Yoga in Controlling Symptoms and Reducing Stress in Women With Ovarian Cancer or Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00337233|
Recruitment Status : Completed
First Posted : June 15, 2006
Last Update Posted : May 30, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Fatigue Ovarian Cancer Psychosocial Effects of Cancer and Its Treatment||Procedure: yoga therapy||Not Applicable|
- Determine the feasibility of implementing a restorative yoga intervention as a complementary supportive therapy for women with ovarian or breast cancer.
- Measure changes in fatigue, psychosocial distress (anxiety, depression), psychological well-being (positive emotions), and overall quality of life from baseline to completion of the study treatment.
OUTLINE: This is a pilot study.
Patients undergo a 75-minute restorative yoga session once a week for 10 weeks.
Patients complete questionnaires regarding fatigue, psychological distress (anxiety, depression), positive affect, and quality of life at baseline, immediately after the final yoga session, and then at 2 months after the final yoga session.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||106 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Restorative Yoga for Symptom Management and Stress Reduction in Women With Ovarian Cancer|
|Study Start Date :||January 2004|
|Actual Primary Completion Date :||November 2006|
|Actual Study Completion Date :||November 2016|
Procedure: yoga therapy
- Fatigue as measured by the FACT-Fatigue subscale [ Time Frame: 18 weeks ]
- Psychological distress as measured by the Center for Epidemiologic Studies-Depression Scale and the State-Trait Anxiety Inventory [ Time Frame: 18 weeks ]
- Positive affect as measured by the Positive and Negative Affect Schedule [ Time Frame: 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 [ Time Frame: 18 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00337233
|United States, North Carolina|
|Wake Forest University Comprehensive Cancer Center|
|Winston-Salem, North Carolina, United States, 27157-1096|
|Principal Investigator:||Suzanne C. Danhauer, PhD||Wake Forest University Health Sciences|