le Cancer - Comité de Moselle
Metz, 57000
CHRU Montpellier - Hôpital Saint Eloi
Montpellier, 34295
Ligue Nationale Contre le Cancer - Comité de l'Hérault
Montpellier, 34298
Hôpital Emile Muller
Mulhouse, 68070
CHU de Nantes - Hôpital Dieu
Nantes, 44093
Hôpital Privé du Confluent
Nantes, 44902
Centre Antoine Lacassagne
Nice, 06189
Ligue Nationale Contre le Cancer - Comité du Gard
Nîmes, 300023
ERI Territorial du Gard - Institut de Cancérologie du Gard
Nîmes, 30900
Ligue Nationale Contre le Cancer - Comité de Paris
Paris, 75013
Institut Curie
Paris, 75248
Ligue Nationale Contre le Cancer - Comité des Pyrénées Atlantiques
Pau, 64000
Pôle Régional de Cancérologie - CHU Poitiers
Poitiers, 86000
Ligue Nationale Contre le Cancer - Comité de l'Ardèche
Privas, 07000
Ligue Nationale Contre le Cancer - Comité de la Marne
Reims, 51100
Centre Eugène Marquis
Rennes, 35042
Centre Henri Becquerel
Rouen, 76000
Ligue Nationale Contre le Cancer - Comité de Seine-Maritime
Rouen, 76005
Ligue Nationale Contre le Cancer - Comité des Côtes-d'Armor
Saint-Brieuc, 22023
Ligue Nationale Contre le Cancer - Comité de la Loire
Saint-Etienne, 42001
Institut de Cancérologie de l'Ouest - ICO - René Gauducheau
Saint-Herblain, 44805
Institut de Cancérologie de la Loire - Lucien Neuwirth
Saint-Priest-en-Jarez, 42271
Centre Paul Strauss
Strasbourg, 67065
Ligue Nationale Contre le Cancer - Comité des Hautes-Pyrénées
Tarbes, 65000
Polyclinique de l'Ormeau
Tarbes, 65000
Ligue Nationale Contre le Cancer - Comité de l'Aube
Troyes, 10000
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, 54519
Ligue Nationale Contre le Cancer - Comité des Yvelines
Versailles, 78000
Institut Gustave Roussy
Villejuif, 94805
Martinique2 sites
Ligue Nationale Contre le Cancer - Comité de la martinique
Fort-de-France, 97244
Centre Hospitalier Universitaire de Martinique
Fort-de-France, 97261
About this study
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.
Read the 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.
- Conditions
- Cancer Patients
- Keywords
- Supportive care, Cancer, Health-related quality of life, Consensus, Participative approach, Patient involvement, DELPHI method
- Medical subject headings
- Neoplasms, Patient Participation
What is being measured
The primary outcome is the main question the study is designed to answer.
Supportive care listed and prioritized by patients
Expectations and needs of the patients: completion of questionnaire N°1
Measured: At inclusion visit
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
Measured: 4 to 7 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2017
- Study start10 Oct 2018
- Primary completion10 Oct 2019
- Study completion26 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 604 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNICANCER
- Sponsor type
- University, hospital or other
- Collaborators
- Ligue contre le cancer, France, French National Platform Quality of Life and Cancer, Association Francophone des Soins Oncologiques de Support
- Responsible party
- Sponsor
- Investigators
- Amélie Anota, PhD, Principal investigator, Mehodology and Quality of Life in Oncology unit, CHRU Besançon, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03320161
- Sponsor's protocol ID
- UC-0106/1707
- Acronym
- CyPRES
- Status last verified
- Nov 2021
- First submitted
- 20 Oct 2017
- Last updated
- 4 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Patient Consensus for the Research in Supportive Care in French Cancer Care Centers: the CyPRES Project
- ClinicalTrials.gov ID
- NCT03320161
- Acronym / sponsor ID
- CyPRES / UC-0106/1707
- Conditions
- Cancer Patients
- Keywords
- Supportive care, Cancer, Health-related quality of life, Consensus, Participative approach, Patient involvement, DELPHI method
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 604 participants (actual)
- Lead sponsor
- UNICANCERUniversity, hospital or other
- Collaborators
- Ligue contre le cancer, France, French National Platform Quality of Life and Cancer, Association Francophone des Soins Oncologiques de Support
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- 10 Oct 2019 (actual)
- Study completion
- 26 May 2021 (actual)
- First posted
- 25 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients of french cancer care centers (ERI, Espaces Ligue) or patients Associations will be asked to answer the two questionnaires
Key inclusion criteria (3 listed)
- patients supported for cancer
- patients of ERI, Espaces Ligue (french cancer care centers) or patient associations
- patients aged at least 18 years old
Key exclusion criteria (1 listed)
- Not applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Supportive care listed and prioritized by patients
Time frame: At inclusion visit
Expectations and needs of the patients: completion of questionnaire N°1
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2021.
- Individual participant dataSharing planned: No. Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amélie Anota, PhD principal investigator
Mehodology and Quality of Life in Oncology unit, CHRU Besançon, France
58 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer Patients, run by UNICANCER at 58 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 58 sites in France, Martinique. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Supportive care listed and prioritized by patients (time frame: At inclusion visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2021.