Feasibility and Preliminary Efficacy of Hatha Yoga in Breast Cancer Survivors: Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- Assess safety
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
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.
Intervention: Yoga (Procedure)
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.
Intervention: tape measurement of arm (Other)
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.
Intervention: Quality-of-Life Assessment (Other)
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.
Intervention: ldex measurement of arms (Other)
Outcomes
Primary Outcomes
Assess safety
Time Frame: Up to 8 weeks
Number of participants with treatment-related adverse events as assessed by the CTCAE v4.0
Pose Modifications
Time Frame: Up to 8 weeks
number of poses requiring modifications as indicated in the modification form
Secondary Outcomes
No secondary outcomes reported
Investigators
Sheila Ridner
Principal Investigator
Vanderbilt-Ingram Cancer Center