Clinical trial NCT02923037: Hatha Yoga in Breast Cancer Survivors
Official title: Feasibility and Preliminary Efficacy of Hatha Yoga in Breast Cancer Survivors: Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Carcinoma
Lymphedema
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-10-04
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

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

Primary outcomes:
measure: Pose Modifications
timeFrame: Up to 8 weeks
measure: Assess safety
timeFrame: Up to 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University School of Nursing
state: Tennessee
Study officials:
affiliation: Vanderbilt University School of Nursing
name: Sheila Ridner, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: