Hatha Yoga in Breast Cancer Survivors
| Status: | Terminated |
|---|---|
| Conditions: | Breast Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/28/2019 |
| Start Date: | September 1, 2016 |
| End Date: | March 2019 |
Feasibility and Preliminary Efficacy of Hatha Yoga in Breast Cancer Survivors: Pilot Study
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).
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).
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.
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.
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
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