Clinical trial NCT00179348: Yoga-Based Rehabilitation Program in Reducing Physical and Emotional Side Effects in Patients With Cancer
Official title: Evaluation of a Yoga-Based Cancer Rehabilitation Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2005-09-16
Enrollment: 399
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in Functional Assessment of Cancer Therapy summary score (physical, emotional, spiritual, and social QOL)
timeFrame: Baseline to up to 6 months
measure: Program compliance as measured by Yoga - Daily Practice Calendar and Yoga Class Attendance Record and Yoga Evaluation Form
timeFrame: Up to 6 months
measure: Program satisfaction measured by Yoga - Daily Practice Calendar and Yoga Class Attendance Record and Yoga Evaluation Form
timeFrame: Up to 6 months
Secondary outcomes:
measure: Pain
timeFrame: Baseline to up to 6 months
measure: Mood
timeFrame: Baseline to up to 6 months
measure: spiritual well-being
timeFrame: Baseline to up to 6 months
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Albert Einstein College of Medicine
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Alyson Moadel
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.