Breast Cancer Survivors: Physical Activity, Inflammation, Fatigue, and Distress
Yoga Therapy
Breast Carcinoma In Situ+16
+ Behavior
+ Behavioral Symptoms
Supportive Care Study
Summary
Study start date: August 1, 2007
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.200 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Supportive Care Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Over 21 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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)
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus, United StatesOpen Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center in Google Maps