Exercise Oncology Clinic Pilot Feasibility Trial
10 de agosto de 2026 actualizado por: Jess S. Gorzelitz
Pilot Feasibility Trial for the Exercise Oncology Clinic in Breast and Gynecologic Oncology Patients
The purpose of this pilot study is to test a supervised exercise program for adults with a history of breast or gynecologic cancer to see if it is safe, helpful, and easy to take part in.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
This pilot study will enroll up to 30 adult cancer patients to participate in a structured exercise oncology clinic to evaluate and refine clinical procedures for individualized exercise assessment and prescription.
The study is designed to generate preliminary data on the feasibility, acceptability, and safety of implementing a supervised exercise program integrated into oncology care.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
30
Fase
- No aplica
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.
Estudio Contacto
- Nombre: Jess Gorzelitz, PhD, MS
- Número de teléfono: (319) 467-0849
- Correo electrónico: jessica-gorzelitz@uiowa.edu
Ubicaciones de estudio
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Iowa
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Iowa City, Iowa, Estados Unidos, 52242
- Reclutamiento
- University of Iowa Health Care
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Contacto:
- Jess Gorzelitz, PhD, MS
- Número de teléfono: (319) 467-0849
- Correo electrónico: jess-gorzelitz@uiowa.edu
-
-
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
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Age ≥18 years
- Confirmed diagnosis of breast or gynecologic cancer (any stage)
- Willingness to participate in the exercise oncology program and associated research procedures Ability to provide informed consent
- Clearance to participate in exercise as determined by completion of the Physical Activity Readiness Questionnaire Plus (PAR-Q+) and any additional clinical screening as needed
Exclusion Criteria:
- Presence of absolute contraindications to exercise (e.g., unstable cardiovascular disease, acute illness, or other conditions that preclude safe participation in physical activity)
- Determination by a referring or treating healthcare provider that the patient is not appropriate for exercise participation at the time of screening
- Inability to complete required screening procedures, including the PAR-Q+
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: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Supervised, Personalized Exercise Program
The clinic will conduct comprehensive patient assessments, develop personalized exercise programs, and monitor progress through fitness evaluations and wearable devices.
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Sessions will include both resistance (strength) training and aerobic exercise, delivered under the guidance of trained personnel to ensure appropriate technique, progression, and safety.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Recruitment rate calculated as the number of participants enrolled divided by the number approached or referred over the study period.
Periodo de tiempo: Recruitment period which will start at day 1 through two months
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Recruitment rate will be reported as a proportion (percentage) each month
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Recruitment period which will start at day 1 through two months
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Retention rate defined as the proportion of enrolled participants who complete the 12-week intervention and post-intervention assessment.
Periodo de tiempo: Pre-assessment/treatment initiation through post-intervention assessment, approximately 14 weeks
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Retention rate will be reported as a proportion (percentage)
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Pre-assessment/treatment initiation through post-intervention assessment, approximately 14 weeks
|
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Adherence to exercise sessions calculated as the number of completed supervised exercise sessions divided by the number of prescribed sessions.
Periodo de tiempo: Pre-assessment/treatment initiation through post-intervention assessment, approximately 14 weeks
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Summarized as mean adherence (%) and proportion meeting predefined adherence thresholds (e.g., >70%;>80%).
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Pre-assessment/treatment initiation through post-intervention assessment, approximately 14 weeks
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Completeness of functional testing procedures defined as the proportion of participants with complete baseline and follow-up fitness assessments.
Periodo de tiempo: Pre-assessment/treatment initiation through post-intervention assessment, approximately 14 weeks
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All feasibility outcomes will be summarized using descriptive statistics (means, standard deviations, medians, ranges, and proportions with 95% confidence intervals where appropriate).
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Pre-assessment/treatment initiation through post-intervention assessment, approximately 14 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Participant satisfaction (e.g., Likert-scale survey items) summarized as means and distributions across response categories.
Periodo de tiempo: Pre-assessment/treatment initiation through post-intervention assessment, approximately 14 weeks
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Satisfaction survey responses summarized as means and distributions across response categories.
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Pre-assessment/treatment initiation through post-intervention assessment, approximately 14 weeks
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Participant perceived burden (e.g., time, effort, difficulty) reported descriptively and categorized (low/moderate/high burden)
Periodo de tiempo: Pre-assessment/treatment initiation through post-intervention assessment, approximately 14 weeks
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Perceived burden survey responses reported descriptively and categorized (low/moderate/high burden)
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Pre-assessment/treatment initiation through post-intervention assessment, approximately 14 weeks
|
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Willingness to participate or continue exercise programming reported as proportions (%) endorsing continued participation.
Periodo de tiempo: Pre-assessment/treatment initiation through post-intervention assessment, approximately 14 weeks
|
Proportion of participant endorsement of exercising or continuing exercise programming.
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Pre-assessment/treatment initiation through post-intervention assessment, approximately 14 weeks
|
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Participant qualitative feedback (if collected) summarized using brief thematic categorization to identify common facilitators and barriers.
Periodo de tiempo: Pre-assessment/treatment initiation through post-intervention assessment, approximately 14 weeks
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Participant qualitative feedback summarized by brief theme categorization,
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Pre-assessment/treatment initiation through post-intervention assessment, approximately 14 weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Jess Gorzelitz, PhD, MS, University of Iowa
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)
3 de agosto de 2026
Finalización primaria (Estimado)
15 de diciembre de 2026
Finalización del estudio (Estimado)
15 de abril de 2027
Fechas de registro del estudio
Enviado por primera vez
31 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
10 de agosto de 2026
Publicado por primera vez (Actual)
14 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
14 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
10 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 202508370
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. .