The HEALS Project - Health Education and Active Living for Surviving Seniors (HEALS)
9 de noviembre de 2015 actualizado por: Anita Kinney, University of Utah
Biobehavioral Effects of Tai Chi Chih Among Elderly Female Cancer Survivors
Persons over age 65 years constitute a large and growing population of cancer survivors.
Available data indicate that both short- and long-term female breast cancer survivors report more limitations related to strength and mobility than women with cancers of other sites and women without a personal history of cancer.
Further, better mental health among breast cancer survivors has been shown to protect against physical decline and overall quality of life.
The combination of mental and physical interventions may result in substantial improvements in quality of life.
Tai Chi Chih (TCC), a form of mind-body exercise, is one such intervention.
TCC may be particularly suited toward elderly breast cancer survivors with impaired physical and/or mental functioning, yet despite its increasing popularity and benefits in healthy and diseased populations, its benefits have never been scientifically evaluated in this population.
The overarching goal of this study is to conduct preparatory work regarding the effects of TCC on quality of life and physical function that will underpin future definitive trials of TCC in elderly cancer survivors.
As part of this 12-week trial, participants will be randomized to a TCC or a health education control group (HEC).
Establishment of meaningful interventions that facilitate a more positive cancer survival experience in old age is an important issue; there are substantial public health and clinical benefits should a TC intervention be successful in this patient population.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
63
Fase
- Fase 2
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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Utah
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Salt lake City, Utah, Estados Unidos, 84112
- Huntsman Cancer Institute
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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
55 años a 90 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Femenino
Descripción
Inclusion Criteria:
- Age >/= 55 years and it has been three months or more (with the exception of hormone therapy) since completing treatment for breast or other solid tumor cancers (excluding lung, liver, pancreas and brain) and currently in remission.
- Living within 30 miles of Huntsman Cancer Institute and has access to transportation and is willing to travel to the study site per study protocol; Travels independently on public transportation or drives own car.
- Able to speak and read English fluently, and understand informed consent.
- Willing to: sign a medical record release form; to be randomized and willing to participate in classes and all baseline and follow-up appointments.
- Has some physical limitation as defined by a score of <72 in the Role Physical or <80 in the Physical Functioning sub-scales in the SF-12 screening questionnaire.
- Does not currently practice in a regular on-going meditative or relaxation technique.
- Does not currently engage in a regular, strenuous-intensity form of exercise for 30 min or more per day, 3 or more days per week.
Exclusion Criteria:
- Engaged in focused intense physical activity for 30 minutes or more a day for 3 or more days a week for the previous 6 months as per responses on the screening telephone call.
- Regular on-going practice with TC or other similar types of Complementary and Alternative Medicine in the past 6 months such as Qigong, meditation, relaxation, and yoga since these share some of the principles of TC.
- Inability to pass the Folstein Mini Mental Status Exam (score <23).
- Unable to drive or secure transportation to complete all aspects of the study.
- Health conditions (e.g. severe hearing loss, respiratory, cardiovascular, or neurological problems) that might interfere with the required intervention.
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 |
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Experimental: Tai Chi Chih
The Tai Chi Chih classes were 60 minutes sessions, held three times a week, over twelve weeks.
The classes were led by an instructor who was certified and licensed in the Tai Chi Chih form.
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Tai Chi Chih (TCC), a westernized and manualized form of the ancient TC Chuan, consists of a series of 20 simple, repetitive, non-strenuous movements that involve no physical contact and emphasize a soft, flowing continuity of motion.
This form of meditation through movement consists of a standardized protocol that emphasizes slow, fluid, continuous forms that integrate mental concentration, awareness, balance, shifting of body weight, gentle movement, imagery, muscle relaxation and breathing control.
TCC was developed for use with elderly persons.
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Comparador activo: Health Education Classes
Health Education classes were 60 minute sessions that occurred three times a week, over twelve weeks.
These classes were taught by specialists in the class topic and focused on topics related to aging (e.g., sleep quality, nutrition, pain, etc.).
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The Health Education classes serve as an attention control group, are led by gerontology specialists, physicians, and other health professionals, and focus on topics that are relevant to elderly cancer survivors.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Retention Rates and Class Attendance
Periodo de tiempo: 13 weeks
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The 12-week intervention assessed retention in the study (percentage of how many participants remained enrolled the entire intervention), class attendance (percentage out of possible classes)
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13 weeks
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Satisfaction With the Randomized Controlled Trial
Periodo de tiempo: 13 weeks
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The 12-week intervention assessed satisfaction with intervention(0=strongly agree to 4=strongly disagree).
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13 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Health-Related Quality of Life (Short Form (SF)-36v1)
Periodo de tiempo: 13 weeks
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SF-36v1 Health Survey assesses quality of life and produces mental and physical component summary scores, with a score range of 0 to 100.
Higher scores indicate better quality of life.
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13 weeks
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Perceived Stress Scale
Periodo de tiempo: 13 weeks
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The 10-item perceived stress scale produces a summation score.
Scores can range from 0 to 40, with higher scores indicating more stress.
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13 weeks
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Impact of Events Scale
Periodo de tiempo: 13-weeks
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The Impact of Event Scale assesses cancer-specific distress.
Each item is scored 0 (not at all), 1 (rarely), 3 (sometimes)or 5 (often), with the higher scores reflecting more stressful impact.
It has a total score and two subscales (avoidance & intrusion).
The two subscales are scored by summing their corresponding items and the total score is the sum of two subscales.
The scores for the intrusive subscale range from 0 to 35, and scores for the avoidance subscale range from 0 to 40.
The Total Score ranges from 0-75, with higher scores reflecting more stressful impact.
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13-weeks
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Pittsburgh Sleep Quality Index
Periodo de tiempo: 13-weeks
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The Pittsburgh Sleep Quality produces a global score.
The range is 0 to 21, higher scores indicate worse sleep quality.
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13-weeks
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Five-Facet Mindfulness Questionnaire
Periodo de tiempo: 13-weeks
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The Five-Facet Mindfulness questionnaire produces a total score and five facet subscales (observing, describing, acting with awareness, nonjudging, & nonreactivity).
These are summation scores, and the scores range from 8 to 40 (except for the nonreactivity facet which ranges from 7 to 35).
Higher scores indicate more mindfulness.
The Total Score ranges from 39-195, with higher scores indicating more mindfulness.
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13-weeks
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Blood Pressure
Periodo de tiempo: 13-weeks
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Systolic and Diastolic blood pressure were assessed at the study's physical assessment sessions.
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13-weeks
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Cortisol Area-Under-Curve (AUC)
Periodo de tiempo: 13-weeks
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Five saliva samples (awakening, 30 minutes after awakening, noon, 5pm, & 10pm) were collected on a weekend day at one week after class completion.
Cortisol was measured in nmol/L.
Cortisol AUC was calculated using the five timepoints with the trapezoid rule.
The groups were compared at post-intervention on their log transformed cortisol AUC controlling for baseline cortisol and reported as adjusted means.
Four participants with high cortisol profiles across the five collection times (with suspected contamination from gum bleeding) and participants whose collection time was beyond a one hour window were excluded.
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13-weeks
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Inflammatory Cytokines
Periodo de tiempo: 13-weeks
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Fasting blood samples were collected in the morning for inflammatory cytokines.
Prior to blood draws, we ensured that participants did not experience illness or fever at the time of the blood draw.
The assayed cytokines included pro-inflammatory cytokines interleukin(IL)-12, IL-6, tumor necrosis factor (TNF)-α, and anti-inflammatory cytokines IL-10 and IL-4.
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13-weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Anita Kinney, Huntsman Cancer Institute
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.
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 diciembre de 2009
Finalización primaria (Actual)
1 de septiembre de 2011
Finalización del estudio (Actual)
1 de noviembre de 2011
Fechas de registro del estudio
Enviado por primera vez
18 de febrero de 2011
Primero enviado que cumplió con los criterios de control de calidad
24 de febrero de 2011
Publicado por primera vez (Estimar)
28 de febrero de 2011
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
14 de diciembre de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
9 de noviembre de 2015
Última verificación
1 de noviembre de 2015
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 34851
- R21 CA135250-2 (Otro número de subvención/financiamiento: NCI)
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. .