Yoga in Relieving Fatigue in Patients Undergoing Chemotherapy for Ovarian Cancer
This study has been terminated.
(slow accrual)
Sponsor:
Comprehensive Cancer Center of Wake Forest University
Collaborator:
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT00856453
First received: March 4, 2009
Last updated: February 27, 2013
Last verified: July 2012
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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 Procedure: yoga classes |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label 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 Comprehensive Cancer Center of Wake Forest University:
Primary Outcome Measures:
- Self-reported fatigue [ Time Frame: 22 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Self-reported distress, depression, and sleep quality [ Time Frame: 22 weeks ] [ Designated as safety issue: No ]
- Pre- and post-yoga class change in symptom/distress ratings [ Time Frame: 22 weeks ] [ Designated as safety issue: No ]
- Yoga intervention adherence [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
| 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
Procedure: 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 and older |
| Genders 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
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
Comprehensive Cancer Center of Wake Forest University
Investigators
| Principal Investigator: | Suzanne C. Danhauer, PhD | Comprehensive Cancer Center of Wake Forest University |
| Principal Investigator: | Brigitte E. Miller, MD | Comprehensive Cancer Center of Wake Forest University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Comprehensive Cancer Center of Wake Forest University |
| ClinicalTrials.gov Identifier: | NCT00856453 History of Changes |
| Other Study ID Numbers: | CDR0000632845, CCCWFU-98408, IRB00007745 |
| Study First Received: | March 4, 2009 |
| Last Updated: | February 27, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Comprehensive Cancer Center of Wake Forest University:
|
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 Depressive Disorder Fatigue Ovarian Neoplasms Behavioral Symptoms Mood Disorders Mental Disorders Signs and 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 |
ClinicalTrials.gov processed this record on June 18, 2013