Breast Cancer Survivors: Physical Activity, Inflammation, Fatigue, and Distress
Yoga Therapy
Carcinome du sein in situ+13
+ Maladies du sein
+ Néoplasmes du sein
Soins de support
Résumé
Date de début de l'étude : 1 août 2007
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.200 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Soins de support
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Femme
Le sexe biologique des participants éligibles à s'inscrire.À partir de 21 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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 l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Un seul groupe d'intervention est désigné dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalObjectifs de l'étude
Objectifs principaux
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus, United StatesOuvrir Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center dans Google Maps