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Yoga in Relieving Fatigue in Patients Undergoing Chemotherapy for Ovarian Cancer

Primary Purpose

Depression, Fatigue, Ovarian Cancer

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Home yoga practice
yoga classes
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Depression focused on measuring fatigue, depression, recurrent ovarian epithelial cancer, recurrent ovarian germ cell tumor, stage I ovarian epithelial cancer, stage I ovarian germ cell tumor, stage II ovarian epithelial cancer, stage II ovarian germ cell tumor, stage III ovarian epithelial cancer, stage III ovarian germ cell tumor, stage IV ovarian epithelial cancer, stage IV ovarian germ cell tumor

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Wake Forest University Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Yoga classes plus home yoga practic

home yoga practice alone

Arm Description

Outcomes

Primary Outcome Measures

Self-reported fatigue

Secondary Outcome Measures

Self-reported distress, depression, and sleep quality
Pre- and post-yoga class change in symptom/distress ratings
Yoga intervention adherence

Full Information

First Posted
March 4, 2009
Last Updated
August 7, 2018
Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00856453
Brief Title
Yoga in Relieving Fatigue in Patients Undergoing Chemotherapy for Ovarian Cancer
Official Title
Restorative Yoga for Women With Ovarian Cancer Undergoing Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Why Stopped
slow accrual
Study Start Date
May 2009 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
OBJECTIVES: Primary Examine the effectiveness of a restorative yoga (RY) intervention vs home yoga practice in patients undergoing chemotherapy for ovarian cancer. Secondary Examine the effectiveness of RY vs home yoga practice on depression, distress, and sleep quality in these patients. Examine the acute (pre- and post-yoga class) effects in these patients. Test the feasibility of using behavioral strategies to enhance yoga intervention adherence. OUTLINE: Patients are randomized to 1 of 2 arms. Arm I (restorative yoga intervention): Patients attend 45-minute group yoga classes every 3 weeks on the days they are scheduled for chemotherapy for approximately 5-6 sessions. Patients are provided with a yoga DVD, a manual with photos and written descriptions/guidance to practice yoga postures at home, and basic yoga equipment (yoga mat, strap, block, yoga blankets) and instructed to practice to the DVD 3 times per week (twice weekly during week of group yoga class) for ≥ 45 minutes. Patients record yoga practice time/activity at the third yoga session of each week. Arm II (home yoga practice): Patients are provided with a yoga DVD, a manual with photos and written descriptions/guidance to practice yoga postures at home, and basic yoga equipment (yoga mat, strap, block, yoga blankets) and instructed to practice to the DVD 3 times per week for ≥ 45 minutes. Patients record yoga practice time/activity at the third yoga session of each week. All patients complete questionnaires at baseline, at weeks 9, 18, and 22. Self-report measures include Distress Thermometer, Positive and Negative Affect Schedule, Center for Epidemiologic Studies-Depression Scale, M.D. Anderson Symptom Inventory, Functional Assessment of Cancer Therapy - Ovarian, Functional Assessment of Chronic Illness Therapy (FACIT) - Spiritual Subscale, FACIT- Fatigue Subscale, State-Trait Anxiety Inventory, Women's Health Initiative Insomnia Rating Scale, Medical Outcome Study-Social Support Survey, Integrative Medicine Use, Pre- and Post- Class Ratings, and Intervention Feedback . After completion of study, patients are followed at 4 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Fatigue, Ovarian Cancer
Keywords
fatigue, depression, recurrent ovarian epithelial cancer, recurrent ovarian germ cell tumor, stage I ovarian epithelial cancer, stage I ovarian germ cell tumor, stage II ovarian epithelial cancer, stage II ovarian germ cell tumor, stage III ovarian epithelial cancer, stage III ovarian germ cell tumor, stage IV ovarian epithelial cancer, stage IV ovarian germ cell tumor

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Yoga classes plus home yoga practic
Arm Type
Experimental
Arm Title
home yoga practice alone
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Home yoga practice
Intervention Description
training for and tracking of patient's practice of yoga at home
Intervention Type
Behavioral
Intervention Name(s)
yoga classes
Intervention Description
organized out of home classes for yoga
Primary Outcome Measure Information:
Title
Self-reported fatigue
Time Frame
22 weeks
Secondary Outcome Measure Information:
Title
Self-reported distress, depression, and sleep quality
Time Frame
22 weeks
Title
Pre- and post-yoga class change in symptom/distress ratings
Time Frame
22 weeks
Title
Yoga intervention adherence
Time Frame
18 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanne C. Danhauer, PhD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Brigitte E. Miller, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Comprehensive Cancer Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1096
Country
United States

12. IPD Sharing Statement

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Yoga in Relieving Fatigue in Patients Undergoing Chemotherapy for Ovarian Cancer

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