NCT00583739

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2007

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 31, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

December 4, 2008

Status Verified

December 1, 2008

Enrollment Period

1.2 years

First QC Date

December 20, 2007

Last Update Submit

December 3, 2008

Conditions

Breast Neoplasm

Keywords

FatigueYogaAnxietyQuality of Life

Outcome Measures

Primary Outcomes (1)

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

    8 weeks

Secondary Outcomes (1)

  • Analyze symptoms of depression and anxiety

    8 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Yoga intervention

Behavioral: Yoga

2

NO INTERVENTION

Control. No Yoga for 8 weeks.

Interventions

YogaBEHAVIORAL

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

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Iowa Hospitals & Clinics

Iowa City, Iowa, 52242, United States

Location

Related Publications (2)

  • 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.

    PMID: 16062164BACKGROUND

  • 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.

    PMID: 16374892BACKGROUND

MeSH Terms

Conditions

Breast NeoplasmsFatigueAnxiety Disorders

Interventions

Yoga

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Geraldine Jacobson, MD MPH

    department of radiation oncology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 20, 2007

First Posted

December 31, 2007

Study Start

August 1, 2007

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

December 4, 2008

Record last verified: 2008-12

Locations

US(1)