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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT00337233
First received: June 13, 2006
Last updated: April 4, 2017
Last verified: September 2015
  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: No masking
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 Wake Forest University Health Sciences:

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

Enrollment: 106
Study Start Date: January 2004
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 to 120 Years   (Adult, Senior)
Sexes 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
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Investigators
Principal Investigator: Suzanne C. Danhauer, PhD Wake Forest University Health Sciences
  More Information

Publications:
Responsible Party: Wake Forest University Health Sciences
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: April 4, 2017

Keywords provided by Wake Forest University Health Sciences:
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
Ovarian Neoplasms
Fatigue
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Signs and Symptoms

ClinicalTrials.gov processed this record on May 25, 2017