Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210-1240, United States
NCT Number: NCT00486525
RATIONALE: Yoga may improve inflammation, fatigue, and depression in female breast cancer survivors.
PURPOSE: This randomized clinical trial is studying how well Hatha yoga works in improving physical activity, inflammation, fatigue, and distress in female breast cancer survivors.
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Notify Me21 year and older
Female
Interventional
Not applicable
Columbus, Ohio, 43210-1240, United States
OBJECTIVES:
Primary
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Inclusion criteria
Exclusion criteria
PRIOR CONCURRENT THERAPY:
Patients will undergo yoga therapy
Other names: Yoga
Time frame: Immediately post-treatment and 3 months post-treatment
log-transformed Lipopolysaccharide (LPS) stimulated Tumor Necrosis Factor-alpha (TNF-alpha)
Time frame: Immediately post-treatment and 3 months post-treatment
log-transformed Lipopolysaccharide (LPS) stimulated Interleukin-6 (IL-6)
Time frame: Immediately post-treatment and 3 months post-treatment
log-transformed Lipopolysaccharide (LPS) stimulated Interleukin-1 beta (IL-1b)
Time frame: Immediately post-treatment and 3 months post-treatment
The 30-item Multidimensional Fatigue Symptom Inventory-Short form (MFSI-SF) assesses behavioral, cognitive, physical, and affective expressions of fatigue.
Items are rated on a 5-point scale indicating how true each statement was for the respondent during the last week (0=not at all; 4=extremely). The total score represents the sum of the subscales measuring general, physical, emotional, and mental fatigue, minus the vigor scale, providing a possible range of scores from -24 to 96, with higher scores indicating greater fatigue.
Time frame: Immediately post-treatment and 3 months post-treatment
The SF-36's (RAND Health Survey) energy/fatigue (vitality) scale focuses on the frequency of feelings of fatigue over the last month.
Standardized scores on the RAND SF-36 vigor/vitality scale range from 0-100, with higher scores indicating less fatigue.
Time frame: Immediately post-treatment and 3 months post-treatment
The Center for Epidemiological Studies Depression Scale (CES-D) is a self-report scale designed to measure current symptoms of depression rated on a four-point likert scale.
Scores range from 0-60, with higher scores indicating a higher frequency of depressive symptoms.
Ohio State University Comprehensive Cancer Center
Other
Breast Cancer Survivors: Physical Activity, Inflammation, Fatigue, and Distress
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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