Mindfulness Intervention in Reducing Anxiety in Patients Who Have Been Treated for Gynecologic Cancer
13 de noviembre de 2019 actualizado por: University of Wisconsin, Madison
Mindfulness-Based Interventions in Patients Treated for Gynecologic Cancer - Impact on Patient Reported Outcomes and Immunologic Correlates
This pilot clinical trial studies how well a mindfulness-based stress reduction (MBSR) intervention works in reducing anxiety in patients who have undergone treatment for gynecologic cancer but no longer have any sign of disease.
Gynecologic cancer is cancer of the female reproductive tract, which includes the cervix, endometrium, fallopian tubes, ovaries, uterus, and vagina.
Side effects from treatment for these cancers may include anxiety, fatigue, depression, and sexual function changes.
Mindfulness training uses meditation and yoga to help patients focus on breathing, bodily sensations, and mental awareness.
This may help decrease patients' stress and anxiety and improve their quality of life, and may also help their immune system.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Patients are randomized to 1 of 2 Arms.
ARM I (INTERVENTION): Patients undergo an 8-week MBSR course, comprising weekly 2.5 hour classes and one 6-hour Saturday class at week 6 or 7. The MBSR program involves instruction in mindfulness meditation and yoga, and gives homework assignments involving practicing the well-being techniques taught in class. Patients are required to record and report time spent on home practice in a journal daily, and receive a weekly reminder to report their home practice.
ARM II (WAIT-LIST CONTROL): Patients do not participate in the intervention, but are given the option to be placed on a waitlist for the MBSR course and may complete it within 6 months after the final study visit.
After completion of study, patients are followed up at 8 weeks (at completion of study) and 5 months (3 months from study completion).
Tipo de estudio
Intervencionista
Inscripción (Actual)
38
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
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Wisconsin
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Madison, Wisconsin, Estados Unidos, 53705
- University of Wisconsin Carbone Cancer Center
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-
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:
- Diagnosis of any invasive gynecologic cancer without evidence of disease.
- Gynecologic cancer treatment (e.g., surgery, chemotherapy, radiation therapy) was completed within 5 years prior to date of enrollment.
- Able to speak, read and write English
- ECOG Performance Status between 0 and 3
- Subjects must have a phone.
- Experiencing 2 or more of the following symptoms felt to be associated (per the patient) with gynecologic cancer or previous gynecologic cancer treatment: anxiety (worry or feeling stressed), cognitive impairment (difficulty concentrating, focusing, memory loss), depression, existential/spiritual distress (hopelessness, lack of meaning in life, lack of peace), fatigue, pain, and sexual dysfunction. These symptoms may be new or worsened since cancer diagnosis. Both symptoms fomr this list must have been present one week prior to eligibility assessment, with worst severity rating greater than or equal to 3 (0-10 scale) for at least 1 of the 2 symptoms
- Expected to continue cancer care at UWCCC for the duration of the study.
Exclusion Criteria:
- Undergone cancer treatment (excluding hormonal therapy or biological maintenance therapy) in the 4 weeks prior to enrollment
- Expected to require cancer treatment, other than biologic or hormonal maintenance therapy, during the course of the study
- Any other cancer present within the last 5 years (other than gynecologic cancer under study and non-melanoma skin cancer)
- Practicing mindfulness meditation for an average of more than 1 hour/week or have taken mindfulness training in the past
- Documented history of Alzheimer's disease, dementia, or other neurologic deficit that could impact decision-making
- Prisoner or incarcerated
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: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Arm I (MBSR intervention)
Patients undergo an 8-week MBSR course, comprising weekly 2.5 hour classes and one 6-hour Saturday class at week 6 or 7.
The MBSR program involves instruction in mindfulness meditation and yoga, and gives homework assignments involving practicing the well-being techniques taught in class.
Patients are required to record and report time spent on home practice in a journal daily, and receive a weekly reminder to report their home practice.
|
The Mindfulness-Based Stress Reduction program involves instruction in mindfulness meditation and yoga.
Otros nombres:
|
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Sin intervención: Arm II (control)
Patients do not participate in the intervention, but are given the option to be placed on a waitlist for the MBSR course and may complete it within 6 months after the final study visit.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in anxiety
Periodo de tiempo: Baseline to up to 5 months
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Measured by the 8-item anxiety subscale of the PROMIS scale.
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Baseline to up to 5 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in depression
Periodo de tiempo: Baseline to up to 5 months
|
Measured by PROMIS subscale for depression.
|
Baseline to up to 5 months
|
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Change in fatigue
Periodo de tiempo: Baseline to up to 5 months
|
Measured by PROMIS subscale for fatigue.
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Baseline to up to 5 months
|
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Change in sleep disturbance
Periodo de tiempo: Baseline to up to 5 months
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Measured by PROMIS subscale for sleep disturbance.
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Baseline to up to 5 months
|
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Change in sexual function
Periodo de tiempo: Baseline to up to 5 months
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Measured by Female Sexual Function Profile and Global Satisfaction with Sex Life questionnaire.
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Baseline to up to 5 months
|
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Change in existential/spiritual distress
Periodo de tiempo: Baseline to up to 5 months
|
measured by Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being Scale (FACIT-SP-12 version 4)
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Baseline to up to 5 months
|
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Change in cognitive function
Periodo de tiempo: Baseline to up to 5 months
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Measured by the NIH Toolbox Assessments
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Baseline to up to 5 months
|
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Change in cortisol levels
Periodo de tiempo: Baseline to up to 5 months
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The biobehavioral link between MBSR intervention-related Quality of Life changes and immune cell function will be explored.
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Baseline to up to 5 months
|
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Change in levels of pro-inflammatory cytokines
Periodo de tiempo: Baseline to up to 5 months
|
The biobehavioral link between MBSR intervention-related Quality of Life changes and immune cell function will be explored.
|
Baseline to up to 5 months
|
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Change in immune cell phenotypes
Periodo de tiempo: Baseline to up to 5 months
|
The biobehavioral link between MBSR intervention-related Quality of Life changes and immune cell function will be explored.
|
Baseline to up to 5 months
|
|
Change in NK cell function
Periodo de tiempo: Baseline to up to 5 months
|
The biobehavioral link between MBSR intervention-related Quality of Life changes and immune cell function will be explored.
|
Baseline to up to 5 months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Ryan Spencer, University of Wisconsin, Madison
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Enlaces Útiles
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)
18 de noviembre de 2015
Finalización primaria (Actual)
20 de junio de 2019
Finalización del estudio (Actual)
20 de junio de 2019
Fechas de registro del estudio
Enviado por primera vez
4 de agosto de 2015
Primero enviado que cumplió con los criterios de control de calidad
4 de agosto de 2015
Publicado por primera vez (Estimar)
7 de agosto de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
15 de noviembre de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
13 de noviembre de 2019
Última verificación
1 de julio de 2019
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- UW15000
- A532820 (Otro identificador: UW Madison)
- 2015-0549 (Otro identificador: Institutional Review Board)
- SMPH\OBSTET & GYNECOL\OB-GYN (Otro identificador: UW Madison)
- NCI-2015-01263 (Identificador de registro: NCI Trial ID)
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