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Yoga to Reduce Cancer Fatigue

Primary Purpose

Breast Neoplasm

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Yoga

About this trial

This is an interventional supportive care trial for Breast Neoplasm focused on measuring Fatigue, Yoga, Anxiety, Quality of Life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

The University of Iowa Hospitals & Clinics

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Arm Description

Yoga intervention

Control. No Yoga for 8 weeks.

Outcomes

Primary Outcome Measures

Determine if an 8 week yoga program designed for breast cancer patients improves subjective reports of overall well being and fatigue

Secondary Outcome Measures

Analyze symptoms of depression and anxiety

Full Information

NCT ID

NCT00583739

First Posted

December 20, 2007

Last Updated

December 3, 2008

Sponsor

University of Iowa

1. Study Identification

Unique Protocol Identification Number

NCT00583739

Brief Title

Yoga to Reduce Cancer Fatigue

Official Title

Effect of a Yoga Intervention on Fatigue, Distress, and Quality of Life in Breast Cancer Patients: A Randomized Pilot Study

Study Type

Interventional

2. Study Status

Record Verification Date

December 2008

Overall Recruitment Status

Completed

Study Start Date

August 2007 (undefined)

Primary Completion Date

October 2008 (Actual)

Study Completion Date

October 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Iowa

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Neoplasm

Keywords

Fatigue, Yoga, Anxiety, Quality of Life

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Yoga intervention

Arm Title

Arm Type

No Intervention

Arm Description

Control. No Yoga for 8 weeks.

Intervention Type

Behavioral

Intervention Name(s)

Yoga

Intervention Description

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

Primary Outcome Measure Information:

Title

Determine if an 8 week yoga program designed for breast cancer patients improves subjective reports of overall well being and fatigue

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Analyze symptoms of depression and anxiety

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Geraldine Jacobson, MD MPH

Organizational Affiliation

department of radiation oncology

Official's Role

Principal Investigator

Facility Information:

Facility Name

The University of Iowa Hospitals & Clinics

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

16062164

Citation

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.

Results Reference

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PubMed Identifier

16374892

Citation

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.

Results Reference

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Yoga to Reduce Cancer Fatigue

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