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

Albert Einstein College of Medicine

Status: Completed

Conditions: Colorectal Carcinoma; Nausea and Vomiting; Psychological Impact of Cancer; Lung Carcinoma; Fatigue; Anxiety; Cognitive Side Effects of Cancer Therapy; Weight Change; Alopecia; Sleep Disorder; Depression; Breast Carcinoma; Pain

Treatments: Procedure: Quality-of-Life Assessment; Procedure: Yoga

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00179348

P30CA013330 (U.S. NIH Grant/Contract)

2000-007

CCI# 00-7 (Other Identifier)

NCI-2014-01579 (Registry Identifier)

NCI R03 CA88598-01A1

R03CA088598 (U.S. NIH Grant/Contract)

01-02-038

Details and patient eligibility

About

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.

Full 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.

Enrollment: 399 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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399 participants in 2 patient groups

Group I (yoga-based rehabilitation program)

Experimental group

Description:

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.

Treatment:

Procedure: Yoga

Procedure: Quality-of-Life Assessment

Group II (standard care/control)

Active Comparator group

Description:

After a 3 month wait period, participants undergo a yoga-based rehabilitation program as in Group I.

Treatment:

Procedure: Yoga

Procedure: Quality-of-Life Assessment