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Effect of Sukshma Vyayama Yoga on Aromatase Inhibitor-Induced Arthralgia in Breast Cancer Survivors

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Joint Loosening Yoga
Sponsored by
AshtaYoga, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Breast Cancer, Yoga, Aromatase Inhibitor, Arthralgia, Sukshma Vyayama

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Postmenopausal breast cancer survivors undergoing treatment with aromatase inhibitor hormonal therapy with self-reported arthralgia
  • Must have initiated anastrazole, exemestane, or letrozole within 30 days of baseline assessment
  • 35-70 years old
  • Must be available during the dates of the study and willing to participate in the study
  • Must have access to computer, tablet or smart phone and Internet connection
  • Must be a member of Facebook
  • Eligible if their arthralgia started after initiation of an AI or if they had preexisting joint pain that was exacerbated by AI use
  • English speaking

Exclusion Criteria:

  • Non English-speaking
  • Physically unable to perform the intervention

Sites / Locations

  • Columbia University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Joint Loosening Yoga

Arm Description

Yoga Intervention. Dose: 15 minutes, M-F for 4-weeks.

Outcomes

Primary Outcome Measures

Change in Patient-Reported Arthralgia Inventory (PRAI) Measure for Joint Arthralgia
The Patient-Reported Arthralgia Inventory measures self-reported pain intensity in 16 specific joints over the past 7 days. This questionnaire consists of 16 questions answered on a 0 to 10 scale (0 = no pain at all; 10 = worst pain you can imagine) with a min of 0 and a max of 160. Higher scores indicate more pain.
Change in Brief Pain Inventory Short Form (BPI SF) Measure for Body Pain
The Brief Pain Inventory Short Form measures self-reported pain intensity in the body in the last 24-hours. This questionnaire consists of 8 questions (4 on pain quality) answered on a scale 0-10 (0 = no pain; 10 = pain as bad as you can imagine) with a min of 0 and a max of 40. Higher scores indicate more pain.
Change in Brief Pain Inventory Short Form (BPI SF) Measure for Quality of Life
The Brief Pain Inventory Short Form measures self-reported QoL in the last 24-hours. This questionnaire consists of 7 questions answered on a scale 0-10 (0 = does not interfere; 10 = completely interferes) with a min of 0 and a max of 70. Higher scores indicate lower QoL.
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Measure for Pain, Stiffness, and Physical Function of Knee and Hip
The Western Ontario and McMaster Universities Osteoarthritis Index measures self-reported pain, stiffness, and functional limitation of knee and hip during activity in the last 48-hours. This questionnaire consists of 24 questions answered on a scale 0-4 (0 = none; 4 = extreme). Measures include five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). Higher scores indicate greater pain, stiffness, and functional limitation.
Change in Disability of the Arm, Shoulder and Hand (DASH) Measure of Ability to Use Arm, Shoulder, and Hand
The Disability of the Arm, Shoulder and Hand tool measures self-reported ability to do daily activities in the last week and impact on QoL. The questionnaire consists of 30 questions answered on a scale 1-5 (1 = no difficulty; 5 = unable) with a min of 30 and a max of 150. Measures include 21 items for daily functional activity (score range 30-105), two for interference with social or work activity (score range 2-10), five for pain and discomfort (score range 5-25), one for sleep (score range 1-5), and one for confidence (score range 1-5). Higher scores indicate greater pain and disability.

Secondary Outcome Measures

Effectiveness of Delivering Intervention on Facebook
Measure whether sufficient numbers of subjects enroll in order to complete the study.

Full Information

First Posted
July 14, 2019
Last Updated
August 1, 2019
Sponsor
AshtaYoga, LLC
Collaborators
Columbia University, Swami Vivekananda Yoga Anusandhana Samsthana
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1. Study Identification

Unique Protocol Identification Number
NCT04042870
Brief Title
Effect of Sukshma Vyayama Yoga on Aromatase Inhibitor-Induced Arthralgia in Breast Cancer Survivors
Official Title
Effect of Sukshma Vyayama Joint Loosening Yoga on Aromatase Inhibitor-Induced Arthralgia in Post-Menopausal Breast Cancer Survivors: A Feasibility Study Conducted on Facebook
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
September 4, 2018 (Actual)
Primary Completion Date
September 28, 2018 (Actual)
Study Completion Date
October 19, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AshtaYoga, LLC
Collaborators
Columbia University, Swami Vivekananda Yoga Anusandhana Samsthana

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to investigate the efficacy of sukshma vyayama joint loosening yoga in improving aromatase inhibitor-induced arthralgia in post-menopausal breast cancer survivors and secondarily, to evaluate the feasibility of delivering the intervention on Facebook.
Detailed Description
Cancer survival rates are improving in the United States but this increased survivorship is offset by persistent treatment related symptoms, particularly for post-menopausal breast cancer survivors treated with aromatase inhibitor (AI) hormonal therapy. AI therapy is well known to cause arthralgia that can compromise a woman's quality of life. National Comprehensive Cancer Center Network (NCCCN) guidelines for breast cancer treatment recommend that post-menopausal women with estrogen receptor-positive tumors receive aromatase inhibitors, e.g., anastrozole (Arimidex), letrozole (Femara) or exemestane (Aromasin) as a key part of treatment to lower the risk of breast cancer recurrence, breast cancer in the opposite breast, and death from breast cancer. Estrogen receptor-positive breast cancer represents almost 50% of all newly diagnosed cases of breast cancer. Currently, AIs are prescribed for five to ten years. The length of this treatment, coupled with difficult arthritic side effects can make it difficult for patients to complete therapy. Arthralgia occurs in up to 50% of breast cancer survivors treated with AIs and is the most common reason for poor AI adherence. Up to 50% of patients do not take AIs as prescribed and up to 20% will become non-compliant with treatment within the first year due to pain and discomfort. To get the most benefit out of hormone therapy, however, patients must take the full course of treatment. Both non-adherence and early discontinuation of AIs have been shown to be independent predictors of mortality. Women who complete the full course have better survival than those who do not. Given the efficacy of AIs in preventing breast cancer recurrence, and the proportion of women who discontinue these drugs because of adverse events, interventions to improve adverse effects are important. This study investigated the efficacy of sukshma vyayama joint loosening yoga in reducing and improving aromatase inhibitor-induced joint pain and achiness in post-menopausal breast cancer patients, and evaluated the feasibility of delivering the intervention on Facebook. Hypothesis: Given global disparities in healthcare, being able to safely deliver evidence-based yoga interventions via the internet is important.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast Cancer, Yoga, Aromatase Inhibitor, Arthralgia, Sukshma Vyayama

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Joint Loosening Yoga
Arm Type
Experimental
Arm Description
Yoga Intervention. Dose: 15 minutes, M-F for 4-weeks.
Intervention Type
Behavioral
Intervention Name(s)
Joint Loosening Yoga
Intervention Description
Sukshma Vyayama Joint Loosening Yoga was practiced Monday - Friday for four weeks. Each session included twelve joint loosening exercises performed in a chair, each performed 10 times with mindful awareness of physical movements and breath synchronization. Sessions lasted 15 minutes.
Primary Outcome Measure Information:
Title
Change in Patient-Reported Arthralgia Inventory (PRAI) Measure for Joint Arthralgia
Description
The Patient-Reported Arthralgia Inventory measures self-reported pain intensity in 16 specific joints over the past 7 days. This questionnaire consists of 16 questions answered on a 0 to 10 scale (0 = no pain at all; 10 = worst pain you can imagine) with a min of 0 and a max of 160. Higher scores indicate more pain.
Time Frame
Baseline and Four weeks
Title
Change in Brief Pain Inventory Short Form (BPI SF) Measure for Body Pain
Description
The Brief Pain Inventory Short Form measures self-reported pain intensity in the body in the last 24-hours. This questionnaire consists of 8 questions (4 on pain quality) answered on a scale 0-10 (0 = no pain; 10 = pain as bad as you can imagine) with a min of 0 and a max of 40. Higher scores indicate more pain.
Time Frame
Baseline and Four weeks
Title
Change in Brief Pain Inventory Short Form (BPI SF) Measure for Quality of Life
Description
The Brief Pain Inventory Short Form measures self-reported QoL in the last 24-hours. This questionnaire consists of 7 questions answered on a scale 0-10 (0 = does not interfere; 10 = completely interferes) with a min of 0 and a max of 70. Higher scores indicate lower QoL.
Time Frame
Baseline and Four weeks
Title
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Measure for Pain, Stiffness, and Physical Function of Knee and Hip
Description
The Western Ontario and McMaster Universities Osteoarthritis Index measures self-reported pain, stiffness, and functional limitation of knee and hip during activity in the last 48-hours. This questionnaire consists of 24 questions answered on a scale 0-4 (0 = none; 4 = extreme). Measures include five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). Higher scores indicate greater pain, stiffness, and functional limitation.
Time Frame
Baseline and Four weeks
Title
Change in Disability of the Arm, Shoulder and Hand (DASH) Measure of Ability to Use Arm, Shoulder, and Hand
Description
The Disability of the Arm, Shoulder and Hand tool measures self-reported ability to do daily activities in the last week and impact on QoL. The questionnaire consists of 30 questions answered on a scale 1-5 (1 = no difficulty; 5 = unable) with a min of 30 and a max of 150. Measures include 21 items for daily functional activity (score range 30-105), two for interference with social or work activity (score range 2-10), five for pain and discomfort (score range 5-25), one for sleep (score range 1-5), and one for confidence (score range 1-5). Higher scores indicate greater pain and disability.
Time Frame
Baseline and Four weeks
Secondary Outcome Measure Information:
Title
Effectiveness of Delivering Intervention on Facebook
Description
Measure whether sufficient numbers of subjects enroll in order to complete the study.
Time Frame
Four Weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women with estrogen receptor-positive breast cancer prescribed and currently taking aromatase inhibitor therapy.
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Postmenopausal breast cancer survivors undergoing treatment with aromatase inhibitor hormonal therapy with self-reported arthralgia Must have initiated anastrazole, exemestane, or letrozole within 30 days of baseline assessment 35-70 years old Must be available during the dates of the study and willing to participate in the study Must have access to computer, tablet or smart phone and Internet connection Must be a member of Facebook Eligible if their arthralgia started after initiation of an AI or if they had preexisting joint pain that was exacerbated by AI use English speaking Exclusion Criteria: Non English-speaking Physically unable to perform the intervention
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leigh Leibel, MSc
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Leibel L, Metri K, Prasad R, Mears JG, Effect of Sukshma Vyayama on Aromatase Inhibitor-Induced Arthralgia in Post-Menopausal Breast Cancer Survivors: A Feasibility Study Conducted on Facebook, J Clin Oncol 37, 2019 (suppl; abstr e23129)
Results Reference
result

Learn more about this trial

Effect of Sukshma Vyayama Yoga on Aromatase Inhibitor-Induced Arthralgia in Breast Cancer Survivors

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