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Symptom Inventory for Gastrointestinal Stromal Tumors

9 de enero de 2020 actualizado por: M.D. Anderson Cancer Center

Symptom Burden in Patients With Gastrointestinal Stromal Tumors (GISTs)

The goal of this research study is to better understand the symptoms experienced by patients with GIST.

There are 3 parts to this study. In Part 1, participants will complete 1 set of interviews and questionnaires about GIST symptoms. In Part 2, the importance of some symptoms to patients with GIST will be rated by doctors, nurses, patients, and family caregivers. In Part 3, participants will complete questionnaires about GIST symptoms over 1 year.

You are being asked to take part in Part 3 of the study.

Descripción general del estudio

Descripción detallada

Symptom Questionnaires:

If you agree to take part in this study, you will complete questionnaires about symptoms you are having. You will be asked to fill these out 1 time a week during the first 2 months after surgery, 1 time a week during the first 3 months of a new therapy, and every 2 weeks at other times. The questionnaire will ask you to rate how severe your symptoms are and how the symptoms effect the activities of your daily life. The symptom questionnaire should take about 5 minutes to complete. You will complete the questionnaire during the first study visit and at your regular clinic visits.

Between clinic visits, you will be called every 1-2 weeks to complete the questionnaire using an automated telephone system. You can decide what time is most convenient for the automated phone system to call you. If you are not available when the automated system calls, it will call you again at a later time. If you are not reached by the automated phone system after several tries, the study staff will call you. You will be given a secure user name and identification number to use with the automated phone system. The study staff will teach you how to use the automated phone system.

At the clinic visit closest to 3 months after you start the study, you may be seen by a research staff member a second time 1 to 3 days after you completed the symptom questionnaire and asked to fill out the symptom questionnaire again. The research staff member may contact you by phone prior to this clinic visit to arrange times to meet you for the 2 assessments.

Quality-of-Life/Demographic Questionnaires:

At the first visit and the regular clinic visits, you will also rate your overall quality-of-life. This should take about 1 minute to complete.

At the first visit, you will also be asked some demographic questions (such as your age and marital status). Answering these questions should take about 1 minute.

Opinion Questionnaire:

If you are 1 of the first 40 patients enrolled in the study, you will be asked questions about your opinion of the symptom questionnaire at the clinic visit closest to 3 months after you start the study. For example, you will be asked if the symptom questionnaire was easy to understand and complete, and if there were any other questions that should be included. The study staff will use your opinion to decide if changes should be made to the questionnaire or if important symptom questions are missing from the questionnaire. This questionnaire should take about 5 minutes to complete.

Length of Study:

You will be on study for 1 year. You will be off study after you complete the last symptom questionnaire.

This is an investigational study.

Up to 188 participants will take part in this study. Up to 150 participants will be enrolled in Part 3 of this study. All will be enrolled at MD Anderson.

Tipo de estudio

De observación

Inscripción (Actual)

187

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Texas
      • Houston, Texas, Estados Unidos, 77030
        • University of Texas MD Anderson Cancer Center

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

UT MD Anderson Cancer Center Sarcoma and Surgical Oncology Clinics GIST Patients, their caregivers, doctors and nurses who are 18 years or older.

Descripción

Inclusion Criteria:

  1. 18 years of age or older (Patient and family caregiver only)
  2. Ability to speak and read English (All participants)
  3. Residing where IVR service is available (Part 3, Patient only)
  4. Diagnosis of GIST confirmed by pathological analysis (Patient only)
  5. Starting new treatment (either surgical or medical) and planning to be followed at M.D. Anderson Cancer Center (Part 3, Patient only)
  6. Written consent to participate (All participants)
  7. At least 3 months from start of initial treatment (surgical or medical) for GIST (Part 2, Patient only)
  8. Family caregiver also willing to receive packet for expert panel participation (Part 2, Patient only)
  9. Physician or nurse with at least 5 years experience caring for patients with GIST (Professional expert only)
  10. At least one publication in the last 5 years dealing with GIST (Physician professional expert only)
  11. Identification as a family caregiver by a patient with GIST (Family caregiver only)
  12. Patient also willing to receive packet for expert panel participation (Family caregiver only)

Exclusion Criteria:

  1. Medical condition or impaired performance status that would preclude participation in the study (Patient only)
  2. Diagnosis of active psychosis or severe cognitive impairment as determined by primary physician (Patient only)
  3. Active treatment (systemic drug therapy or radiation therapy) for a second malignancy (Patient only)

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Part 1
Patient interview and developmental questionnaires
10 minutes to complete 3 questionnaires for development of MDASI-GIST
Otros nombres:
  • encuesta
Each interview will take approximately 30 minutes.
Part 2
Content Expert Panel (doctors, nurses) + Patients and Caregivers Questionnaire Development
10 minutes to complete 3 questionnaires for development of MDASI-GIST
Otros nombres:
  • encuesta
Part 3
Patient MDASI-GIST Questionnaire
Every 4 weeks for one year
Otros nombres:
  • encuesta

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Questionnaire Responses to Symptom Inventory for Gastrointestinal Stromal Tumors
Periodo de tiempo: Patients will be followed on study for 1 year regardless of changes in disease stage or treatments.
Descriptive statistics used to assess the distributional characteristics and demographics of the study population and to report how patients rate symptom severity and interference with function.
Patients will be followed on study for 1 year regardless of changes in disease stage or treatments.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Colaboradores

Investigadores

  • Investigador principal: Loretta A. Williams, PhD, MSN, M.D. Anderson Cancer Center

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

29 de julio de 2010

Finalización primaria (Anticipado)

31 de julio de 2020

Finalización del estudio (Anticipado)

31 de julio de 2020

Fechas de registro del estudio

Enviado por primera vez

6 de agosto de 2010

Primero enviado que cumplió con los criterios de control de calidad

9 de agosto de 2010

Publicado por primera vez (Estimar)

10 de agosto de 2010

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

13 de enero de 2020

Última actualización enviada que cumplió con los criterios de control de calidad

9 de enero de 2020

Última verificación

1 de enero de 2020

Más información

Términos relacionados con este estudio

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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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