- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02603692
Health Related Quality of Life in Pediatric Central Nervous System (CNS) Tumors: A Feasibility Study Utilizing PROMIS (PROMIS-QOL)
In this research study the investigators want to learn more about the quality of life before, during and after cancer treatment in patients with central nervous system brain tumors. Often CNS tumors and cancer treatment can cause many physical and emotional problems and side effects. Some of these problems and treatment side effects can cause a change in a patient's qualify of life and overall well-being. Quality of life questionnaires are used to measure well-being and ability to carry out daily activities by asking patients to answer several questions about their physical, emotional, and social well-being.
In this research study we want to find out if patient's answers to these questions change over the course of your treatment. We also want to see if doctors and nurses can use these answers to the questions to help patients feel better and increase their activity during cancer treatment.
Descripción general del estudio
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Ohio
-
Cincinnati, Ohio, Estados Unidos, 45229
- Cincinnati Children's Hospital Medical Center
-
-
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
Eligibility Criteria
- Patient must have diagnosis of a CNS tumor (newly diagnosed, relapsed, refractory, or progressed) and scheduled to receive a new therapy including surgery, chemotherapy and/or radiation therapy.
- Age: 5 -35 years of age.
- The planned therapy must include at least one disease evaluation with the first 90 days of therapy. The patient and family must intend to return to Cincinnati Children's Hospital at least once in the next 90 days.
- Each subject may only participate once in this study.
- The subject and/or his /her parent/guardian must be fluent in English. At the time of study enrollment, the medical care of the subject must be managed by an attending oncologist at Cincinnati Children's Hospital.
- The subject must have a minimum performance score of 50% (either Lansky or Karnofsky) as documented in their medical record by clinical provider (MD or nurse practitioner). Appendix I.
- A patient / family must be approached to participate in this study within 28 days of the administration of the first dose of the associated therapy or surgery.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
---|---|
Pediatric group (ages 8-17)
PROMIS pediatric domains for emotional distress (anxiety and depression), physical function (fatigue, pain interference, mobility and upper extremity), and peer relations
|
PROMIS questionnaires completed every 3 months for up to 2 years.
|
Adult group (ages 18-35)
PROMIS adult domains.
To reduce respondent burden, the multi-form design will be used which includes the short form of physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference and pain intensity.
|
PROMIS questionnaires completed every 3 months for up to 2 years.
|
Parent/guardian proxy
Parent/guardian will complete the parental proxy PROMIS instruments based on corresponding child age (ages 5 to 17 years)
|
PROMIS questionnaires completed every 3 months for up to 2 years.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Number of participants to complete at least 75% of the Patient Reported Outcomes Measurement Information System (PROMIS) tool in pediatric and adult patients with brain tumors.
Periodo de tiempo: 24 months
|
24 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Mariko DeWire, MD, Children's Hospital Medical Center, Cincinnati
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 (Actual)
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
- PROMIS-QOL
- 2014-5742 (Otro identificador: Cincinnati Children's Hosp Med Ctr IRB#1)
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. .
Ensayos clínicos sobre Neoplasias Cerebrales
-
University of Dublin, Trinity CollegeDesconocidoAtletas de élite retirados de Brain Health
-
Assiut UniversityTerminadoMorfometría basada en Brain Voxel en ManiaEgipto
Ensayos clínicos sobre PROMIS-QOL
-
Massachusetts General HospitalTerminado
-
Julia FinkelChildren's National Research Institute; Arizona State UniversityTerminadoEnfermedades hematológicas | Anemia | Anemia drepanocítica | Anemia de células falciformes | Anemia HemolíticaEstados Unidos
-
Chinese University of Hong KongReclutamientoCarrera | Enfermedades Cerebrales | Actitud de Salud | Isquemia cerebral | Demencia | Enfermedad de Alzheimer | Envejecimiento Saludable | Apoplejía Isquémica | Accidente cerebrovascular agudo | Salud Conocimiento, Actitudes, Práctica | Actitud del personal de salud | Síndrome de accidente cerebrovascularHong Kong
-
Spanish Breast Cancer Research GroupNovartis PharmaceuticalsTerminadoCarcinoma de mama metastásico al huesoEspaña
-
Bezirkskrankenhaus St. Johann in TirolTyrolean Arthroplasty RegistryReclutamientoOsteonecrosis | Artrosis, Cadera | Fracturas del cuello femoral | Artropatía de cadera | Enfermedad de PerthesAustria
-
Assistance Publique Hopitaux De MarseilleReclutamientoParálisis Supranuclear ProgresivaFrancia
-
GlaxoSmithKlineHealth Research Associates, Inc.TerminadoNeoplasiasEstados Unidos
-
Allina Health SystemTerminadoCuidados paliativos | Columna vertebral | Oncologia medica | Atención primaria | Medicina Integrativa | Cardiología | Medicina Física y Rehabilitación | Ortopedía | Medicina PulmonarEstados Unidos
-
Centre Hospitalier Universitaire DijonTerminado
-
University of RochesterAmerican Orthopaedic Foot and Ankle SocietyTerminado