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Yoga in Relieving Fatigue in Patients Undergoing Chemotherapy for Ovarian Cancer

This study has been terminated.
(slow accrual)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT00856453
First received: March 4, 2009
Last updated: May 25, 2017
Last verified: July 2012
  Purpose

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.


Condition Intervention
Depression Fatigue Ovarian Cancer Behavioral: Home yoga practice Behavioral: yoga classes

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Supportive Care
Official Title: Restorative Yoga for Women With Ovarian Cancer Undergoing Chemotherapy

Resource links provided by NLM:


Further study details as provided by Wake Forest University Health Sciences:

Primary Outcome Measures:
  • Self-reported fatigue [ Time Frame: 22 weeks ]

Secondary Outcome Measures:
  • Self-reported distress, depression, and sleep quality [ Time Frame: 22 weeks ]
  • Pre- and post-yoga class change in symptom/distress ratings [ Time Frame: 22 weeks ]
  • Yoga intervention adherence [ Time Frame: 18 weeks ]

Enrollment: 2
Study Start Date: May 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Yoga classes plus home yoga practic Behavioral: Home yoga practice
training for and tracking of patient's practice of yoga at home
Behavioral: yoga classes
organized out of home classes for yoga
Experimental: home yoga practice alone Behavioral: Home yoga practice
training for and tracking of patient's practice of yoga at home

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.

  Eligibility

Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00856453

Locations
United States, North Carolina
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Investigators
Principal Investigator: Suzanne C. Danhauer, PhD Wake Forest University Health Sciences
Principal Investigator: Brigitte E. Miller, MD Wake Forest University Health Sciences
  More Information

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00856453     History of Changes
Other Study ID Numbers: CDR0000632845
CCCWFU-98408
IRB00007745
Study First Received: March 4, 2009
Last Updated: May 25, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wake Forest University Health Sciences:
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

Additional relevant MeSH terms:
Depression
Ovarian Neoplasms
Fatigue
Behavioral Symptoms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Signs and Symptoms

ClinicalTrials.gov processed this record on June 23, 2017