Group-based or Individual Information About Disease and Treatment Plan
Cancer Patients' Knowledge and Satisfaction After Group-based or Individual Information About Their Disease and Treatment Plan
The main aim of the current study is to investigate whether the addition of a standardized,group-based educational program to the information provided by health care personnel improves cancer patients' knowledge level about their disease, planned treatment and common side-effects of the treatment.
Secondary aims are to investigate if the addition of the educational program increases the likelihood of completing treatment as planned, reduces level of anxiety, reduces the frequency of serious side effects, increases patient reported health related quality of life, and increases the degree of patient satisfaction with respect to how they have received the information before, during and after treatment.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
There are strong indications that group-based information provides better information for cancer patients about their disease, treatment options - and potential benefits and side effects of the planned therapy than information provided during a regular doctor consultation.
The investigators believe that standardizing and repeating the information as well as having more time for questions in an open environment for reflections will improve the amount of information patients can perceive. Furthermore, all patients will be given written information.
Better-informed patients may be more motivated and may contact health care personnel earlier than other patients when they develop side effects. This may reduce the risk of serious treatment-related complications and increase the chances of patients completing the planned treatment. But none have compared to what extent an organization like Vardesenteret improves the patients' knowledge and whether patients are more satisfied with these methods for informing them. Results from studies on the influence of patient anxiety and distress on patient's abilities to perceive information are conflicting.Two large groups of relatively homogenous cancer patients are patients with lower-stage breast cancer patients who are eligible for adjuvant chemotherapy and patients with localized prostate cancer eligible for curative radiotherapy.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
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Trondheim, Noruega
- St Olavs 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:
- Breast cancer patients that are candidates for adjuvant chemotherapy after surgery.
- Prostate cancer patients that are candidates for curative radiotherapy
- Signed informed consent
- Patient expected to be able to complete the planned treatment and the study procedures
- 18years or older
Exclusion Criteria:
-Patients not fulfilling inclusion criteria
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Group and Individual information
The patients will receive two 1.5-2 hour standardized validated group information sessions in addition to regular information from their doctors and nurses.
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The patients will receive two 1.5-2 hour standardized validated group information sessions in addition to regular information from their doctors and nurses.
|
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Sin intervención: Individual information
Standard information about disease and treatment from doctor and nurse given at 2 occasions.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Knowledge
Periodo de tiempo: 1 week
|
Knowledge questionnaires specially made for the study.
Constructed as statements with response categories; correct, false and don´t know.
|
1 week
|
|
Knowledge
Periodo de tiempo: 2 weeks
|
Knowledge questionnaires specially made for the study.
Constructed as statements with response categories; correct, false and don´t know.
|
2 weeks
|
|
Knowledge
Periodo de tiempo: 9 weeks
|
Knowledge questionnaires specially made for the study.
Constructed as statements with response categories; correct, false and don´t know.
|
9 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Quality of Life
Periodo de tiempo: 9 weeks
|
European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire C30
|
9 weeks
|
|
Patients Subjective state of information
Periodo de tiempo: 1 week
|
European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire INFO 25
|
1 week
|
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Patients Subjective state of information
Periodo de tiempo: 2 weeks
|
European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire INFO 25
|
2 weeks
|
|
Patients Subjective state of information
Periodo de tiempo: 9 weeks
|
European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire INFO 25
|
9 weeks
|
|
Anxiety
Periodo de tiempo: 1 week
|
STAI-State and Trait Anxiety Inventory
|
1 week
|
|
Anxiety
Periodo de tiempo: 2 weeks
|
STAI-State and Trait Anxiety Inventory
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2 weeks
|
|
Anxiety
Periodo de tiempo: 9 weeks
|
STAI-State and Trait Anxiety Inventory
|
9 weeks
|
|
Adverse events
Periodo de tiempo: 2 weeks
|
CTCEA, Common Terminology Criteria for Adverse Events
|
2 weeks
|
|
Adverse events
Periodo de tiempo: 9 weeks
|
CTCEA, Common Terminology Criteria for Adverse Events
|
9 weeks
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Stein Kaasa, MD, Prof., St Olavs Hospital - Trondheim University Hospital and PRC, European Palliative Care Research Center
- Director de estudio: Ola Berger, MD, St Olavs Hospital - Trondheim University Hospital and PRC, European Palliative Care Research Center
- Silla de estudio: Bjørn H Gønberg, MD, PhD, St Olavs Hospital - Trondheim University Hospital and PRC, European Palliative Care Research Center
- Silla de estudio: Kari Sand, Cand Philol, PRC, European Palliative Care Research Center
- Silla de estudio: Jo Å Lund, MD, PhD, St Olavs Hospital - Trondheim University Hospital and PRC, European Palliative Care Research Center
- Silla de estudio: Jon H Loge, MD, Prof., National Resource Centre for Studies of Late Effects after Cancer Treatment, Oslo University Hospital, Radiumhospitalet, Oslo, Norway; Department of Behavioral Sciences in Medicine, University of Oslo
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- REK2012/1238
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