Hatha Yoga in Breast Cancer Survivors

Lymphedema Clinical Trial

Official title:

Feasibility and Preliminary Efficacy of Hatha Yoga in Breast Cancer Survivors: Pilot Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02923037
• Other study ID #: VICC BRE 16104
• Secondary ID: NCI-2016-01402
• Status: Terminated
• Phase: N/A
• Start date: September 1, 2016
• Est. completion date: March 2019

Study information

• Verified date: March 2019
• Source: Vanderbilt-Ingram Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: March 2019
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Carcinoma
• Breast Neoplasms
• Lymphedema

Intervention

Procedure:
• Yoga
Complete guided and home yoga sessions

Other:
• tape measurement of arm
Ancillary studies
• Quality-of-Life Assessment
Ancillary studies
• ldex measurement of arms

Locations

Country	Name	City	State
United States	Vanderbilt University School of Nursing	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pose Modifications	number of poses requiring modifications as indicated in the modification form	Up to 8 weeks
Primary	Assess safety	Number of participants with treatment-related adverse events as assessed by the CTCAE v4.0	Up to 8 weeks