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

Breast Cancer Clinical Trial

Official title:

Restorative Yoga for Symptom Management and Stress Reduction in Women With Ovarian Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00337233
• Other study ID #: CDR0000481279
• Secondary ID: CCCWFU-02403CCCW
• Status: Completed
• Phase: N/A
• First received: June 13, 2006
• Last updated: May 25, 2017
• Start date: January 2004
• Est. completion date: November 2016

Study information

• Verified date: September 2015
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: November 2016
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Fatigue
• Ovarian Cancer
• Ovarian Neoplasms
• Psychosocial Effects of Cancer and Its Treatment

Intervention

Procedure:
• yoga therapy
10 week yoga class

Locations

Country	Name	City	State
United States	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue as measured by the FACT-Fatigue subscale		18 weeks
Primary	Psychological distress as measured by the Center for Epidemiologic Studies-Depression Scale and the State-Trait Anxiety Inventory		18 weeks
Primary	Positive affect as measured by the Positive and Negative Affect Schedule		18 weeks
Primary	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