Evaluating the Effects of Psycho-oncological Education on Distress and Quality of Life in Solid Tumor Cancer Patients
Evaluating the Effects of Psycho-oncological Education on Distress and Quality of Life in Solid Tumor Patients Who Have Received and Completed Chemotherapy Treatment With Curative Intent. A Pilot Study.
Descripción general del estudio
Descripción detallada
Solid tumor cancer patients who have completed chemotherapy with curative intent experience psychological distress. As a result these patients experience poorer quality of life (QOL), emotional vulnerability and unnecessary emotional suffering.
Purpose: To determine whether the implementation of a nurse driven psycho-oncological educational session will decrease psychological distress levels and improve QOL among solid tumor cancer patients who have received and completed chemotherapy with curative intent.
Methods: A randomized clinical trial (RCT) consisting of 28 eligible patients at Sibley Memorial Hospital will be used to compare the effect of psycho-oncological education to treatment as usual in reducing psychological distress and improving quality of life. The intervention group will receive one 60 minute session of psycho-oncological education. The comparison group will receive usual care only which includes a general information session offered prior to any treatment which addresses broad side-effects of treatment, an overview of the treatment process and identification of additional resources. Participants will be assessed for psychological distress and QOL levels at baseline and two weeks after the intervention.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- non-race specific
- solid tumor cancer patient
- completed chemotherapy with curative intent
Exclusion Criteria:
- diagnosis of cancer prior to cancer they are being treated for
- distress score of 8 or greater
- diagnosed with a psychiatric disorder
- diagnosed with lymphoma or leukemia
- in need of immediate crisis support
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 |
|---|---|
|
Experimental: Psycho-oncological education
One 60 minute psycho-oncological education session on late effects, fatigue and stress management.
|
One 60 minute psycho-oncological educational session on stress management, late effects and fatigue.
|
|
Sin intervención: Usual Care
Usual care includes completion of a symptom checklist by the nurse practitioner
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Distress Thermometer (self-reported distress levels by 11 point scale) Change is being assessed
Periodo de tiempo: at baseline & two weeks after intervention
|
Self reported distress levels at baseline and two weeks after the intervention.
Scale is 11-points from 0(no distress) to 10 (extreme distress)
|
at baseline & two weeks after intervention
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
World Health Organization Quality of Life BREF (WHOQOL-BREF) Change is being assessed.
Periodo de tiempo: at baseline & two weeks after intervention
|
Self- report, 24 question scale representing 6 domains related to quality of life.
Quality of life to be measured at baseline and two weeks post intervention.
|
at baseline & two weeks after intervention
|
Colaboradores e Investigadores
Investigadores
- Investigador principal: Channing Paller, MD, Johns Hopkins University
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
Otros números de identificación del estudio
- SIB14142
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