Evaluation of Interest of a Systematic Screening for Oncological Supportive Care Needs (DBSOS)
21 de mayo de 2019 actualizado por: Centre Paul Strauss
Evaluation of Interest of a Systematic Screening for Oncological Supportive Care
Monocentric, descriptive, cross-sectional, interventional, prospective and non-randomized study.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
The study will unfold in the followed day hospital's departments of the Paul Strauss Cancer Center (Strasbourg, France) : supportive care department, chemiotherapy department and radiotherapy department. The study is based on two questionnaires that include six sections : nutrition, social, psychologic, physiotherapy, pain and supportive care needs evaluation.
The first questionnaire gives information about the patient and allow to screen supportive care needs. It should be read by medical or paramedical staff who report the function of the reader and options that are proposed to the patient after reading the questionnaire.
The second questionnaire will be done after 4 to 6 weeks by a phone call from the clinical research nurse. The objective of this questionnaire is to determine what kind of care have been provided.
Tipo de estudio
Intervencionista
Inscripción (Actual)
134
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
-
Strasbourg, Francia, 67065
- Centre PAUL STRAUSS
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Patient treated for a cancer
- Age ≥ 18 years old
- Receiving treatment (chemotherapy and/or radiotherapy) in day hospital and/or supportive care department
- Able to speak, read and understand French
- Able to communicate by phone
- Written informed consent obtained from the patient
- Registration in a national health care system
Exclusion Criteria:
- Minor or protected adult
- Pregnant or breastfeeding woman
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿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: observation cohort
Questionnaire to assess the supportive care needs
|
Evaluation of interest of a systematic screening for oncological supportive care needs
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Evaluation of using oncological supportive cares after evaluation of supportive care needs reviewed by a professional of health, by a phone call
Periodo de tiempo: 4 to 6 weeks after baseline
|
Assess the percentage of using oncological supportive cares after evaluation of supportive care needs reviewed by a professional.
The use of supportive cares is evaluated with an hetero-questionnaire created for this study.
The hetero-questionnaire consists in a phone call to evaluate the evolution of each item of the self-assessment questionnaire (which includes 6 evaluations : a nutritional evaluation (10 items), a social evaluation (8 items), a psychologic evaluation (6 items), a physiological evaluation (7 items), a pain evaluation (4 items) and a supportive care needs evaluation (6 items)).
|
4 to 6 weeks after baseline
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Evaluation of initial supportive care needs by the self-assessment questionnaire
Periodo de tiempo: baseline
|
Assess the percentage of initial supportive care needs evaluated by the self-assessment questionnaire created for this study.
It includes evaluations : a nutritional evaluation (10 items), a social evaluation (8 items), a psychologic evaluation (6 items), a physiological evaluation (7 items), a pain evaluation (4 items) and a supportive care needs evaluation (6 items).
|
baseline
|
|
Assess the correlation between supportive care needs and age
Periodo de tiempo: This analyse will be realized at the end of the study (9 weeks after baseline)
|
Correlate the percentage of supportive care needs to age by a Pearson Chi squared test
|
This analyse will be realized at the end of the study (9 weeks after baseline)
|
|
Assess the correlation between supportive care needs and sexe
Periodo de tiempo: This analyse will be realized at the end of the study (9 weeks after baseline)
|
Correlate the percentage of supportive care needs to sexe by a Pearson Chi squared test.
|
This analyse will be realized at the end of the study (9 weeks after baseline)
|
|
Assess the correlation between supportive care needs and type of cancer
Periodo de tiempo: This analyse will be realized at the end of the study (9 weeks after baseline)
|
Correlate the percentage of supportive care needs to the type of cancer by a Pearson Chi squared test
|
This analyse will be realized at the end of the study (9 weeks after baseline)
|
|
Compare the percentage of using a supportive care professional judgement in regard to read and unread questionnaires by medical staff
Periodo de tiempo: This analyse will be realized at the end of the study (9 weeks after baseline)
|
Assess the percentage of using a supportive care when the medical staff read the completed questionnaire.
Assess the percentage of using a supportive care when the medical staff didn't read the completed questionnaire.
Then compare these values by using a T- test of Student.
|
This analyse will be realized at the end of the study (9 weeks after baseline)
|
|
Compare the percentage of using a supportive care professional judgement in regard to the function of the medical staff member
Periodo de tiempo: This analyse will be realized at the end of the study (9 weeks after baseline)
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Assess the percentage of using a supportive care when the medical staff who read the completed questionnaire is a doctor, a nurse, or an auxiliary nurse .
Then compare these values by using a T- test of Student
|
This analyse will be realized at the end of the study (9 weeks after baseline)
|
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Assess the percentage of requirement to the physician during the study
Periodo de tiempo: 4 to 6 weeks after baseline (by a phone call, at the same time than the hetero-questionnaire)
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Assess the percentage of requirement to the physician during the study by asking each patient (by phone call)
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4 to 6 weeks after baseline (by a phone call, at the same time than the hetero-questionnaire)
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Véronique FRASIE, Md, Centre PAUL STRAUSS
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
17 de septiembre de 2018
Finalización primaria (Actual)
5 de diciembre de 2018
Finalización del estudio (Actual)
18 de enero de 2019
Fechas de registro del estudio
Enviado por primera vez
14 de mayo de 2019
Primero enviado que cumplió con los criterios de control de calidad
14 de mayo de 2019
Publicado por primera vez (Actual)
15 de mayo de 2019
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
23 de mayo de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
21 de mayo de 2019
Última verificación
1 de mayo de 2019
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 2018-02
- 2018-A01425-50 (Otro identificador: ANSM)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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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