Breast Carcinoma, Lymphedema
Conditions
Brief summary
This pilot clinical trial studies Hatha yoga in reducing physical and emotional problems in breast cancer survivors with 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).
Detailed description
PRIMARY OBJECTIVES: I. To determine the feasibility of a modified yoga program for breast cancer survivors (BCS) with lymphedema. II. To identify and document required modifications for a safe and feasible practice. III. To obtain recruitment estimates and determine barriers to recruitment (acceptability). IV. To evaluate implementation fidelity (adherence and competence) and barriers to implementation fidelity. V. To establish safety. VI. To assess satisfaction. VII. To determine the preliminary efficacy of a modified yoga program for lymphedema in BCS, and associated physical and psychological symptoms/symptom burden, and overall health status. 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.
Interventions
PROCEDUREYoga
Complete guided and home yoga sessions
OTHERtape measurement of arm
Ancillary studies
OTHERQuality-of-Life Assessment
Ancillary studies
OTHERldex measurement of arms
Sponsors
National Cancer Institute (NCI)
Vanderbilt-Ingram Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Lymphedema Group: * Lymphedema, symptomatic of stage II or III based upon screening responses; or L-Dex reading of ≥ 7 at initial visit, * \> 3 months (mths) post-breast cancer treatment * No active cancer * Has compression sleeve * Ability to understand English in order to complete questionnaires * Willing to do guided and home yoga practice * Willing and able to provide informed consent as demonstrated by passing screening tool questions that includes the Short Portable Mental Status Questionnaire * Medical clearance * Reliable transportation to the study site No Lymphedema Group: * No known lymphedema or intermittent swelling, not symptomatic of Stage II or III lymphedema (L-Dex ≥ 7) * \>3 months post- breast cancer treatment * No active cancer * Ability to understand English in order to complete questionnaires * Willing to do guided and home Yoga practice * Willing and able to provide informed consent as demonstrated by passing screening tool questions that includes the Short Portable Mental Status Questionnaire * Medical clearance * Reliable transportation to the study site.
Exclusion criteria
(Both Groups): * Active cancer * Undergoing radiation therapy or chemotherapy * Medical conditions that would prohibit the safe implementation of a yoga practice (e.g., vertigo, compromised mental status) * Active yoga practice \< 3 months * Currently undergoing phase I complete decongestive therapy (CDT) * Inability to complete study forms
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pose Modifications | Up to 8 weeks | number of poses requiring modifications as indicated in the modification form |
| Assess safety | Up to 8 weeks | Number of participants with treatment-related adverse events as assessed by the CTCAE v4.0 |
Countries
United States
Outcome results
None listed