- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02442635
Yoga During Chemotherapy Study
12 de noviembre de 2019 actualizado por: University of California, San Francisco
Developing a Yoga Intervention During Cancer Chemotherapy
This proposal aims to expand non-pharmacologic options for the control of symptoms during chemotherapy using yoga practices.
It is particularly focused on sleep disturbance with a secondary focus on fatigue.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Sleep disturbance is among the most common symptoms experienced by cancer patients, occurs in up to 80% of patients during chemotherapy, and results in serious impairments in quality of life.
Although pharmacologic therapies improve sleep disturbance, they have numerous side effects, problems with tolerance and dependence, and are not well studied in oncology patients.
While non-pharmacologic therapies may decrease sleep disturbance, the current level of evidence on their efficacy is insufficient.
Fatigue occurs in up to 95% of those receiving chemotherapy, and results in major impairments in functioning and quality of life.
Despite its significance, few effective treatments currently exist for fatigue.
Prior studies suggest that yoga may be helpful for sleep disturbance and fatigue, but these studies have limitations.
An important challenge in yoga research is that it is typically a multi-modality practice that can include physical postures, breathing practices, and/or meditation components.
Prior studies have not adequately addressed the effects of individual components.
Therefore, key questions remain unanswered about the most effective elements of yoga; how to best combine them for particular problems such as chemotherapy symptoms; and optimal dosing.
The current study will address these gaps in the literature and perform key developmental steps to prepare for a large randomized, controlled trial (RCT).
It builds on preliminary work in which yoga breathing practices during chemotherapy were found to improve sleep disturbance, showed trends toward improvements in fatigue, and were feasible to implement in patients undergoing chemotherapy.
Using a mixed-methods approach to evaluate each intervention component, the investigators will pursue three closely interlinked steps in cancer patients receiving chemotherapy.
In Aim 1 (n=10), the investigators will manualize an individualized approach to the yoga breathing intervention and iteratively refine it to insure feasibility and acceptability.
In Aim 2 (n=20), the investigators will manualize a yoga posture intervention, evaluating both restorative/static poses and flowing poses, and perform iterative refinement to test feasibility and acceptability.
In Aim 3 (n=70), the investigators will assess the final multi-modality yoga intervention to select final intervention elements and delivery methods for testing in a planned future RCT.
This proposal will help to improve the treatment of debilitating cancer associated symptoms and advance approaches to developing therapeutic yoga intervention trials.
Tipo de estudio
Intervencionista
Inscripción (Actual)
73
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.
Ubicaciones de estudio
-
-
California
-
San Francisco, California, Estados Unidos, 94110
- UCSF
-
-
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
Todos
Descripción
Inclusion Criteria:
- Age 18 and older
- Have a Karnofsky Performance Status Score of 60 or above
- Diagnosed with any cancer except acute leukemia
- Self-reported poor quality of sleep
- Receiving Chemotherapy
- Able to read, write, and understand English
- Ability to give informed consent
Exclusion Criteria:
- Diagnosed with brain metastasis
- Diagnosed with severe Chronic Obstructive Pulmonary Disease (COPD) or emphysema
- Have New York Heart Association class II or greater congestive heart failure
- Requiring chronic home oxygen therapy
- Diagnosed with a sleep disorder (e.g., sleep apnea or narcolepsy)
- Have received more than 3 prior chemotherapy regimens
- Receiving radiation therapy
- Has a less than 6 month life expectancy
- Regular yoga practice within the last 2 months
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 |
|---|---|
|
Experimental: Condition 1
Yoga Breathing
|
Yoga breathing and postures; After this initial 3 arm experiment, yoga breathing and postures will be studied in combination.
|
|
Experimental: Condition 2
Static Yoga
|
Yoga breathing and postures; After this initial 3 arm experiment, yoga breathing and postures will be studied in combination.
|
|
Experimental: Condition 3
Flowing Yoga
|
Yoga breathing and postures; After this initial 3 arm experiment, yoga breathing and postures will be studied in combination.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Sleep Disturbance as measured by the General Sleep Disturbance Scale
Periodo de tiempo: 6 weeks
|
6 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Fatigue as measured by the Lee Fatigue Scale
Periodo de tiempo: 6 weeks
|
6 weeks
|
Otras medidas de resultado
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Quality of Life as measured by the Multidimensional Quality of Life Scale--Cancer
Periodo de tiempo: 6 weeks
|
6 weeks
|
|
Depressive Symptoms as measured by the CES-D
Periodo de tiempo: 6 weeks
|
6 weeks
|
|
Anxiety as measured by the Spielberger State Anxiety Inventory
Periodo de tiempo: 6 weeks
|
6 weeks
|
|
Pain as measured by the modified Brief Pain Inventory
Periodo de tiempo: 6 weeks
|
6 weeks
|
|
Hot Flashes as measured by the Hot Flash Related Daily Interference Scale
Periodo de tiempo: 6 weeks
|
6 weeks
|
|
Mindfulness as measured by the Five Facet Mindfulness Questionnaire
Periodo de tiempo: 6 weeks
|
6 weeks
|
|
Body Awareness as measured by the Multidimensional Assessment of Interoceptive Awareness
Periodo de tiempo: 6 weeks
|
6 weeks
|
|
Coping and Self Efficacy as measured by the Coping and Self Efficacy Scale
Periodo de tiempo: 6 weeks
|
6 weeks
|
|
Social Support as measured by single items on social support
Periodo de tiempo: 6 weeks
|
6 weeks
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Anand Dhruva, MD, University of California, San Francisco
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 mayo de 2015
Finalización primaria (Actual)
1 de octubre de 2019
Finalización del estudio (Actual)
1 de octubre de 2019
Fechas de registro del estudio
Enviado por primera vez
30 de abril de 2015
Primero enviado que cumplió con los criterios de control de calidad
8 de mayo de 2015
Publicado por primera vez (Estimar)
13 de mayo de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
14 de noviembre de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
12 de noviembre de 2019
Última verificación
1 de noviembre de 2019
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 15-15691
- R34AT007935 (Subvención/contrato del NIH de EE. UU.)
- 15991 (Otro identificador: University of California, San Francisco)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
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