Phone or Email Reminder in Increasing Vaginal Dilator Use in Patients With Gynecologic Cancers Undergoing Brachytherapy
16 de agosto de 2021 actualizado por: Stanford University
Phase I Pilot Study Evaluating Vaginal Dilator Use and Toxicity Following Vaginal Brachytherapy
This randomized, pilot phase I trial studies whether phone or email reminders increases vaginal dilator use in patients with endometrial, cervical, or vaginal cancers after they undergo brachytherapy.
Brachytherapy is a type of internal radiation which uses radioactive material placed directly into or near a tumor to kill tumor cells.
A reminder program may help increase use of vaginal dilators and decrease long-term side effects following brachytherapy.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Descripción detallada
PRIMARY OBJECTIVES:
I. Evaluate whether vaginal dilator adherence is improved with additional reminder phone calls and/or email reminder survey.
SECONDARY OBJECTIVES:
I. Evaluate whether there are differences in the length of vaginal canal between the non-intervention and intervention groups. Evaluate rates of gynecologic, urinary, and gastrointestinal toxicity.
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM I: Patients receive no additional reminders.
ARM II: Patients receive a reminder email survey every 2 weeks for 1 year after completing radiation.
ARM III: Patients receive a reminder email survey as in Arm I and 4 additional phone calls at 4-8 weeks, 3-5 months, 7-8 months, and 10-11 months during their first year of follow-up.
After completion of study, patients are followed up at 10-14 weeks, 5-7 months, 8-10 months, 11-13 months, 15-17 months, 19-21 months, and 23-25 months post treatment.
Tipo de estudio
Intervencionista
Inscripción (Actual)
72
Fase
- Fase 1
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
-
-
California
-
Stanford, California, Estados Unidos, 94305
- Stanford University, School of Medicine
-
-
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
No
Géneros elegibles para el estudio
Femenino
Descripción
Inclusion Criteria:
- Patients with gynecologic cancer who are undergoing vaginal brachytherapy as part of their treatment
- Patients cannot have previously received pelvic external beam radiation or brachytherapy. Patients may be enrolled while undergoing vaginal brachytherapy radiation treatment.
- Patients should have a life expectancy of at least 1 year
- No Eastern Cooperative Oncology Group (ECOG) or Karnofsky performance status requirements
- No organ and marrow function requirements
- Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
- Patients who have received prior pelvic external beam radiation or brachytherapy will be excluded
- No restrictions regarding use of other investigational agents
- No exclusion requirements due to co-morbid disease or intercurrent illness
- No investigational agent, so no exclusion requirements regarding history of allergic reactions attributed to compounds of similar chemical or biologic composition to investigational agent or device
- No exclusion criteria relating to concomitant medications
- No exclusion criteria for pregnant or nursing patients from participating in this study (Of note, pregnant patients will not be treated with vaginal brachytherapy, a requirement for enrolling on this study)
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
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Sin intervención: Arm I (no intervention)
Patients receive no additional reminders.
|
|
|
Experimental: Arm II (email survey)
Patients receive a reminder email survey every 2 weeks for 1 year after completing radiation.
|
Receive reminder email survey
Receive reminder email survey
|
|
Experimental: Arm III (email surveys and phone calls)
Patients receive a reminder email survey as in Arm I and 4 additional phone calls at 4-8 weeks, 3-5 months, 7-8 months, and 10-11 months during their first year of follow-up.
|
Receive reminder email survey
Receive reminder email survey
Receive reminder phone call
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Vaginal dilator adherence, measured by the average number of times per week patient uses a form of vaginal dilation
Periodo de tiempo: Up to 25 months after completing radiation
|
The vaginal dilator adherence measurements will analyzed in repeated measures model with treatment as a fixed effect and time as a within subject effect.
The overall mean of vaginal dilator adherence among the 3 groups will also be measured and compared.
The interaction between treatment and time will also be tested to see if the behavior over time is different depending on which treatment arm the patient is in.
|
Up to 25 months after completing radiation
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Vaginal canal length
Periodo de tiempo: Up to 25 months after completing radiation
|
The vaginal canal length will be measured using an extra small dilator and it will be calculated in centimeters.
The vaginal canal length measurements will be analyzed in a repeated measures model with treatment as a fixed effect and time as a within subject effect.
The interaction between treatment and time will also be tested to see if the behavior over time is different depending on which treatment arm the patient is in.
|
Up to 25 months after completing radiation
|
|
Incidence of adverse events (AE), reported by type and grade using the Common Terminology Criteria for Adverse Events version 4.03
Periodo de tiempo: Up to 30 days after the last dose of study treatment
|
The adverse events will be tabulated by type and grade at each follow up.
The total number of AE's as well as the number of AE's in each category: gynecologic, urinary and gastrointestinal will tabulated.
The test of proportion will be done per category of AE.
Since it is possible that the rates will be low, an exact test will be used to compare the rates.
|
Up to 30 days after the last dose of study treatment
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Elizabeth Kidd, Stanford University Hospitals and Clinics
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
1 de septiembre de 2014
Finalización primaria (Actual)
1 de enero de 2019
Finalización del estudio (Actual)
23 de octubre de 2020
Fechas de registro del estudio
Enviado por primera vez
6 de febrero de 2014
Primero enviado que cumplió con los criterios de control de calidad
6 de febrero de 2014
Publicado por primera vez (Estimar)
10 de febrero de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
17 de agosto de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
16 de agosto de 2021
Última verificación
1 de agosto de 2021
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRB-29074
- NCI-2013-02400 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
- GYN0005 (Otro identificador: OnCore)
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. .