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

NCT ID: NCT00179348

Last Updated: 2023-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

399 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-02-08

Study Completion Date

2016-07-20

Brief Summary

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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

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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.

Conditions

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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 Type EXPERIMENTAL

Quality-of-Life Assessment

Intervention Type PROCEDURE

Ancillary studies

Yoga

Intervention Type PROCEDURE

Undergo a yoga-based rehabilitation program

Group II (standard care/control)

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

Group Type ACTIVE_COMPARATOR

Quality-of-Life Assessment

Intervention Type PROCEDURE

Ancillary studies

Yoga

Intervention Type PROCEDURE

Undergo a yoga-based rehabilitation program

Interventions

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Quality-of-Life Assessment

Ancillary studies

Intervention Type PROCEDURE

Yoga

Undergo a yoga-based rehabilitation program

Intervention Type PROCEDURE

Other Intervention Names

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Quality of Life Assessment Yoga Therapy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Albert Einstein College of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alyson Moadel

Role: PRINCIPAL_INVESTIGATOR

Albert Einstein College of Medicine

Locations

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Albert Einstein College of Medicine

The Bronx, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 17785709 (View on PubMed)

Other Identifiers

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NCI-2014-01579

Identifier Type: REGISTRY

Identifier Source: secondary_id

2000-007

Identifier Type: -

Identifier Source: secondary_id

NCI R03 CA88598-01A1

Identifier Type: -

Identifier Source: secondary_id

01-02-038

Identifier Type: -

Identifier Source: secondary_id

CCI# 00-7

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA013330

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R03CA088598

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000-007

Identifier Type: -

Identifier Source: org_study_id

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