Trial Information
Restorative Yoga for Symptom Management and Stress Reduction in Women With Ovarian Cancer
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Fatigue as measured by the FACT-Fatigue subscale
Outcome Time Frame:
18 weeks
Safety Issue:
No
Principal Investigator
Suzanne C. Danhauer, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Comprehensive Cancer Center of Wake Forest University
Authority:
United States: Institutional Review Board
Study ID:
CDR0000481279
NCT ID:
NCT00337233
Start Date:
January 2004
Completion Date:
Related Keywords:
- Breast Cancer
- Fatigue
- Ovarian Cancer
- Psychosocial Effects of Cancer and Its Treatment
- fatigue
- psychosocial effects of cancer and its treatment
- recurrent breast cancer
- stage I breast cancer
- stage II breast cancer
- stage IIIA breast cancer
- stage IIIB breast cancer
- stage IIIC breast cancer
- stage IV breast cancer
- 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
- Breast Neoplasms
- Fatigue
- Ovarian Neoplasms
Name | Location |
Wake Forest University Comprehensive Cancer Center |
Winston-Salem, North Carolina 27157-1096 |