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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT00337233
First received: June 13, 2006
Last updated: September 29, 2014
Last verified: July 2013
  Purpose

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 Intervention
Breast Cancer
Fatigue
Ovarian Cancer
Psychosocial Effects of Cancer and Its Treatment
Procedure: yoga therapy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Restorative Yoga for Symptom Management and Stress Reduction in Women With Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by Comprehensive Cancer Center of Wake Forest University:

Primary Outcome Measures:
  • Fatigue as measured by the FACT-Fatigue subscale [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
  • Psychological distress as measured by the Center for Epidemiologic Studies-Depression Scale and the State-Trait Anxiety Inventory [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
  • Positive affect as measured by the Positive and Negative Affect Schedule [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 106
Study Start Date: January 2004
Estimated Study Completion Date: November 2016
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: yoga therapy
    10 week yoga class
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00337233

Locations
United States, North Carolina
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
Sponsors and Collaborators
Comprehensive Cancer Center of Wake Forest University
Investigators
Principal Investigator: Suzanne C. Danhauer, PhD Comprehensive Cancer Center of Wake Forest University
  More Information

Additional Information:
Publications:
Responsible Party: Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier: NCT00337233     History of Changes
Other Study ID Numbers: CDR0000481279, CCCWFU-02403, CCCWFU-BG03-658
Study First Received: June 13, 2006
Last Updated: September 29, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Comprehensive Cancer Center of Wake Forest University:
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

Additional relevant MeSH terms:
Breast Neoplasms
Fatigue
Ovarian Neoplasms
Adnexal Diseases
Breast Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Signs and Symptoms
Skin Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014