Clinical trial NCT00337233: Yoga in Controlling Symptoms and Reducing Stress in Women With Ovarian Cancer or Breast Cancer
Official title: Restorative Yoga for Symptom Management and Stress Reduction in Women With Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Fatigue
Ovarian Cancer
Psychosocial Effects of Cancer and Its Treatment
Keywords: 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
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-06-15
Enrollment: 106
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Fatigue as measured by the FACT-Fatigue subscale
timeFrame: 18 weeks
measure: Psychological distress as measured by the Center for Epidemiologic Studies-Depression Scale and the State-Trait Anxiety Inventory
timeFrame: 18 weeks
measure: Positive affect as measured by the Positive and Negative Affect Schedule
timeFrame: 18 weeks
measure: 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
timeFrame: 18 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Suzanne C. Danhauer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Danhauer SC, Mihalko SL, Russell GB, Campbell CR, Felder L, Daley K, Levine EA. Restorative yoga for women with breast cancer: findings from a randomized pilot study. Psychooncology. 2009 Apr;18(4):360-8. doi: 10.1002/pon.1503.