- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00507351
Ambulatory Cancer Pain Management: A Feasibility Study
The primary purpose of this study is to examine the feasibility of collecting pain and other symptom data in outpatient treatment centers across multiple institutions in the Texas Medical Center (TMC). We will also examine the prevalence and severity of cancer-related pain and begin to identify other commonly reported symptoms in outpatient settings. Factors that interfere with management of pain will also be examined. Additionally, the study will explore patient satisfaction with pain management and pain education in outpatient settings. The specific aims of this study include:
Primary Objective:
-Explore the feasibility of a collaborative effort by oncology nurses to collect pain and symptom data across multiple institutions that care for ambulatory cancer patients in the TMC.
Secondary Objectives:
- Describe the prevalence and severity of pain and other symptoms in persons with breast, colorectal, lung, or prostate cancer who are receiving chemotherapy in the outpatient setting.
- Describe factors that interfere with adequate pain management in these patients.
- Examine patient satisfaction with pain management and patient education about pain management.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
You will be asked to complete 3 questionnaires that will take a total of about 20 minutes to complete. Your name or medical record number will not appear on the questionnaires. You will be assigned a study subject code number. The study chair will keep a file that links your name to the code.
The first questionnaire will ask for basic demographic information (such as gender, ethnicity, and education) and your current chemotherapy and pain medications. If you cannot remember the names of these medications, researchers will locate them in your M. D. Anderson medical record.
The second questionnaire asks you to rate your pain and a variety of symptoms (for example, fatigue and nausea).
The last questionnaire includes 3 sections. The first section asks about your beliefs about pain and its treatment. The second part asks for your opinion about your pain management and about the education you have received about pain management. On the last page, you will be asked to use a picture of the outline of a body to show the researchers where you have pain.
Once you have completed these questionnaires, you will be considered off-study.
This is an investigational study. Up to 125 patients will take part in this study. Up to 35 will be enrolled at M. D. Anderson.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Texas
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Houston, Texas, Estados Unidos, 77030
- U.T.M.D. Anderson Cancer Center
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Houston, Texas, Estados Unidos, 77030
- Memorial Hermann Hospital
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Houston, Texas, Estados Unidos, 77030
- Methodist Hospital
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Houston, Texas, Estados Unidos, 77030
- Michael E. DeBakey Veterans Administration Medical Center
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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:
- Diagnosis of breast, colorectal, lung, or prostate cancer (any histological type).
- Currently undergoing chemotherapy.
- Age 18 or older.
- Able to read, write, and speak English.
- Able to understand the purpose of this study.
- Must be a patient at one of the four participating institutions.
- Must be receiving the 2nd, 3rd, or 4th cycle of chemotherapy.
Exclusion Criteria:
- Receiving chemotherapy in preparation for a bone marrow or stem cell transplant
- Received a bone marrow or stem cell transplant
- Age 17 or younger
- Receiving weekly chemotherapy.
- Receiving hormonal therapy alone.
- Receiving radiation or chemoradiation.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
---|---|
Cancer Pain Management
Patients receiving chemotherapy for breast, colon, lung, or prostate cancer.
|
3 questionnaires that will take 20 minutes total to complete.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Pain and symptom data across multiple institutions
Periodo de tiempo: Survey data collection taking 30 minutes, collecation accomplished at multiple sites over 3 years
|
Survey data collection taking 30 minutes, collecation accomplished at multiple sites over 3 years
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Anita Broxson, RN, M.D. Anderson Cancer Center
Publicaciones y enlaces útiles
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
- Enfermedades del Sistema Digestivo
- Neoplasias
- Neoplasias urogenitales
- Neoplasias por sitio
- Dolor
- Manifestaciones neurológicas
- Neoplasias Gastrointestinales
- Neoplasias del Sistema Digestivo
- Enfermedades Gastrointestinales
- Neoplasias Genitales Masculinas
- Enfermedades prostáticas
- Enfermedades del Colon
- Enfermedades intestinales
- Neoplasias Intestinales
- Enfermedades Rectales
- Neoplasias prostáticas
- Neoplasias colorrectales
- Dolor por cáncer
Otros números de identificación del estudio
- 2005-0841
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. .
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