Early, Integrated, Specialized Palliative Rehabilitation
A Randomized, Controlled Phase III Study of Integrated, Specialized Palliative Rehabilitation for Patients With Newly Diagnosed Non-resectable Cancer.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
300 patients with newly diagnosed advanced cancer are planned to be enrolled. They wil be randomized at a 1:1 ratio to standard oncology treatment or standard oncology treatment plus a 12-week individually customized palliative rehabilitation program.
The intervention takes place in a specialized palliative setting and is planned after an individual consultation with the patient and his relatives. It can be adjusted during the 12 weeks according to the patient's symptoms and needs. All or part of the palliative rehabilitation program is organized as weekly group sessions at the hospital. The group sessions consist of lectures and debates followed by physical training. Professionals involved in the group sessions are doctors, nurses, physiotherapists, psychologists, occupational therapists, social workers, dietitians, and a priest.
If needed, the patient and/or his relatives can also be offered individual sessions.
All contacts with the patients or his relatives during the 12 weeks are registered in order to document the intervention retrospectively.
The intervention is evaluated using questionnaires. All participants receive a questionnaire at baseline and after 6 and 12 weeks. The questionnaire consists of EORTC-QLQ-C30 (a validated questionnaire developed to assess the quality of life of cancer patients) and HADS (the validated Hospital Anxiety and Depression Scale). At baseline the questionnaire is extended with the question: "Which of the following problems/ symptoms do you need help with the most?". The patients can choose between 12 defined problems matching 12 of the scales of EORTC-QLQ-C30 or "none of the above". The answer given by the patient is labeled "The Primary Problem".
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Vejle, Dinamarca, DK-7100
- Department of Oncology, Vejle Hospital
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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:
Participants must:
- be diagnosed with non-resectable cancer less than 8 weeks before inclusion. For patients with prostate cancer they must be refered to systemic oncology treatment for the first time less than 8 weeks before inclusion.
- be fit to receive standard oncology treatment and accepting treatment
- read and understand Danish
- sign informed consent
Exclusion Criteria:
- contact with a specialized palliative unit within the last year before inclusion
- unability to cooperate in the study
- missing informed consent
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Sin intervención: Control arm
150 patients will receive standard oncology treatment.
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Comparador activo: Intervention arm
150 patients will receive standard oncology treatment alongside a 12-week specialized palliative rehabilitation program
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12-week individually customized, specialized palliative rehabilitation program
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Effect of the intervention on "The Primary Problem" chosen by the patient.
Periodo de tiempo: 6 and 12 weeks
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Comparing change from baseline to the weighed average of the 6 and 12-week follow-up of the scale in EORTC-QLQ-C30 that correlates to "The Primary Problem" of the patient (measured as area under the curve (AUC) of the change).
If the patient has not chosen a "Primary Problem" the same measurement is done with the general health related quality of life scale.
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6 and 12 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Effect of the intervention on all symptoms and problems present in the EORTC-QLQ-C30 Questionnaire
Periodo de tiempo: 6 and 12 weeks
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Comparing change from baseline to the weighed average of the 6 and 12 week follow-up of all the scales of EORTC-QLQ-C30 (measured as area under the curve (AUC) of the change).
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6 and 12 weeks
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Effect of the intervention on worries and symptoms of anxiety and depression
Periodo de tiempo: 6 and 12 weeks
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Comparing HADS-scores in the two arms
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6 and 12 weeks
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All cause mortality
Periodo de tiempo: 3 months after last data collection
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Comparing mortality in the two arms using Kaplan-Meier survival curve.
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3 months after last data collection
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Economic consequences
Periodo de tiempo: 3 months after last data collection
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Comparing health related expenses in the two arms using register information about admissions to hospitals, visits with family doctors, emergency rooms etc.
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3 months after last data collection
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Henrik Jensen, Assoc. prof., Vejle Hospital
Publicaciones y enlaces útiles
Publicaciones Generales
- Nottelmann L, Groenvold M, Vejlgaard TB, Petersen MA, Jensen LH. Early, integrated palliative rehabilitation improves quality of life of patients with newly diagnosed advanced cancer: The Pal-Rehab randomized controlled trial. Palliat Med. 2021 Jul;35(7):1344-1355. doi: 10.1177/02692163211015574. Epub 2021 May 17.
- Nottelmann L, Groenvold M, Vejlgaard TB, Petersen MA, Jensen LH. A parallel-group randomized clinical trial of individually tailored, multidisciplinary, palliative rehabilitation for patients with newly diagnosed advanced cancer: the Pal-Rehab study protocol. BMC Cancer. 2017 Aug 23;17(1):560. doi: 10.1186/s12885-017-3558-0.
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 (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
Otros números de identificación del estudio
- Pal-Rehab
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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