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NCT Number: NCT00179348

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

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.

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Key information

Conditions

Alopecia Anxiety Anxiety Disorders Behavior Behavioral Symptoms Body Weight Body Weight Changes Breast Carcinoma Breast Diseases Breast Neoplasms Cognitive Side Effects of Cancer Therapy Colonic Diseases Colorectal Carcinoma Colorectal Neoplasms Depression Digestive System Diseases Digestive System Neoplasms Fatigue Gastrointestinal Diseases Gastrointestinal Neoplasms Hair Diseases Hypotrichosis Intestinal Diseases Intestinal Neoplasms Lung Carcinoma Lung Diseases Lung Neoplasms Mental Disorders Nausea Nausea and Vomiting Neoplasms Neoplasms by Site Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Psychological Impact of Cancer Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Signs and Symptoms Signs and Symptoms, Digestive Skin Diseases Skin and Connective Tissue Diseases Sleep Disorder Sleep Wake Disorders Thoracic Neoplasms Vomiting Weight Change

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

quality-of-life assessment

Procedure

Ancillary studies

Other names: Quality of Life Assessment

Yoga

Procedure

Undergo a yoga-based rehabilitation program

Other names: Yoga Therapy

Primary outcomes

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

    Time frame: 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.

  2. Program compliance as measured by Yoga - Daily Practice Calendar and Yoga Class Attendance Record and Yoga Evaluation Form

    Time frame: 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.

  3. Program satisfaction measured by Yoga - Daily Practice Calendar and Yoga Class Attendance Record and Yoga Evaluation Form

    Time frame: 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 outcomes

  1. Pain

    Time frame: 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.

  2. Mood

    Time frame: 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.

  3. spiritual well-being

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Albert Einstein College of Medicine

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Evaluation of a Yoga-Based Cancer Rehabilitation Program

Important dates

Study start
2001
Primary completion
2016
Study completion
2016
First posted
Sep 16, 2005
Registry last updated
May 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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