- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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-
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Bordeaux, Francia, 33076
- Institut Bergonie
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Psychological and Social Consultation
|
Psychological and Social Consultation at Baseline, during the study and at the end of follow-up
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Quality of Life : EORTC QLQ-C30 Scores
Periodo de tiempo: 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
|
Cognitive Complaints : FACT Cog Scale Scores
Periodo de tiempo: 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
Periodo de tiempo: 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 :
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At baseline and 5 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Tiredness : Piper MFI-20 Scale Scores
Periodo de tiempo: 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
Periodo de tiempo: At baseline and 5 months
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Anxio-depressive troubles were evaluated by using the Hospital Anxiety and Depression (HAD) scale. Assessed using median scores of these 2 dimensions :
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At baseline and 5 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Véronique GERAT-MULLER, PhD, Institut Bergonié - Supportive Oncology Care
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IB2017-03
- 2017-A01251-52 (Otro identificador: ANSM)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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