Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
27 participants
INTERVENTIONAL
2016-09-01
2019-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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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.
Yoga
Complete guided and home yoga sessions
tape measurement of arm
Ancillary studies
Quality-of-Life Assessment
Ancillary studies
ldex measurement of arms
Interventions
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Yoga
Complete guided and home yoga sessions
tape measurement of arm
Ancillary studies
Quality-of-Life Assessment
Ancillary studies
ldex measurement of arms
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Vanderbilt-Ingram Cancer Center
OTHER
Responsible Party
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Sheila Ridner
Principal Investigator
Principal Investigators
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Sheila Ridner, PhD, RN
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University School of Nursing
Locations
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Vanderbilt University School of Nursing
Nashville, Tennessee, United States
Countries
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Other Identifiers
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NCI-2016-01402
Identifier Type: REGISTRY
Identifier Source: secondary_id
VICC BRE 16104
Identifier Type: -
Identifier Source: org_study_id
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