Precarious Elderly Patient Supported For Cancer Impact on Quality Of Life of a Domotic And Remote Assistance Approach for Elderly Patients Supported For Locally Advanced or Metastatic Cancer, Socially Isolated (PREDOMOS)
Precarious Elderly Patient Supported For Cancer Impact on Quality Of Life of a Domotic And Remote Assistance Approach for Elderly Patients Supported For Locally Advanced or Metastatic Cancer, Socially Isolated: Randomized, Comparative, Prospective Multi-Centre Study
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
In France, social isolation and prevalence of cancer increases with the population ageing: it is estimated that in 2050, 1 of 2 cancers will be diagnosed in patients over than 75 years old. Meanwhile, the share of isolated elderly increased from 16 to 24% between 2010 and 2013. It is shown that socially precarious elderly have an increased risk of dying from cancer.
Among the areas of Comprehensive Geriatric Assessment (CGA), social assessment is crucial. It can be assessed by a self-administered 8 items questionnaire, derived from MOS-SS (Medical Outcomes Study Social Support Survey) and validated in the elderly supported for cancer: m-MOS-SS (modified Medical Outcomes Study Social Support).
Once spotted, social isolation can be averted by appropriate measures, provided the intervention of a multidisciplinary team. In this area, the techniques of automation and remote assistance might have an interest. They already demonstrated their impact on falls prevention, addiction, feelings of social isolation and quality of life. However, little is known about the impact of social isolation in elderly patients supported for cancer.
The objective of the PREDOMOS study is to evaluate the impact of establishing a Program of geriatric and Social intervention associated techniques of Domotic and Remote assistance (PS-DR) on the improvement of quality of life of elderly patients, isolated or at risk of isolation, treated for locally advanced or metastatic cancer.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Marseille, Francia, 13005
- Reclutamiento
- Assistance Publique Hopitaux de Marseille
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Contacto:
- Aurélie DAUMAS, Dr
- Número de teléfono: +33 04 91 38 87 19
- Correo electrónico: aurelie.daumas@ap-hm.fr
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Contacto:
- Anne-Laure COUDERC
- Número de teléfono: +33 04 91 34 45 30
- Correo electrónico: anne-laure.couderc@ap-hm.fr
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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:
- Age ≥ 70 years
- G8 score ≤ 14.
- WHO score ≤2
- Having an ADL score ≥ 4 (Katz scale).
- Having an MMSE score > 24
- At risk of social isolation: m-MOS below 80%, and / or the following criteria: patient living alone without close help (<50 km) and / or primary caregiver of the patient's spouse, spouse limited autonomy and / or reached itself a disease (neurodegenerative disease, cancer disease, other) requiring regular hospital treatment for at least 3 months.
- Locally advanced or metastatic cancer or malignant blood disease (except acute leukemia)
- Treated by chemotherapy, new generation hormone therapy, immunotherapy or targeted therapy in first or second line of treatment, with or without radiotherapy
- Life expectancy more than 6 months
- Informed consent signed.
- Patients affiliated to French social security system in accordance with the French law on biomedical research (Article 1121-11 of the French Code of Public Health)
Exclusion Criteria:
- Patients with other cancers
- Patients should be directed immediately into a rehabilitation and recuperative care service to receive treatment or in a palliative care service
- Inability to sign a consent or under guardianship
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Interventional arm PS-DR
The interventional arm (PS-DR) will include the implementation of social aids, a monthly social monitoring and home improvement with domotic techniques and remote assistance (in connection with a call center 24h/24).
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Implementation of social aids, a monthly social monitoring and home improvement with domotic techniques and remote assistance
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Sin intervención: Reference Arm
In the reference arm, patients will have a conventional oncological care, social support measures will be left to the discretion of the clinician and the paramedical team.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Measure of the quality of life by EORTC-QLQc30 scale 3 months after treatment start
Periodo de tiempo: 3 months
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The "global health" score will constitute the main judgment criteria
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3 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Time to failure of first line of treatment
Periodo de tiempo: From date of inclusion until treatment failure, up to 6 months
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Time between inclusion and treatment failure, whatever the cause
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From date of inclusion until treatment failure, up to 6 months
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First line of treatment toxicity at the end
Periodo de tiempo: 12 months
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Measured by Toxicity scale NCI-CTCAE (National Cancer Institute - Common Terminology Criteria for Adverse Events, version 4.0).
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12 months
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Assessment of the number of chemotherapies received by patient compared to the number of prescribed chemotherapies
Periodo de tiempo: 12 months
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Treatment compliance
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12 months
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Assessment of the patient dependency level determined by evaluating the Daily living activities (ADL) with the Katz scale
Periodo de tiempo: 3 months and 6 months
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3 months and 6 months
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Assessment of the patient dependency level determined by evaluating the- instrumental activities across Lawton scale
Periodo de tiempo: 3 months and 6 months
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3 months and 6 months
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Nutritional assessment at 3 months and 6 months
Periodo de tiempo: 3 months and 6 months
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Body mass index (BMI) is the ratio of weight to height in cm squared.
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3 months and 6 months
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Functional assessment at 3 months and 6 months
Periodo de tiempo: 3 months and 6 months
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The unipodal station is to stand on one foot without aid.
A unipodal station less than 5 seconds indicating a high risk of falls (46).
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3 months and 6 months
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Overall Survival defined as the time between chemotherapy start and death
Periodo de tiempo: up to 12 months
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will be assessed at 6 months and 1 year
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up to 12 months
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Progression free Survival defined as the time between treatment start and the date of first documented progression or death, whatever the cause.
Periodo de tiempo: up to 12 months
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Time to progression is the time elapsed between the date of treatment start and the occurrence of progression or relapse if a response was observed (response or stabilization). A patient who has not progressed or who did not die at the limit of 1 year will have its censored survival time when tumor enough last evaluation conducted by the deadline of 1 year . The progress will then be defined according to the criteria RECIST1.1 . In case of death , it will be identified if it is related to tumor progression , toxicity or complication of treatment or another cause (non-specific death). |
up to 12 months
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Social isolation
Periodo de tiempo: 12 months
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Social isolation will be measured by the m -MOS questionnaire.
A result < 80% is recognized as the consensus inferior value below which patients are socially isolated position
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12 months
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Measure of the "global health score" to assess the quality of life at first line of treatment
Periodo de tiempo: 3 months and 6 months
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3 months and 6 months
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Couderc AL, Nouguerede E, Baumstarck K, Loubiere S, Le Caer H, Guillem O, Rousseau F, Greillier L, Norguet-Monnereau E, Cecile M, Boulahssass R, Le Caer F, Tournier S, Butaud C, Guillet P, Nahon S, Kirscher S, Diaz N, Morando C, Villani P, Auquier P, Daumas A. PREDOMOS study, impact of a social intervention program for socially isolated elderly cancer patients: update to the study protocol for a randomized controlled trial. Trials. 2019 Jan 15;20(1):54. doi: 10.1186/s13063-018-3127-0.
- Cretel-Durand E, Nouguerede E, Le Caer H, Rousseau F, Retornaz F, Guillem O, Couderc AL, Greillier L, Norguet E, Cecile M, Boulahssass R, Le Caer F, Tournier S, Butaud C, Guillet P, Nahon S, Poudens L, Kirscher S, Loubiere S, Diaz N, Dhorne J, Auquier P, Baumstarck K. PREDOMOS study, impact of a social intervention program for socially isolated elderly cancer patients: study protocol for a randomized controlled trial. Trials. 2017 Apr 12;18(1):174. doi: 10.1186/s13063-017-1894-7.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
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
- 2015-44
- 2015-A01976-43 (Otro identificador: ANSM)
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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