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Yoga to Reduce Cancer Fatigue

NCT ID: NCT00583739

Last Updated: 2008-12-04

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

PHASE2

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2008-10-31

Brief Summary

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A randomized trial from the British National Health Service found that supervised exercise benefits women with early stage breast cancer with improved functional and psychological benefit after a 12-week intervention and 6 months later. Considering the needs of breast cancer patients and survivors and the reported benefits of exercise and yoga intervention, the investigators propose a pilot study of an 8-week yoga intervention in breast cancer patients. This study would specifically address measures of fatigue and psychosocial distress in the population of breast cancer patients during treatment and within the year following treatment. Currently there is very limited literature on yoga intervention in this population.

Detailed Description

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Conditions

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Breast Neoplasm

Keywords

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Fatigue Yoga Anxiety Quality of Life

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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1

Yoga intervention

Group Type ACTIVE_COMPARATOR

Yoga

Intervention Type BEHAVIORAL

Gentle Yoga for breast cancer survivors, 1 time weekly, for 8 weeks.

2

Control. No Yoga for 8 weeks.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Yoga

Gentle Yoga for breast cancer survivors, 1 time weekly, for 8 weeks.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Potential subjects must have had histologically or cytologically confirmed breast cancer. This includes, but is not limited to: breast cancer-in situ; ductal carcinoma in situ; lobular carcinoma in situ; cystosarcoma phyllodes; inflammatory breast carcinoma; invasive breast carcinoma; and breast cancer not otherwise specified; cancer must be stage 0 through stage III.
* Treatment completion within the past calendar year.
* Age ≥ 18 years. While breast cancer can occur in the pediatric population, the pediatric population is best served by trials specifically designed for their age group.
* Life expectancy of greater than 1 year.
* Karnofsky ≥ 60%; see Appendix A.
* Women of childbearing potential are eligible for this study.
* Pregnant women are eligible for this study pending a doctor's note.
* The ability to understand and complete the study questionnaires.
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

* Patients who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
* Patients with known metastasis.
* Patients who are actively participating in a yoga class.
* Known uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would compromise subject health during yoga.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Iowa

OTHER

Sponsor Role lead

Responsible Party

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Department of Radiation Oncology

Principal Investigators

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Geraldine Jacobson, MD MPH

Role: PRINCIPAL_INVESTIGATOR

department of radiation oncology

Locations

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The University of Iowa Hospitals & Clinics

Iowa City, Iowa, United States

Site Status

Countries

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United States

References

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Bower JE, Woolery A, Sternlieb B, Garet D. Yoga for cancer patients and survivors. Cancer Control. 2005 Jul;12(3):165-71. doi: 10.1177/107327480501200304.

Reference Type BACKGROUND
PMID: 16062164 (View on PubMed)

Culos-Reed SN, Carlson LE, Daroux LM, Hately-Aldous S. A pilot study of yoga for breast cancer survivors: physical and psychological benefits. Psychooncology. 2006 Oct;15(10):891-7. doi: 10.1002/pon.1021.

Reference Type BACKGROUND
PMID: 16374892 (View on PubMed)

Other Identifiers

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200707733

Identifier Type: -

Identifier Source: org_study_id