NCT00337233

Brief Summary

RATIONALE: Yoga may improve symptoms and quality of life and reduce stress in patients with ovarian cancer or breast cancer and may help them live more comfortably. PURPOSE: This clinical trial is studying how well yoga works in controlling symptoms and reducing stress in women with ovarian cancer or breast cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Jan 2004

Longer than P75 for not_applicable breast-cancer

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

January 1, 2004

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

June 13, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 15, 2006

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
10 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

May 30, 2017

Status Verified

September 1, 2015

Enrollment Period

2.8 years

First QC Date

June 13, 2006

Last Update Submit

May 25, 2017

Conditions

Breast CancerFatigueOvarian CancerPsychosocial Effects of Cancer and Its Treatment

Keywords

fatiguepsychosocial effects of cancer and its treatmentrecurrent breast cancerstage I breast cancerstage II breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancerstage IV breast cancerrecurrent ovarian epithelial cancerrecurrent ovarian germ cell tumorstage I ovarian epithelial cancerstage I ovarian germ cell tumorstage II ovarian epithelial cancerstage II ovarian germ cell tumorstage III ovarian epithelial cancerstage III ovarian germ cell tumorstage IV ovarian epithelial cancerstage IV ovarian germ cell tumor

Outcome Measures

Primary Outcomes (4)

  • Fatigue as measured by the FACT-Fatigue subscale

    18 weeks

  • Psychological distress as measured by the Center for Epidemiologic Studies-Depression Scale and the State-Trait Anxiety Inventory

    18 weeks

  • Positive affect as measured by the Positive and Negative Affect Schedule

    18 weeks

  • Quality of life as measured by Functional Assessment of Cancer Therapy (FACT-O) for patients with ovarian cancer or FACT-B for patients with breast cancer

    18 weeks

Interventions

yoga therapyPROCEDURE

10 week yoga class

Eligibility Criteria

Age18 Years - 120 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of breast or ovarian cancer * Must be 2-24 months post-primary treatment (e.g., surgery) for breast cancer and/or have had a recurrence of breast cancer within the past 24 months * Must be 3-24 months post-primary treatment (e.g., surgery) for ovarian cancer and/or have had a recurrence of ovarian cancer within the past 24 months * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Female * Menopausal status not specified * Zubrod performance status 0-3 * No medical contraindications * Understands written and spoken English PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

Related Publications (1)

  • Danhauer SC, Mihalko SL, Russell GB, Campbell CR, Felder L, Daley K, Levine EA. Restorative yoga for women with breast cancer: findings from a randomized pilot study. Psychooncology. 2009 Apr;18(4):360-8. doi: 10.1002/pon.1503.

    PMID: 19242916RESULT

MeSH Terms

Conditions

Breast NeoplasmsFatigueOvarian NeoplasmsCarcinoma, Ovarian Epithelial

Interventions

Yoga

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Suzanne C. Danhauer, PhD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2006

First Posted

June 15, 2006

Study Start

January 1, 2004

Primary Completion

November 1, 2006

Study Completion

November 1, 2016

Last Updated

May 30, 2017

Record last verified: 2015-09

Locations

US(1)