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Yoga-Based Cancer Rehabilitation Program

This study is currently recruiting participants.
Verified February 2012 by Albert Einstein College of Medicine of Yeshiva University
Sponsor:
Collaborators:
National Cancer Institute (NCI)
The Jacob and Valeria Langeloth Foundation
Information provided by (Responsible Party):
Alyson Moadel, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier:
NCT00179348
First received: September 13, 2005
Last updated: February 1, 2012
Last verified: February 2012
History of Changes
  Purpose

The purpose of this study is to find out if a Yoga-Based Cancer Rehabilitation Program can help reduce the physical and emotional side effects of living with cancer or its treatment.


Condition Intervention
Breast Neoplasms
Colorectal Neoplasms
Lung Neoplasms
 Behavioral: Yoga

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Evaluation of a Yoga-Based Cancer Rehabilitation Program

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Albert Einstein College of Medicine of Yeshiva University:

Primary Outcome Measures:
  • Functional Assessment of Cancer Therapy [ Time Frame: Baseline to 3 months and 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: April 2001
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Yoga (weekly class based on Integral Hatha yoga techniques conducted in a chair)
 Behavioral: Yoga
12-weeks of a gentle, seated Integral Hath yoga class, comprised of gentle stretching, breathing exercises, and meditation
No Intervention: 2
Waitlist control arm

Detailed Description:

Research on yoga is extensive in both healthy and chronically ill individuals including cardiovascular disease, chronic pain, diabetes, asthma, headache, anxiety and depression. Benefits of yoga include: improved mood, energy, memory, concentration, flexibility, physical fitness, breathing capacity, and decreased pain, blood pressure, and cholesterol. There is paucity of controlled research studies on the effects of yoga for cancer patients. Yoga is an ideal intervention to improve quality of life for patients with cancer because it incorporates elements of relaxation, social support, and exercise, all found to improve quality of life. This randomized-controlled study compares a 12-week yoga intervention to standard care on quality of life among patients with early-stage breast, lung, and colorectal cancer. Quality of life assessments are conducted at baseline, and at one, three, and six month intervals.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Breast Cancer (Stages I, II, or III), Colorectal Cancer (Stages I, II, or III), or Lung Cancer (Stages I, II)
  • Diagnosed with new or recurrent cancer within past 5 years
  • Language is English or Spanish
  • Recovered from surgery and any postoperative complications requiring hospitalization

Exclusion Criteria:

  • Current Yoga Practice >1x month
  • Unable to attend yoga class due to time conflict
  • Advanced cancer with symptomatic pulmonary, skeletal or brain metastases
  • Second Primary cancer that is active
  • ECOG performance status of 3 or 4
  • Seizures
  • Arthritis or muscle pain, if severe enough to interfere with simple Yogic exercises
  • Asthma or difficulty breathing, if severe enough to interfere with ability to perform deep breathing
  • Uncontrolled hypertension
  • Heart condition or problems
  • Current (Uncontrolled) major psychiatric disorder
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00179348

Contacts
Contact: Alyson Moadel, Ph.D. 718-430-2696 alyson.moadel@einstein.yu.edu

Locations
United States, New York
Albert Einstein College of Medicine Recruiting
Bronx, New York, United States, 10461
Contact: Alyson Moadel, Ph.D.     718-430-2696     alyson.moadel@einstein.yu.edu    
Principal Investigator: Alyson Moadel, Ph.D.            
Sponsors and Collaborators
Albert Einstein College of Medicine of Yeshiva University
National Cancer Institute (NCI)
The Jacob and Valeria Langeloth Foundation
Investigators
Principal Investigator: Alyson Moadel, Ph.D. Albert Einstein College of Medicine of Yeshiva University
  More Information

Additional Information:
Support programs for cancer patients and their families in the Bronx  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Alyson Moadel, Associate Professor, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier: NCT00179348     History of Changes
Other Study ID Numbers: #2000-007, NCI R03 CA88598-01A1
Study First Received: September 13, 2005
Last Updated: February 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Albert Einstein College of Medicine of Yeshiva University:
Yoga
Breast Neoplasms
Colorectal Neoplasms
Lung Neoplasms

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Colorectal Neoplasms
Lung Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 19, 2013