Prerrehabilitación para pacientes femeninas sometidas a radioterapia pélvica
The purpose of this study is to examine the feasibility of adding pre-rehabilitation pelvic health physical therapy to standard of care radiation therapy treatment plan for female patients who have been diagnosed with cervical, vaginal, vulvar, uterine, or anal cancer and are a candidate for curative pelvic radiation with external beam. Participants will receive education on using a vaginal dilator for use during treatment and complete questionnaires looking at pain and sexual function.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Because of the increasing survivorship rate, there is a need for research addressing the post-treatment side effects of pelvic pain and dyspareunia, due to the significant impact these side effects have on patients' quality of life. Current best practice from trained pelvic health physical therapists for addressing dyspareunia and pelvic pain due to vaginal stenosis after radiation therapy, is vaginal dilation. Vaginal dilators are cone shaped durable medical equipment that are inserted into the vagina with lubricant, to assist in patency of the vaginal canal and stretching of the pelvic floor muscles.
The primary objective of this pilot clinical trial is to assess the feasibility of implementing a collaborative, coordinated, and multidisciplinary initiative between radiation oncology and pelvic health physical therapy to answer the following questions: 1) What are the barriers and facilitators to the implementation of a pre-rehabilitation service for gynecological and female anal cancer patients undergoing pelvic radiation and 2) What is the potential clinical value of adding pre-rehabilitative pelvic health services, with an emphasis on vaginal dilator education and use, to the gynecological and female anal cancer radiation setting, in collaboration with radiation oncology staff, as a means of reducing pelvic pain and dyspareunia?
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Namita Agrawal, MD
- Número de teléfono: (317)944-2524
- Correo electrónico: agrawaln@indiana.edu
Copia de seguridad de contactos de estudio
- Nombre: Sarah Dutkevich, RN
- Número de teléfono: (317)278-5618
- Correo electrónico: sdutkevi@iu.edu
Ubicaciones de estudio
-
-
Indiana
-
Avon, Indiana, Estados Unidos, 46123
- Reclutamiento
- IU Health West
-
Contacto:
- Nikki Barrow
- Número de teléfono: 317-944-1242
- Correo electrónico: nrbarrow@iu.edu
-
Carmel, Indiana, Estados Unidos, 46032
- Reclutamiento
- IU Health Schwarz Cancer Center
-
Contacto:
- John Spittler
- Número de teléfono: 3172740771
- Correo electrónico: ajspittl@iu.edu
-
Indianapolis, Indiana, Estados Unidos, 46202
- Reclutamiento
- Indiana University Melvin and Bren Simon Comprehensive Cancer Center
-
Contacto:
- Sarah Dutkevitch, RN
- Número de teléfono: 317-278-5618
- Correo electrónico: sdutkevi@iu.edu
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Female
- ≥ 18 years old at the time of informed consent
- Ability to provide written informed consent and HIPAA authorization
- Primary diagnosis of cervical, vaginal, vulvar, uterine, or anal cancer
- Candidate for curative pelvic radiation with external beam, with or without brachytherapy, per radiation oncologist's discretion
Notes:
- Can have prior and/or current modalities of treatment to address diagnosis including surgery and chemotherapy
- Can receive radiation at any facility provided patient is able to perform Physical Therapy visits at IUH North/Schwarz Cancer Center
Exclusion Criteria:
- Major medical illnesses or psychiatric impairments, which in the investigator's opinion will prevent administration or completion of the protocol therapy and/or interfere with follow-up.
- Not a candidate for curative radiation therapy per radiation oncologist's discretion
- Prior radiation therapy to the pelvis
- Women who are pregnant or nursing
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Evaluación e intervención de la salud pélvica.
|
Female Sexual Function Index (FSFI) and VAS Pain Scale Questionnaires, Physical Therapy Evaluation including Pelvic Floor Muscle Examination, Dilator Education Patient Adherence to Vaginal Dilation Questionnaire |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Feasability of implementation of pre-rehabilitation to radiotherapy
Periodo de tiempo: Baseline
|
Recording the number of eligible patients for protocol that decline enrollment. The reason(s) for forgoing protocol intervention will be documented. |
Baseline
|
|
Feasability of implementation of pre-rehabilitation to radiotherapy
Periodo de tiempo: Baseline
|
The number of eligible patients that were not identified for protocol enrollment will be recorded and potential gaps in the screening process will be analyzed. |
Baseline
|
|
Feasability of implementation of pre-rehabilitation to radiotherapy
Periodo de tiempo: Baseline
|
The number of eligible patients identified, but not screened, for eligibility or not consented if eligible will be recorded. |
Baseline
|
|
Feasability of implementation of pre-rehabilitation to radiotherapy
Periodo de tiempo: Baseline
|
The duration of time from initial clinical presentation to being offered information of clinical study will be recorded. |
Baseline
|
|
Feasability of implementation of pre-rehabilitation to radiotherapy
Periodo de tiempo: Baseline to 6 weeks
|
The duration of time from enrollment on clinical study to being seen by physical therapy will be recorded. |
Baseline to 6 weeks
|
|
Feasability of implementation of pre-rehabilitation to radiotherapy
Periodo de tiempo: Baseline to 4 months
|
The number of Female Sexual Function Index questionnaires will be recorded as completed, incomplete or not attempted. Reasons for submitting incomplete questionnaires or not submitting a questionnaire will be recorded. |
Baseline to 4 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Average score on the Visual Pain Rating Scale.
Periodo de tiempo: 4 weeks, 6 weeks, 8 weeks, 12 weeks, and 16 weeks post radiation
|
Visual Analogue Pain Rating Scale 0-10 |
4 weeks, 6 weeks, 8 weeks, 12 weeks, and 16 weeks post radiation
|
|
Evaluate female sexual function based on questionnaire responses
Periodo de tiempo: 4 weeks, 6 weeks, 8 weeks, 12 weeks, and 16 weeks post radiation
|
Female Sexual Function Index questionnaires (Likert scale) |
4 weeks, 6 weeks, 8 weeks, 12 weeks, and 16 weeks post radiation
|
|
Percentage of adherence to dilator use
Periodo de tiempo: 4 weeks, 6 weeks, 8 weeks, 12 weeks, and 16 weeks post radiation
|
Self-reported dilator adherence |
4 weeks, 6 weeks, 8 weeks, 12 weeks, and 16 weeks post radiation
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Namita Agrawal, MD, Indiana University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
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
- Enfermedades urogenitales
- Enfermedades Genitales
- Dolor
- Manifestaciones neurológicas
- Desordenes mentales
- Heridas y Lesiones
- Enfermedades Genitales Masculinas
- Enfermedades urogenitales masculinas
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Enfermedades Genitales Femeninas
- Disfunciones Sexuales Psicológicas
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Dolor pélvico
- Dispareunia
- Disfunción Sexual Fisiológica
- Lesiones por radiación
Otros números de identificación del estudio
- CTO-IUSCCC-0772
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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