Yoga-Based Rehabilitation Program in Reducing Physical and Emotional Side Effects in Patients With Cancer
Evaluation of a Yoga-Based Cancer Rehabilitation Program
7 other identifiers
interventional
399
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2001
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 8, 2001
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 16, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 20, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 20, 2016
CompletedMay 31, 2023
May 1, 2023
15.5 years
September 13, 2005
May 28, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
Change in Functional Assessment of Cancer Therapy summary score (physical, emotional, spiritual, and social QOL)
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
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
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 Outcomes (3)
Pain
Baseline to up to 6 months
Mood
Baseline to up to 6 months
spiritual well-being
Baseline to up to 6 months
Study Arms (2)
Group I (yoga-based rehabilitation program)
EXPERIMENTALParticipants 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)
ACTIVE COMPARATORAfter a 3 month wait period, participants undergo a yoga-based rehabilitation program as in Group I.
Interventions
Ancillary studies
Undergo a yoga-based rehabilitation program
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Eastern Cooperative Oncology Group performance status \>= 3
- Existence of any of the following:
- Seizure disorder
- Musculoskeletal conditions
- Heart problems
- Major psychiatric disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Albert Einstein College of Medicine
The Bronx, New York, 10461, United States
Related Publications (1)
Moadel AB, Shah C, Wylie-Rosett J, Harris MS, Patel SR, Hall CB, Sparano JA. Randomized controlled trial of yoga among a multiethnic sample of breast cancer patients: effects on quality of life. J Clin Oncol. 2007 Oct 1;25(28):4387-95. doi: 10.1200/JCO.2006.06.6027. Epub 2007 Sep 4.
PMID: 17785709DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alyson Moadel
Albert Einstein College of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 16, 2005
Study Start
February 8, 2001
Primary Completion
July 20, 2016
Study Completion
July 20, 2016
Last Updated
May 31, 2023
Record last verified: 2023-05