Breast Cancer Clinical Trial

Hatha Yoga in Breast Cancer Survivors

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).

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Full 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.

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Breast Cancer

Estimated Enrollment:

27

Study ID:

NCT02923037

Recruitment Status:

Terminated

Sponsor:

Vanderbilt-Ingram Cancer Center

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There is 1 Location for this study

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Vanderbilt University School of Nursing
Nashville Tennessee, 37232, United States

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Study is for people with:

Breast Cancer

Estimated Enrollment:

27

Study ID:

NCT02923037

Recruitment Status:

Terminated

Sponsor:


Vanderbilt-Ingram Cancer Center

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