Supportive Cancer Care Networkers (SCAN) (SCAN)
Supportive Cancer Care Networkers - a Prospective Randomized Controlled Multi-center Trial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Patients with colorectal cancer in Germany today are exposed to several Problems related to care continuity and access to health care professionals. In order to increase the utilization of adjuvant therapies, patients in the intervention group are offered an additional nursing intervention in the period between discharge after inpatient treatment and the beginning of adjuvant therapy. This includes a telephone follow-up conducted according to guidelines serving to disclose patients' current supportive needs in order to determine potential intervention approaches as early as possible. Hence, the intervention aims to motivate patients not to discontinue the treatment. An early detection of therapy-related physical and psychological impairments aims at optimizing treatment management.
Patients in the intervention group therefore are visited by nursing staff specialized in cancer care (Supportive Cancer Care Networkers, SCAN) during their in-patient stay and are informed about the intervention. An assignment for the SCAN is to support patients in getting access to health care services (e.g. specialists). Patients are given certain information, as for example contact to specialists, voluntary services and the next steps and appointments of the treatment plan are discussed. Within a consultation at the day before hospital discharge, the SCAN takes up the contact information and appoints weekly telephone consultations for the time up to the adjuvant therapy. The SCAN hands out information materials and explains the study documents, as for example patient-held records (PHR) in order to improve therapy compliance.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Saxony
-
Leipzig, Saxony, Alemania, 04177
- Diakonissen-Krankhenhaus Leipzig
-
-
Saxony-Anhalt
-
Aschersleben, Saxony-Anhalt, Alemania, 06449
- AMEOS Klinikum Aschersleben-Staßfurt GmbH
-
Dessau, Saxony-Anhalt, Alemania, 06846
- Diakonissenkrankenhaus Dessau gGmbH
-
Halle, Saxony-Anhalt, Alemania, D-06112
- University Hospital Halle
-
Lutherstadt Eisleben, Saxony-Anhalt, Alemania, 06295
- HELIOS Klinik Lutherstadt Eisleben
-
Magdeburg, Saxony-Anhalt, Alemania, 39130
- Klinikum Magdeburg gGmbH
-
Sangerhausen, Saxony-Anhalt, Alemania, 06526
- HELIOS Klinik Sangerhausen
-
Schönebeck, Saxony-Anhalt, Alemania, 39218
- AMEOS Klinikum Schönebeck GmbH
-
-
Saxony-Anhat
-
Merseburg, Saxony-Anhat, Alemania, 06217
- Carl-von-Basedow-Klinikum Merseburg
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- colorectal carcinoma (ICD-10: C18, C19, C20)
- indication for adjuvant chemo therapy following S3-Guideline on colorectal Cancer or physician-directed
- living in Saxony-Anhalt
- ECOG-Performance Status <3
- prospective further life expectancy of more than three months
Exclusion Criteria:
- unable to read or understand German properly
- any contra-indication for adjuvant therapy as described in the S3-Guideline such as inadequate liver, bone marrow, and kidney function or coronary heart disease (NYHA III-IV).
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 |
|---|---|
|
Sin intervención: usual care
routine care and case management
|
|
|
Experimental: SCAN-Intervention
|
The Supportive Cancer Care Networkers intervention (SCAN) consists of an additional telephone support and symptom-related out-patient care management through Oncology Nursing.
The SCAN intervention assesses patients' resources and barriers in utilizing health care services in order to meet their individual needs adequately and supports maintenance of therapy compliance.
Thus, the SCAN offers a comprehensive mirroring the patients' medical and psychosocial care needs across changing sectors of health care.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
proportion of eligible patients undergoing adjuvant chemo therapy
Periodo de tiempo: 8 weeks after hospital discharge/ chrirurgical resection
|
8 weeks after hospital discharge/ chrirurgical resection
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
disease-free survival
Periodo de tiempo: 8 month after hospital discharge/ chrirurgical resection
|
8 month after hospital discharge/ chrirurgical resection
|
|
|
Health-related Quality of Life
Periodo de tiempo: 8 weeks & 8 month after hospital discharge/ chrirurgical resection
|
using the EORTC QLQ-C30 & CR-29
|
8 weeks & 8 month after hospital discharge/ chrirurgical resection
|
|
symptom burden
Periodo de tiempo: 8 weeks & 8 month after hospital discharge/ chrirurgical resection
|
using the M.D. Anderson Symptom inventory
|
8 weeks & 8 month after hospital discharge/ chrirurgical resection
|
|
Distress
Periodo de tiempo: 8 weeks & 8 month after hospital discharge/ chrirurgical resection
|
using the Distress-Thermometer
|
8 weeks & 8 month after hospital discharge/ chrirurgical resection
|
|
supportive care needs
Periodo de tiempo: 8 weeks & 8 month after hospital discharge/ chrirurgical resection
|
using the Supportive Needs Questionnaire-37 (FU-T)
|
8 weeks & 8 month after hospital discharge/ chrirurgical resection
|
|
Quality of inpatient care
Periodo de tiempo: at Baseline
|
using the EORTC INPATSAT-32
|
at Baseline
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Margarete Landenberger, Prof. Dr., Martin-Luther-University Halle-Wittenberg, Medical Faculty, Institute for Health and Nursing Science
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
- Humanos
- Calidad de vida
- Adulto
- Envejecido
- Resultado del tratamiento
- Accesibilidad a los Servicios de Salud
- Factores socioeconómicos
- Mayores de 80 años
- Aseguramiento de la Calidad, Cuidado de la Salud
- Psicooncología
- Población rural
- Neoplasias Colorrectales/*terapia farmacológica/*secundaria
- Necesidades de atención de apoyo
- Atención Primaria de Salud/*métodos
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 01GY1143
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. .