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

Primary Purpose

Alopecia, Anxiety, Breast Carcinoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Quality-of-Life Assessment
Yoga
Sponsored by
Albert Einstein College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Alopecia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Albert Einstein College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group I (yoga-based rehabilitation program)

Group II (standard care/control)

Arm Description

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.

After a 3 month wait period, participants undergo a yoga-based rehabilitation program as in Group I.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Pain
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
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
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.

Full Information

First Posted
September 13, 2005
Last Updated
May 28, 2023
Sponsor
Albert Einstein College of Medicine
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00179348
Brief Title
Yoga-Based Rehabilitation Program in Reducing Physical and Emotional Side Effects in Patients With Cancer
Official Title
Evaluation of a Yoga-Based Cancer Rehabilitation Program
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
February 8, 2001 (Actual)
Primary Completion Date
July 20, 2016 (Actual)
Study Completion Date
July 20, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Albert Einstein College of Medicine
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
399 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I (yoga-based rehabilitation program)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group II (standard care/control)
Arm Type
Active Comparator
Arm Description
After a 3 month wait period, participants undergo a yoga-based rehabilitation program as in Group I.
Intervention Type
Procedure
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Procedure
Intervention Name(s)
Yoga
Other Intervention Name(s)
Yoga Therapy
Intervention Description
Undergo a yoga-based rehabilitation program
Primary Outcome Measure Information:
Title
Change in Functional Assessment of Cancer Therapy summary score (physical, emotional, spiritual, and social QOL)
Description
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.
Time Frame
Baseline to up to 6 months
Title
Program compliance as measured by Yoga - Daily Practice Calendar and Yoga Class Attendance Record and Yoga Evaluation Form
Description
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.
Time Frame
Up to 6 months
Title
Program satisfaction measured by Yoga - Daily Practice Calendar and Yoga Class Attendance Record and Yoga Evaluation Form
Description
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.
Time Frame
Up to 6 months
Secondary Outcome Measure Information:
Title
Pain
Description
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.
Time Frame
Baseline to up to 6 months
Title
Mood
Description
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.
Time Frame
Baseline to up to 6 months
Title
spiritual well-being
Description
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.
Time Frame
Baseline to up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alyson Moadel
Organizational Affiliation
Albert Einstein College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albert Einstein College of Medicine
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17785709
Citation
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.
Results Reference
derived

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

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