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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
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sheila Ridner, Vanderbilt-Ingram Cancer Center

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).

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

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.

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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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Procedure: Yoga
Complete guided and home yoga sessions

Other: tape measurement of arm
Ancillary studies

Other: Quality-of-Life Assessment
Ancillary studies

Other: ldex measurement of arms



Primary Outcome Measures :
  1. Pose Modifications [ Time Frame: Up to 8 weeks ]
    number of poses requiring modifications as indicated in the modification form

  2. Assess safety [ Time Frame: Up to 8 weeks ]
    Number of participants with treatment-related adverse events as assessed by the CTCAE v4.0



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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United States, Tennessee
Vanderbilt University School of Nursing
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Sheila Ridner, PhD, RN Vanderbilt University School of Nursing

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Responsible Party: Sheila Ridner, Principal Investigator, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT02923037    
Other Study ID Numbers: VICC BRE 16104
NCI-2016-01402 ( Registry Identifier: NCI, Clinical Trials Reporting Program )
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Breast Neoplasms
Lymphedema
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Lymphatic Diseases