Hatha Yoga in Breast Cancer Survivors

Study Overview
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Brief Summary
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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
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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.

Official Title
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Feasibility and Preliminary Efficacy of Hatha Yoga in Breast Cancer Survivors: Pilot Study

Conditions
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Breast Carcinoma, Lymphedema

Intervention / Treatment
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* Procedure: Yoga
* Other: tape measurement of arm
* Other: Quality-of-Life Assessment
* Other: ldex measurement of arms


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive Care (Yoga)<br>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. They will have tape measurement of arms and ldex measurement of arms. Quality-of-Life Assessment will also be made. | Procedure: Yoga<br>* Complete guided and home yoga sessions<br>Other: tape measurement of arm<br>* Ancillary studies<br>Other: Quality-of-Life Assessment<br>* Ancillary studies<br>Other: ldex measurement of arms<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pose Modifications | number of poses requiring modifications as indicated in the modification form | Up to 8 weeks | 
| Assess safety | Number of participants with treatment-related adverse events as assessed by the CTCAE v4.0 | Up to 8 weeks |