Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Yoga-Based Rehabilitation Program in Reducing Physical and Emotional Side Effects in Patients With Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
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: December 9, 2015
Last verified: July 2015
  Purpose
This clinical trial studies yoga-based rehabilitation in reducing physical and emotional side effects of living with cancer or its treatment. Yoga-based rehabilitation may reduce side effects and improve the quality of life of patients with breast, lung, or colorectal cancer.

Condition Intervention
Alopecia
Anxiety
Breast Carcinoma
Cognitive Side Effects of Cancer Therapy
Colorectal Carcinoma
Depression
Fatigue
Lung Carcinoma
Nausea and Vomiting
Pain
Psychological Impact of Cancer
Sleep Disorder
Weight Change
Procedure: Quality-of-Life Assessment
Procedure: 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:


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

Primary Outcome Measures:
  • Change in Functional Assessment of Cancer Therapy summary score (physical, emotional, spiritual, and social QOL) [ Time Frame: Baseline to up to 6 months ] [ Designated as safety issue: No ]
    A repeated measures analysis of covariance will be performed for each of the five patient groups. This analysis will examine between and within group differences at T2 and T3 assessment points, after controlling for baseline levels of QOL.

  • Program compliance as measured by Yoga - Daily Practice Calendar and Yoga Class Attendance Record and Yoga Evaluation Form [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    Descriptive analyses (percentages) will be conducted to examine levels of compliance (class attendance + home practice) for each patient group, self-identified ethnic group, and language of preference. Logistic regression analyses will be performed to identify patients in the top 25% for compliance based on sociocultural, medical, and lifestyle factors.

  • Program satisfaction measured by Yoga - Daily Practice Calendar and Yoga Class Attendance Record and Yoga Evaluation Form [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    Descriptive analyses (percentages) will be conducted to examine levels of satisfaction (total score on yoga evaluation form) for each patient group, self-identified ethnic group, and language of preference. Logistic regression analyses will be performed to identify patients in the top 25% for satisfaction based on sociocultural, medical, and lifestyle factors.


Secondary Outcome Measures:
  • Pain [ Time Frame: Baseline to up to 6 months ] [ Designated as safety issue: No ]
    Medical chart data will be examined and three separate one-way analysis of variances will be conducted to examine mean differences in adverse medical events, compliance with cancer treatment, and use of pharmacotherapy between intervention and control for each of the five cancer patient groups.

  • Mood [ Time Frame: Baseline to up to 6 months ]
    Medical chart data will be examined and three separate one-way analysis of variances will be conducted to examine mean differences in adverse medical events, compliance with cancer treatment, and use of pharmacotherapy between intervention and control for each of the five cancer patient groups.

  • spiritual well-being [ Time Frame: Baseline to up to 6 months ]
    Medical chart data will be examined and three separate one-way analysis of variances will be conducted to examine mean differences in adverse medical events, compliance with cancer treatment, and use of pharmacotherapy between intervention and control for each of the five cancer patient groups.


Estimated Enrollment: 250
Study Start Date: February 2001
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group I (yoga-based rehabilitation program)
Participants undergo a yoga-based rehabilitation program up to 5 days a week for 1.5 hours and practice at home at least once daily for 12 weeks.
Procedure: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment
Procedure: Yoga
Undergo a yoga-based rehabilitation program
Other Name: Yoga Therapy
Active Comparator: Group II (standard care/control)
After a 3 month wait period, participants undergo a yoga-based rehabilitation program as in Group I.
Procedure: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment
Procedure: Yoga
Undergo a yoga-based rehabilitation program
Other Name: Yoga Therapy

Detailed Description:

PRIMARY OBJECTIVES:

I. To evaluate the effects of yoga on quality of life (QOL) of breast cancer patients on different treatment regimens.

II. To pilot the effects of a yoga-based rehabilitation program versus standard care on QOL impairment reported by newly diagnosed (a) lung and (b) colorectal patients.

III. To evaluate program compliance and satisfaction among breast, lung and colorectal cancer patients as well as among the various sociocultural subgroups (e.g., ethnicity, language).

OUTLINE: Participants are randomized to 1 of 2 arms.

GROUP I (YOGA-BASED REHABILITATION PROGRAM): Participants undergo a yoga-based rehabilitation program up to 5 days a week for 1.5 hours and practice at home at least once daily for 12 weeks.

GROUP II (STANDARD CARE/CONTROL): After a 3 month wait period, participants undergo yoga-based rehabilitation program as in Group I.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have been diagnosed with breast, lung or colorectal cancer in the previous 8 weeks
  • Are to receive oncologic care at the Albert Einstein Cancer Center (AECC)
  • Have a life-expectancy of at least 6 months
  • Are either English- or Spanish-speaking
  • Do not practice yoga regularly (> 1 month)
  • Receive medical clearance by oncologic personnel on the study

Exclusion Criteria:

  • Eastern Cooperative Oncology Group performance status >= 3
  • Existence of any of the following:

    • Seizure disorder
    • Musculoskeletal conditions
    • Heart problems
    • Major psychiatric disorder
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00179348

Locations
United States, New York
Albert Einstein College of Medicine
Bronx, New York, United States, 10461
Sponsors and Collaborators
Albert Einstein College of Medicine of Yeshiva University
National Cancer Institute (NCI)
Investigators
Principal Investigator: Alyson Moadel Albert Einstein College of Medicine of Yeshiva University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alyson Moadel, Principal Investigator, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier: NCT00179348     History of Changes
Other Study ID Numbers: CCI# 00-7  NCI-2014-01579  2000-007  NCI R03 CA88598-01A1  01-02-038  CCI# 00-7  P30CA013330  R03CA088598 
Study First Received: September 13, 2005
Last Updated: December 9, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma
Fatigue
Vomiting
Breast Neoplasms
Lung Neoplasms
Alopecia
Sleep Wake Disorders
Parasomnias
Colorectal Neoplasms
Body Weight Changes
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Signs and Symptoms
Signs and Symptoms, Digestive
Neoplasms by Site
Breast Diseases
Skin Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Hypotrichosis
Hair Diseases
Pathological Conditions, Anatomical
Nervous System Diseases
Neurologic Manifestations
Mental Disorders
Intestinal Neoplasms
Gastrointestinal Neoplasms

ClinicalTrials.gov processed this record on December 08, 2016