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Hatha Yoga in Breast Cancer Survivors

Primary Purpose

Breast Carcinoma, Lymphedema

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yoga
tape measurement of arm
Quality-of-Life Assessment
ldex measurement of arms
Sponsored by
Vanderbilt-Ingram Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vanderbilt University School of Nursing

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supportive Care (Yoga)

Arm Description

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.

Outcomes

Primary Outcome Measures

Pose Modifications
number of poses requiring modifications as indicated in the modification form
Assess safety
Number of participants with treatment-related adverse events as assessed by the CTCAE v4.0

Secondary Outcome Measures

Full Information

First Posted
September 29, 2016
Last Updated
March 22, 2019
Sponsor
Vanderbilt-Ingram Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02923037
Brief Title
Hatha Yoga in Breast Cancer Survivors
Official Title
Feasibility and Preliminary Efficacy of Hatha Yoga in Breast Cancer Survivors: Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Terminated
Why Stopped
Insufficient staff and funding
Study Start Date
September 1, 2016 (Actual)
Primary Completion Date
November 2018 (Actual)
Study Completion Date
March 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt-Ingram Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Carcinoma, Lymphedema

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supportive Care (Yoga)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Yoga
Intervention Description
Complete guided and home yoga sessions
Intervention Type
Other
Intervention Name(s)
tape measurement of arm
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
ldex measurement of arms
Primary Outcome Measure Information:
Title
Pose Modifications
Description
number of poses requiring modifications as indicated in the modification form
Time Frame
Up to 8 weeks
Title
Assess safety
Description
Number of participants with treatment-related adverse events as assessed by the CTCAE v4.0
Time Frame
Up to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheila Ridner, PhD, RN
Organizational Affiliation
Vanderbilt University School of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University School of Nursing
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Hatha Yoga in Breast Cancer Survivors

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