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- Essai clinique NCT03302767
CAP'Onco : Psychological and Social Consultation of Professional Accompaniment in Oncology (CAP'ONCO)
This patient support system is designed to help patients regain their professional activity after their treatment. It's a 3-Axis neuropsycho-social synergy on 3 axes:
- A weekly pluridisciplinary consultation in tandem (Social worker + Psychologist / Neuropsychologist)
- Monthly information meetings and workshops (TIC'Onco reunions: collective information times and Cogit'Onco workshops: cognitive workshops
- An information booklet "Prepare the work return" The aim of this research is to evaluate efficiency in term of quality of life improvement linked to work status, utility, feasibility and patients' satisfaction.
The aim of this research is to evaluate efficiency in term of quality of life improvement linked to work status, utility, feasibility and patients' satisfaction.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Unmet need characterize in 4 points:
- Cancer and survival: challenges for cancer patients who want to work while being treated
- Cancer and career: Job instability for cancer patients
- Difficulties and isolation of patients due to a lack of coordination between healthcare professionals and colleagues/management
- Post-treatment cognitive troubles stress and hindered patient return to employment: chemo brain This research-action will propose and evaluate a concrete device: To maintain a professional activity with the support of CAP'Onco during treatment, to balance between quality of life, managing the "cancer event" and the psychosocial consequences for professional experience, to provide an early, durable and multimodal support to improve work keeping and anticipate return to employment
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Bordeaux, France, 33076
- Institut Bergonie
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Patients attending the Institut Bergonié
- Informed Consent signed.
- Patients affiliated to a French social
- living in Gironde
- Professional activity at the time of diagnosis
- Treated for - breast cancer, Hodgkin's or non-Hodgkin's lymphoma (non-cerebral), testicular cancer
- CURATIVE support
- At any time during treatment (chemotherapy or radiotherapy, or immunotherapy)
Exclusion Criteria:
- Patient deprived of liberty or subject to a legal protection measure
- History of cancers
- Cerebral pathology and / or brain metastasis
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Psychological and Social Consultation
|
Psychological and Social Consultation at Baseline, during the study and at the end of follow-up
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Quality of Life : EORTC QLQ-C30 Scores
Délai: At baseline and 5 months
|
Standardised QLQ-C30 scoring according to EORTC scoring manual (Fayers et al. EORTC QLQ-C30 scoring manual. 2001). 15 dimensions are presented below. Each dimension is a standardised score ranges from 0 to 100. A low score corresponds to a low functional level, an absence of symptoms or a low level of QoL/ overall health and, conversely, so that a high score corresponds to a high functional level, a high presence of symptoms or a high level of QoL/overall health. |
At baseline and 5 months
|
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Cognitive Complaints : FACT Cog Scale Scores
Délai: At baseline and 5 months
|
Cognitive complaints were evaluated by using the french Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) scale version 3 Assessed using median total score (range 0-132) and median scores of these 4 dimensions :
|
At baseline and 5 months
|
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Professional Recovery Scale Scores
Délai: At baseline and 5 months
|
Professional recovery was evaluated by using the Scale of motivation to Professional recovery. This scale was constructed for the needs of this exploratory research and has for vocation a later validation. It includes 62 questions and was assessed using median scores of these 7 dimensions :
|
At baseline and 5 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Tiredness : Piper MFI-20 Scale Scores
Délai: At baseline and 5 months
|
Tiredness was evaluated by using the Piper Multidimensional Fatigue Inventory (MFI-20) revised scale Assessed using median total score (range 0-10) and median scores of these 4 tiredness dimensions :
|
At baseline and 5 months
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Anxio-depressive Troubles : HAD Scale Scores
Délai: At baseline and 5 months
|
Anxio-depressive troubles were evaluated by using the Hospital Anxiety and Depression (HAD) scale. Assessed using median scores of these 2 dimensions :
|
At baseline and 5 months
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Véronique GERAT-MULLER, PhD, Institut Bergonié - Supportive Oncology Care
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IB2017-03
- 2017-A01251-52 (Autre identifiant: ANSM)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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