This pilot clinical trial studies Hatha yoga in reducing physical and emotional problems in breast cancer survivors with or without stage II-III lymphedema. Yoga practices may benefit breast cancer survivors with lymphedema as they directly support lymph transport (postures, breathing, relaxation) and emotional well-being (relaxation, meditation).
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02923037.
PRIMARY OBJECTIVES:
I. To identify and document required modifications for a safe and feasible practice.
II. To obtain recruitment estimates and determine barriers to recruitment (acceptability).
III. To evaluate implementation fidelity (adherence and competence) and barriers to implementation fidelity.
IV. To establish safety.
V. To assess satisfaction.
VI. To determine the preliminary efficacy of a modified yoga program for lymphedema in breast cancer survivors (BCS), and associated physical and psychological symptoms/symptom burden, and overall health status.
SECONDARY OBJECTIVES:
I. To evaluate potential clinical signals for change in physical and psychological symptoms/symptom burden and overall health status subsequent to undergoing the yoga program.
OUTLINE:
Patients undergo an initial yoga evaluation for 60 minutes. Patients then undergo their first guided yoga practice session for 30-60 minutes and subsequent guided yoga sessions for 30-90 minutes 3 times a week for 4 weeks, and twice a week for an additional 4 weeks. Patients are also encouraged to complete home yoga practice for 30 to 90 minutes every day for 8 weeks.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationVanderbilt University/Ingram Cancer Center
Principal InvestigatorSheila H. Ridner
