- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02328560
Impact of the Paramedic Announced Consultation on the Use of Patient Care With Cancer and Treated With Chemotherapy (ANNONCEP)
The project aims primarily to measure the expected paramedic consultation announcement benefits for the patient, at different levels. It will measure improvements in the management of patients treated with chemotherapy. Indeed, paramedical consultation ad aims to provide a better understanding of the disease and treatment incurred, which should lead to the implementation of joint strategies between the healthcare team and the patient to prevent the effects of and treatment of the disease by the patient and caregivers.
This improvement is to promote the fair treatment by reducing patient anxiety and / or carers and involving them in the management of their disease. In this context, it is shown a profit of paramedical consultation for the patient, it will work, based on the recommendations of the Cancer Plan, strengthen the need to routinely offer paramedic Ad consultation.
This work should also help measure the impact of ad paramedical consultation on optimizing care consumption off-line therapy and to assess the associated costs.
For patients who received paramedic ad or not consultation, it will therefore be of particular compare intercurrent hospitalizations, commuting structure of care, the number of consultations with the doctor, the reports of cure, additional biological monitoring or other health care consumption.
With the participation of several centers in the fight against cancer, this study will provide valuable information on the practice of paramedical consultation ad in several tumor sites.
It will objectify the benefit provided by the Medical device announcement for both patients and the organization and use of care prerequisite to encourage better integration of this device in the course of patient care, the consultation paramedical ad remaining poorly understood by many health professionals.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Caen, France, 14076
- Centre François Baclesse
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- 18 ≤ age <75 years;
- WHO ≤ 1;
- Patients with cancer and candidate for chemotherapy treatment of first intention;
- Solid or lymphoid malignant disease pathology for which chemotherapy is given intravenously;
- Patient affiliated to a social security scheme;
- Mastery of the French language;
- Informed Consent and signed;
- In the first cohort, patients will have received paramedical consultation announcement in the days preceding the first cycle of chemotherapy;
- In the second cohort, patients have not received paramedical consultation announcement.
Exclusion Criteria:
- Patient deprived of liberty, under guardianship;
- Any medical or psychological condition associated that could compromise the patient's ability to participate in the study;
- Exclusive Oral Chemotherapy;
- Exclusive Targeted therapy;
- Targeted therapy to be introduced during chemotherapy;
- Presence of cerebral localization;
- Pain requiring analgesics bearing 3;
- Patient in medical and social structure;
- Inability to submit to medical monitoring test for geographical, social or psychological reasons;
- Rare Cancers making matching difficult (sarcomas of soft tissue and internal organs, malignant neuroendocrine tumors sporadic and hereditary rare ...)
- Inclusion in another clinical trial.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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Paramedical ad consultation
Monitoring will be the same in the 2 groups; That paramedical consultation announcement is made in current practice.
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No paramedical ad consultation
Monitoring will be the same in the 2 groups
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Care consumption
Délai: Up to 18 weeks
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Compare among patients candidates for chemotherapy treatment IV first line, the proportions of patients who need more care than anticipated during the first cycle of chemotherapy among patients who have had paramedical announcement of consultation and those who have not had.
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Up to 18 weeks
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Hospital costs
Délai: Up to 18 weeks
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Evaluate and compare between the 2 groups the total hospital costs
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Up to 18 weeks
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Number of patients with adverse events
Délai: Up to 18 weeks
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Evaluate and compare between the 2 groups the health care consumption and side effects of chemotherapy
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Up to 18 weeks
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Satisfaction measured by self-administered questionnaires
Délai: Up to 18 weeks
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Evaluate and compare between the 2 groups patient and physicians satisfaction
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Up to 18 weeks
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Anxiety and depression measured by HADS scale
Délai: Inclusion
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Compare baseline characteristics of the 2 groups (anxiety and depression)
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Inclusion
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: François GERNIER, health executive, Centre François Baclesse
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- ANNONCEP
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