- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04066153
Patient Reported Unmet Needs for Function and Supportive Occupational- and Physiotherapy Rehabilitation Interventions
Patient Reported Unmet Needs for Function and Supportive Occupational- and Physiotherapy Rehabilitation Interventions in a Palliative Care Setting
Descripción general del estudio
Estado
Descripción detallada
Physical functioning is found to be an important predictor for survival and physical ability 'to do what one wants' affects quality of life in cancer patients in palliative care and their spouses. Despite this, physical functioning is reported as a neglected dimension in palliative care quality of life outcome measures, and advanced cancer patients report that they do not receive the help they need. The vast majority of patients with advanced cancer described unmet palliative care needs, and with the most frequently reported problems being; fatigue (73%), limitations doing physical activities (65%), limitations in work and daily activities (58%), worry (58%), difficulties with sexuality (54%), pain (52%) and problems with concentration (43%). Furthermore, limitations in physical functioning and physical activity is a leading cause of distress and psychological problems a rehabilitative approach in palliative care integrated in the interdisciplinary interventions to the patients must be maintained throughout the entire illness trajectory from diagnosis through treatment, rehabilitation and palliative care to address such problems.
However, prevalence of patient unmet needs and reported physical functioning and performance is reported to differentiate largely between palliative units.
In order to address the functional needs of patients receiving specialist palliative care studies of their specific needs are required. Therefore, the aim of this study is to investigate the patient reported unmet needs for function and supportive occupational- and physiotherapy rehabilitation interventions in the palliative unit at Copenhagen University Hospital, Rigshospitalet. Furthermore, we aim to investigate if observations, additional disease-specific patient reported outcomes and assessment of physical function and performance can support the unmet needs.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Copenhagen, Dinamarca
- Rigshospitalet
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria :
All adult patients (≥ 18 years) referred to the Palliative Care Unit at Copenhagen University Hospital, Rigshospitalet.
Exclusion Criteria:
Inability to read and understand Danish
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Unmet physical functioning needs
Periodo de tiempo: At baseline
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The Three-Levels-of-Needs Questionnaire (3LNQ)
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At baseline
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Lower body physical function
Periodo de tiempo: At baseline
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30 seconds Sit-To-Stand test
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At baseline
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Hand grip strength
Periodo de tiempo: At baseline
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Maximum strength test by handgrip dynamometer
|
At baseline
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Walking endurance
Periodo de tiempo: At baseline
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Six Minute Walking Test
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At baseline
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Health-related quality of life
Periodo de tiempo: At baseline
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EORTC QLQ-C30
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At baseline
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Overall distress
Periodo de tiempo: At baseline
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Distress thermometer
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At baseline
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Psychological distress
Periodo de tiempo: At baseline
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Hospital Anxiety and Depression Scale (HADS)
|
At baseline
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Sleep quality
Periodo de tiempo: At beseline
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Pittsburgh Sleep Quality Index (PSQI)
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At beseline
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Level of fatigue
Periodo de tiempo: At baseline
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Functional Assessment of Cancer Therapy - Fatigue (FACT-F) 13 item fatigue subscale
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At baseline
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Patients self-perception of performance in everyday living
Periodo de tiempo: At baseline
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The Canadian Occupational Performance Measure (COPM)
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At baseline
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Physical activity level
Periodo de tiempo: At baseline
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International Physical Activity Questionnaire (IPAQ) short form
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At baseline
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jan Christensen, Department of Occupational- and Physiotherapy, Rigshospitalet
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
- 2018-418 6670
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.
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