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.
Brief Title
Yoga-Based Rehabilitation Program in Reducing Physical and Emotional Side Effects in Patients With 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.
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
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
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
* 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
Inclusion 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
* 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
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT00179348
Org Class
Other
Org Full Name
Albert Einstein College of Medicine
Org Study Id
2000-007
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Evaluation of a Yoga-Based Cancer Rehabilitation Program
Primary Outcomes
Outcome 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.
Outcome Measure
Change in Functional Assessment of Cancer Therapy summary score (physical, emotional, spiritual, and social QOL)
Outcome Time Frame
Baseline to up to 6 months
Outcome 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.
Outcome Measure
Program compliance as measured by Yoga - Daily Practice Calendar and Yoga Class Attendance Record and Yoga Evaluation Form
Outcome Time Frame
Up to 6 months
Outcome 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.
Outcome Measure
Program satisfaction measured by Yoga - Daily Practice Calendar and Yoga Class Attendance Record and Yoga Evaluation Form
Outcome Time Frame
Up to 6 months
Secondary Ids
Secondary Id
NCI-2014-01579
Secondary Id
2000-007
Secondary Id
NCI R03 CA88598-01A1
Secondary Id
01-02-038
Secondary Id
CCI# 00-7
Secondary Id
P30CA013330
Secondary Id
R03CA088598
Secondary Outcomes
Outcome 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.
Outcome Time Frame
Baseline to up to 6 months
Outcome Measure
Pain
Outcome 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.
Outcome Time Frame
Baseline to up to 6 months
Outcome Measure
Mood
Outcome 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.
Outcome Time Frame
Baseline to up to 6 months
Outcome Measure
spiritual well-being
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Alyson Moadel
Investigator Email
alyson.moadel-robblee@einsteinmed.org
Investigator Phone
718-430-2696