Yoga in Controlling Symptoms and Reducing Stress in Women With Ovarian Cancer or Breast Cancer

Sponsor

Wake Forest University Health Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT00337233

Collaborator

National Cancer Institute (NCI) (NIH)

106

Enrollment

Location

154

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Fatigue Ovarian Cancer Psychosocial Effects of Cancer and Its Treatment	Procedure: yoga therapy	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

106 participants

Allocation:

N/A

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 :

Jan 1, 2004

Actual Primary Completion Date :

Nov 1, 2006

Actual Study Completion Date :

Nov 1, 2016

Outcome Measures

Primary Outcome Measures

Fatigue as measured by the FACT-Fatigue subscale [18 weeks]
Psychological distress as measured by the Center for Epidemiologic Studies-Depression Scale and the State-Trait Anxiety Inventory [18 weeks]
Positive affect as measured by the Positive and Negative Affect Schedule [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 [18 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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