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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of a Yoga-Based Cancer Rehabilitation Program

Conditions
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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 / Treatment
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* Procedure: Quality-of-Life Assessment
* Procedure: Yoga


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I (yoga-based rehabilitation program)<br>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<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Procedure: Yoga<br>* Undergo a yoga-based rehabilitation program<br>* Other names: Yoga Therapy;|
| Active Comparator: Group II (standard care/control)<br>After a 3 month wait period, participants undergo a yoga-based rehabilitation program as in Group I. | Procedure: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Procedure: Yoga<br>* Undergo a yoga-based rehabilitation program<br>* Other names: Yoga Therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline to up to 6 months | 
| 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. | Baseline to up to 6 months | 
| 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. | Baseline to up to 6 months |