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

Depression Clinical Trial

Official title:

Evaluation of a Yoga-Based Cancer Rehabilitation Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00179348
• Other study ID #: 2000-007
• Secondary ID: NCI-2014-0157920
• Status: Completed
• Phase: N/A
• Start date: February 8, 2001
• Est. completion date: July 20, 2016

Study information

• Verified date: May 2023
• Source: Albert Einstein College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 399
• Est. completion date: July 20, 2016
• Est. primary completion date: July 20, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Alopecia
• Anxiety
• Breast Carcinoma
• Breast Neoplasms
• Carcinoma
• Cognitive Side Effects of Cancer Therapy
• Colorectal Carcinoma
• Colorectal Neoplasms
• Depression
• Fatigue
• Lung Carcinoma
• Nausea and Vomiting
• Pain
• Psychological Impact of Cancer
• Sleep Disorder
• Sleep Wake Disorders
• Vomiting
• Weight Change

Intervention

Procedure:
• Quality-of-Life Assessment
Ancillary studies
• Yoga
Undergo a yoga-based rehabilitation program

Locations

Country	Name	City	State
United States	Albert Einstein College of Medicine	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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