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

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ClinicalTrials.gov Identifier: NCT00179348
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : January 24, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alyson Moadel, Albert Einstein College of Medicine

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 16, 2005
Last Update Posted Date January 24, 2017
Actual Study Start Date  ICMJE February 8, 2001
Actual Primary Completion Date July 20, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 9, 2015)
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
QOL Assessment Interviews at Baseline, 1 month, 3 months, and 6 months
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 9, 2015)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Yoga-Based Rehabilitation Program in Reducing Physical and Emotional Side Effects in Patients With Cancer
Official Title  ICMJE Evaluation of a Yoga-Based Cancer Rehabilitation Program
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • 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
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Procedure: Quality-of-Life Assessment
    • Procedure: Yoga
  • Active Comparator: Group II (standard care/control)
    After a 3 month wait period, participants undergo a yoga-based rehabilitation program as in Group I.
    Interventions:
    • Procedure: Quality-of-Life Assessment
    • Procedure: Yoga
Publications * 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. Epub 2007 Sep 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 23, 2017)
399
Original Enrollment  ICMJE
 (submitted: September 13, 2005)
250
Actual Study Completion Date  ICMJE July 20, 2016
Actual Primary Completion Date July 20, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00179348
Other Study ID Numbers  ICMJE CCI# 00-7
NCI-2014-01579 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2000-007
NCI R03 CA88598-01A1
01-02-038
CCI# 00-7 ( Other Identifier: Albert Einstein College of Medicine )
P30CA013330 ( U.S. NIH Grant/Contract )
R03CA088598 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alyson Moadel, Albert Einstein College of Medicine
Study Sponsor  ICMJE Albert Einstein College of Medicine
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Alyson Moadel Albert Einstein College of Medicine
PRS Account Albert Einstein College of Medicine
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP