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
Conditions
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.
Interventions
PROCEDUREQuality-of-Life Assessment
Ancillary studies
PROCEDUREYoga
Undergo a yoga-based rehabilitation program
Sponsors
National Cancer Institute (NCI)
Albert Einstein College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Countries
United States
Outcome results
None listed