NCT00856453

Brief Summary

RATIONALE: Yoga may decrease fatigue, distress, and depression, and improve sleep quality in patients undergoing chemotherapy for ovarian cancer. It is not yet known whether practicing yoga in group classes is more effective than practicing yoga at home. PURPOSE: This randomized clinical trial is studying how well yoga works in relieving fatigue in patients undergoing chemotherapy for ovarian cancer.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started May 2009

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

March 4, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 5, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

August 9, 2018

Status Verified

August 1, 2018

Enrollment Period

5 months

First QC Date

March 4, 2009

Last Update Submit

August 7, 2018

Conditions

DepressionFatigueOvarian Cancer

Keywords

fatiguedepressionrecurrent 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 (1)

  • Self-reported fatigue

    22 weeks

Secondary Outcomes (3)

  • Self-reported distress, depression, and sleep quality

    22 weeks

  • Pre- and post-yoga class change in symptom/distress ratings

    22 weeks

  • Yoga intervention adherence

    18 weeks

Study Arms (2)

Yoga classes plus home yoga practic

EXPERIMENTAL
Behavioral: Home yoga practiceBehavioral: yoga classes

home yoga practice alone

EXPERIMENTAL
Behavioral: Home yoga practice

Interventions

Home yoga practiceBEHAVIORAL

training for and tracking of patient's practice of yoga at home

Yoga classes plus home yoga practichome yoga practice alone
yoga classesBEHAVIORAL

organized out of home classes for yoga

Yoga classes plus home yoga practic

Eligibility Criteria

Age18 Years - 120 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of ovarian cancer * Any stage disease * Must be between 2-24 months post-primary treatment (surgery) following initial diagnosis and/or have a recurrence of ovarian cancer within the past 24 months (irrespective of current treatment status) * Began a new chemotherapy treatment regimen within the past 4 weeks or planning to begin new chemotherapy treatment regimen within the next 4 weeks PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Physically able to attend the intervention classes * Able to understand written and spoken English * Agree to keep psychiatric medications and doses stable during study intervention * No medical contraindications reported by the attending physician * No bipolar disorder, schizophrenia, psychotic depression, or any other psychotic disorder * No usage of illicit drugs PRIOR CONCURRENT THERAPY: * See Disease Characteristics * More than 3 months since prior yoga practice

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

MeSH Terms

Conditions

DepressionFatigueOvarian NeoplasmsCarcinoma, Ovarian Epithelial

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorSigns and SymptomsPathological Conditions, Signs and SymptomsEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian 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

Study Officials

  • Suzanne C. Danhauer, PhD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

  • Brigitte E. Miller, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2009

First Posted

March 5, 2009

Study Start

May 1, 2009

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

August 9, 2018

Record last verified: 2018-08

Locations

US(1)