Breast Cancer Survivors: Physical Activity, Inflammation, Fatigue, and Distress
Yoga Therapy
Carcinoma+12
+ Carcinoma in situ
+ Enfermedades de la Mama
Estudio de Cuidados de Apoyo
Resumen
Fecha de inicio: 1 de agosto de 2007
Fecha en la que se inscribió al primer participante.OBJECTIVES: Primary * To determine if the yoga intervention will decrease inflammation, fatigue, and depressive symptoms relative to the waiting-list controls in women who are stage 0-IIIa breast cancer survivors. OUTLINE: Patients are stratified according to stage of cancer (stage 0 vs stage I vs stage II and stage IIIA) and prior radiation therapy (yes vs no). Patients are randomized to 1 of 2 intervention arms. * Arm I (waiting-list control): Patients are encouraged to perform usual activities, but asked to refrain from any yoga practice or other related activities. After a six-month observation period, patients undergo yoga intervention as described in arm II . * Arm II (yoga intervention): Patients participate in a Hatha yoga intervention session comprising body postures and breath control techniques for 1.5 hours twice a week for 12 weeks. Patients are encouraged to practice Hatha yoga at home. Patients complete daily diaries on home Hatha yoga practices and submit them at each session.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 200 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Cuidados de Apoyo
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Mujer
Sexo biológico de los participantes elegibles para inscribirse.A partir de 21 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
DISEASE CHARACTERISTICS: * Stage 0-IIIA breast cancer survivor * Completed cancer treatment within the past 36 months (except for tamoxifen/aromatase inhibitors) * At least 2 months since prior surgery, adjuvant therapy, or radiotherapy, whichever occurred last * Women who are not currently practicing yoga and have not participated in any of the following activities: * Meditation, tai chi, or related activities * Yoga or tai chi within the past 6 months * Had classes for or practiced yoga for more than 3 months * Women who typically engage in a total of 5 or more hours of vigorous physical activity per week are not eligible * No inflammatory breast cancer PATIENT CHARACTERISTICS: Inclusion criteria: * Hemoglobin ≥ 10 g/dL (patients with a hemoglobin of \< 10 g/dL may be retested in 6 weeks after treatment of anemia and allowed to participate in study if blood counts recovered) * Physically able to fully participate in yoga intervention Exclusion criteria: * Inability to comfortably get up and down from the floor 2-3 times in a session * Breathing problems requiring use of oxygen * Problems walking without a cane or walker assistance * Prior knee or hip replacement with limited movement in the joint * Inability to comfortably lie on the stomach * Alcohol, or drug abuse * Diagnosis of any of the following conditions: * Diabetes * Chronic obstructive pulmonary disease * Uncontrolled hypertension * Evidence of liver or kidney failure * Symptomatic ischemic heart disease * Significant visual or auditory problems * Mental disorder or cognitive impairment * Notable serious cardiovascular history (e.g., prior life-threatening abnormal heart rhythms) * Other medical conditions involving the immune system such as autoimmune and/or inflammatory diseases including rheumatoid arthritis and ulcerative colitis * History of breast or any other cancer, except basal or squamous cell skin cancer PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No regular use of medications with major immunological consequences (e.g., steroids)
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Un solo grupo de intervención está designado en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalObjetivos del Estudio
Objetivos Primarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus, United StatesAbrir Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center en Google Maps