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

May 28, 2023 updated by: Albert Einstein College of Medicine

Evaluation of a Yoga-Based Cancer Rehabilitation Program

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

399

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10461
        • Albert Einstein College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Quality of Life Assessment
Procedure: Yoga
Undergo a yoga-based rehabilitation program
Other Names:
  • 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 Names:
  • Quality of Life Assessment
Procedure: Yoga
Undergo a yoga-based rehabilitation program
Other Names:
  • Yoga Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Functional Assessment of Cancer Therapy summary score (physical, emotional, spiritual, and social QOL)
Time Frame: Baseline to up to 6 months
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.
Baseline to up to 6 months
Program compliance as measured by Yoga - Daily Practice Calendar and Yoga Class Attendance Record and Yoga Evaluation Form
Time Frame: Up to 6 months
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.
Up to 6 months
Program satisfaction measured by Yoga - Daily Practice Calendar and Yoga Class Attendance Record and Yoga Evaluation Form
Time Frame: Up to 6 months
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.
Up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain
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.
Baseline to up to 6 months
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.
Baseline to up to 6 months
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.
Baseline to up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Albert Einstein College of Medicine

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Alyson Moadel, Albert Einstein College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 8, 2001

Primary Completion (Actual)

July 20, 2016

Study Completion (Actual)

July 20, 2016

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimated)

September 16, 2005

Study Record Updates

Last Update Posted (Actual)

May 31, 2023

Last Update Submitted That Met QC Criteria

May 28, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000-007
  • P30CA013330 (U.S. NIH Grant/Contract)
  • CCI# 00-7 (Other Identifier: Albert Einstein College of Medicine)
  • NCI-2014-01579 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • NCI R03 CA88598-01A1
  • 01-02-038
  • R03CA088598 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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