- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00595218
Patient Preference Survey for Radiation Oncologists
How Can Radiation Oncologists Better Serve Their Patients? A Randomized Study to Determine Whether Radiation Oncologists Can Improve Patient Satisfaction by Attempting to Meet Their Patients' Preferences
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
An instrument, a questionnaire, previously developed by our group (IRB# 0512075) will be used to determine these cancer patient/subjects' preferences for the following six categories (see Appendix 1)
- How should the radiation oncologist address them (by their first name or Mr/Mrs)?
- Should the radiation oncologists wear a white coat?
- Should the radiation oncologist discuss their prognosis and survival with them?
- Should the radiation oncologist have physical contact with their patient (hold hand or hug the patient.)?
- Should the radiation oncologist inquire about their religious beliefs to help cope with their cancer?
- Should the radiation oncologist use basic, lay language or more technical terminology when describing the radiation treatment?
This research study will consist of a randomized study of breast, prostate, and lung cancer patients/subjects receiving radiation therapy at the University of Pittsburgh Cancer Institute and UPMC Cancer Centers who will complete this questionnaire. Radiation therapy can be either for definitive or palliative therapy. This creates six distinct cohorts in the study (definitive breast, prostate, and lung cancer, palliative breast, prostate, and lung cancer) that provide an adequate representation of the cancer patient/subject cohorts that receive radiation therapy.
Patients/subjects will answer this questionnaire at the time of the initial consultation with the radiation oncologist (before meeting the radiation oncologist), once midway during radiation therapy, and at the completion of the radiation treatment. At completion, there will be additional questions used from a modified version of an established validated instrument currently being used at the University of Pittsburgh Cancer Institute to assess patient/subject satisfaction. (Appendix 2). Participants will rate the importance of each item on a 5-point scale: strongly disagree, disagree, neither agree nor disagree, agree, or strongly agree. They will also use a parallel ranking from 0-100 on each item to more finely assess the satisfaction differences for the survey in Appendix 2 only.
After subjects answer the questionnaire at time of initial consultation, the subject will then be randomized to either an experimental or control group. In the experimental group, the radiation oncologist participants will read their patient's responses to this questionnaire prior to their initial consultation and try to adapt to the subject's (patient's) preferences. In the control group, the radiation oncologist participant will be blinded to the results of their patient's questionnaire. At the end of treatment, the radiation oncologists who viewed their patient preferences will have to answer the following question according to the 5 point scale system: "Did knowledge of your patient's preferences influence your behavior?" The radiation oncologist participant will not have access to the patient satisfaction survey.
The duration of study per patient participant will the duration of the radiation treatment which has an average length of 4 weeks. A subject accrual of 500 patient participants and 30 radiation oncologist participants is expected at the University of Pittsburgh Cancer Institute and UPMC Cancer Centers, consisting of 19 Radiation Oncology centers across Western Pennsylvania. The expected duration of the entire study is 1 year. The data will be collected through these instruments to generate a database collected in our database management system. The data will be coded and maintained by the clinical study coordinator.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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-
Pennsylvania
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Pittsburgh, Pennsylvania, Estados Unidos, 15213
- UPMC Cancer Centers
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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:Any Patient/subject (adult male or female) with prostate or breast or lung cancer (Primary or Metastatic) who is scheduled to receive radiation therapy at one of the UPMC Cancer Centers
- Patient/subject must receive radiation treatment in addition to consultation with the Radiation Oncologist
- Patient/subject must meet with radiation oncologist at least one day per week while receiving radiation therapy.
- Any attending radiation oncologist whose patient is enrolled in this study
Exclusion Criteria:
- Patient/subject under age 18 If subject previously underwent this study, even if the previous study was for a different diagnosis. Subjects can only undergo this study once.
Patients/subjects who do not have the functional and mental capacity to independently answer the questionnaire.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Sin intervención: 1
Patients whose radiation oncologist are blinded to their patient preference survey results
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Comparador activo: 2
Patients whose radiation oncologist are not blinded to their patient preference survey results
|
Access to initial Patient preference survey results
Knowledge of Patient Preference Results
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Did knowledge of patient preference improve patient satisfaction
Periodo de tiempo: Length of radiation treatment
|
Length of radiation treatment
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Patient preferences regarding their radiation oncologists
Periodo de tiempo: Length of radiation treatment course
|
Length of radiation treatment course
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Ajay Bhatnagar, MD, University of Pittsburgh
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 (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- PittRadOnc
- ASTRO grant
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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