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| ID | Type | Description | Link |
|---|---|---|---|
| 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 | View source | |
| R03CA088598 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (yoga-based rehabilitation program) | Experimental | 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) | Active Comparator | After a 3 month wait period, participants undergo a yoga-based rehabilitation program as in Group I. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quality-of-Life Assessment | Procedure | Ancillary studies |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Eastern Cooperative Oncology Group performance status >= 3
Existence of any of the following:
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| Name | Affiliation | Role |
|---|---|---|
| Alyson Moadel | Albert Einstein College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albert Einstein College of Medicine | The Bronx | New York | 10461 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17785709 | Derived | 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. |
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| Yoga | Procedure | Undergo a yoga-based rehabilitation program |
|
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| 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 |
| ID | Term |
|---|---|
| D000505 | Alopecia |
| D001008 | Anxiety Disorders |
| D001943 | Breast Neoplasms |
| D015179 | Colorectal Neoplasms |
| D003863 | Depression |
| D005221 | Fatigue |
| D008175 | Lung Neoplasms |
| D009325 | Nausea |
| D014839 | Vomiting |
| D010146 | Pain |
| D012893 | Sleep Wake Disorders |
| D001836 | Body Weight Changes |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D012816 | Signs and Symptoms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D015013 | Yoga |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
| D026241 | Exercise Movement Techniques |
| D026741 | Physical Therapy Modalities |
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