This trial is active, not recruiting.

Conditions breast cancer, fatigue, ovarian cancer, psychosocial effects of cancer and its treatment
Treatment yoga therapy
Sponsor Comprehensive Cancer Center of Wake Forest University
Collaborator National Cancer Institute (NCI)
Start date January 2004
End date November 2006
Trial size 106 participants
Trial identifier NCT00337233, CCCWFU-02403, CCCWFU-BG03-658, CDR0000481279


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose supportive care

Primary Outcomes

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

Eligibility Criteria

Female participants at least 18 years old.

DISEASE CHARACTERISTICS: - Diagnosis of breast or ovarian cancer - Must be 2-24 months post-primary treatment (e.g., surgery) for breast cancer and/or have had a recurrence of breast cancer within the past 24 months - Must be 3-24 months post-primary treatment (e.g., surgery) for ovarian cancer and/or have had a recurrence of ovarian cancer within the past 24 months - Hormone receptor status not specified PATIENT CHARACTERISTICS: - Female - Menopausal status not specified - Zubrod performance status 0-3 - No medical contraindications - Understands written and spoken English PRIOR CONCURRENT THERAPY: - See Disease Characteristics

Additional Information

Official title Restorative Yoga for Symptom Management and Stress Reduction in Women With Ovarian Cancer
Principal investigator Suzanne C. Danhauer, PhD
Description OBJECTIVES: - 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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2014.
Information provided to ClinicalTrials.gov by Comprehensive Cancer Center of Wake Forest University.