Stress-Immune Response and Cervical Cancer
Psychosocial Telephone Counseling (PTC)
Neoplasias del Cuello Uterino+9
+ Enfermedades Urogenitales
+ Enfermedades del cuello uterino
Otro tipo de estudio
Resumen
Fecha de inicio: 1 de agosto de 2004
Fecha en la que se inscribió al primer participante.OBJECTIVES: * Compare quality of life (QOL) at baseline and changes in QOL, immune response, and neuroendocrine parameters over time in patients who have completed treatment for stage I-III cervical cancer receiving psychosocial telephone counseling vs usual care. * Correlate psychosocial measures with immunologic stance. OUTLINE: This is a randomized, controlled, parallel-group study. Patients are randomized to 1 of 2 intervention arms. * Arm I: Patients undergo psychosocial telephone counseling comprising 5 weekly sessions and a 1-month follow-up session to learn strategies for reducing stress. * Arm II: Patients undergo usual care for approximately 4 months. All patients complete questionnaires and Quality of life assessment at baseline and at 4 months. They also undergo saliva and blood sample collections at baseline and at 4 months for neuroimmune studies. PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 36 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Otro Tipo de Estudio
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Mujer
Sexo biológico de los participantes elegibles para inscribirse.De 18 a 120 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
INCLUSION CRITERIA Disease Characteristics: * Diagnosis of cervical cancer between the past 3-15 months * Stage I-III disease * Completed therapy for cervical cancer ≥ 1 month ago * Not receiving ongoing treatment * More than 4 weeks since prior immunotherapy * More than 30 days since prior investigational drugs * No prior biological response modifier * No concurrent corticosteroids * No concurrent immunosuppressive therapy Patient Characteristics: * Resident of Orange, San Diego, or Imperial County in California * English or Spanish speaking * No serious acute or chronic illness * Has access to a telephone EXCLUSION CRITERIA Disease Characteristics: * Stage IV cervical carcinoma * Have undergone previous treatment with a biological response modifier (inferferons, interleukins) or prior immunotherapy within four weeks of study enrollment * Used investigational drugs within 30 days of execution of the informed consent * Required corticosteroids or were under immune suppression for any reason including an organ allograft or HIV infection * Patients with metastatic disease or ongoing treatment * Any acute or chronic illness, including autoimmune states, as judged clinically significant by the investigators Patient Characteristics: * Non-English or Spanish speakers
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Un solo grupo de intervención está designado en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalObjetivos del Estudio
Objetivos Primarios
Centros del Estudio
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UCI, Health Policy and Research Center
Irvine, United StatesAbrir UCI, Health Policy and Research Center en Google Maps