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

Not Applicable

Completed

Conditions: Cognitive Side Effects of Cancer Therapy
Depression
Fatigue
Alopecia
Anxiety
Colorectal Carcinoma
Nausea and Vomiting
Psychological Impact of Cancer
Weight Change
Sleep Disorder

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Group I (yoga-based rehabilitation program)	Quality-of-Life Assessment	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 I (yoga-based rehabilitation program)	Yoga	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)	Quality-of-Life Assessment	After a 3 month wait period, participants undergo a yoga-based rehabilitation program as in Group I.
Group II (standard care/control)	Yoga	After a 3 month wait period, participants undergo a yoga-based rehabilitation program as in Group I.

Primary Outcome Measures

Name	Time	Method
Change in Functional Assessment of Cancer Therapy summary score (physical, emotional, spiritual, and social QOL)	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	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	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.

Secondary Outcome Measures

Name	Time	Method
Pain	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	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	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.

Locations (1): Albert Einstein College of Medicine
🇺🇸
Bronx, New York, United States