Hatha Yoga in Breast Cancer Survivors
Feasibility and Preliminary Efficacy of Hatha Yoga in Breast Cancer Survivors: Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Tennessee
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Nashville, Tennessee, United States, 37232
- Vanderbilt University School of Nursing
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Supportive Care (Yoga)
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.
|
Ancillary studies
Complete guided and home yoga sessions
Ancillary studies
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pose Modifications
Time Frame: Up to 8 weeks
|
number of poses requiring modifications as indicated in the modification form
|
Up to 8 weeks
|
|
Assess safety
Time Frame: Up to 8 weeks
|
Number of participants with treatment-related adverse events as assessed by the CTCAE v4.0
|
Up to 8 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VICC BRE 16104
- NCI-2016-01402 (REGISTRY: NCI, Clinical Trials Reporting Program)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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