Hatha Yoga in Breast Cancer Survivors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02923037|
Recruitment Status : Terminated (Insufficient staff and funding)
First Posted : October 4, 2016
Last Update Posted : March 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breast Carcinoma Lymphedema||Procedure: Yoga Other: tape measurement of arm Other: Quality-of-Life Assessment Other: ldex measurement of arms||Not Applicable|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Feasibility and Preliminary Efficacy of Hatha Yoga in Breast Cancer Survivors: Pilot Study|
|Actual Study Start Date :||September 1, 2016|
|Actual Primary Completion Date :||November 2018|
|Actual Study Completion Date :||March 2019|
Experimental: 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.
Complete guided and home yoga sessions
Other: tape measurement of arm
Other: Quality-of-Life Assessment
Other: ldex measurement of arms
- Pose Modifications [ Time Frame: Up to 8 weeks ]number of poses requiring modifications as indicated in the modification form
- Assess safety [ Time Frame: Up to 8 weeks ]Number of participants with treatment-related adverse events as assessed by the CTCAE v4.0
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02923037
|United States, Tennessee|
|Vanderbilt University School of Nursing|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||Sheila Ridner, PhD, RN||Vanderbilt University School of Nursing|