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

May 25, 2017 updated by: Wake Forest University Health Sciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

106

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157-1096
        • Wake Forest University Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (ACTUAL)

November 1, 2006

Study Completion (ACTUAL)

November 1, 2016

Study Registration Dates

First Submitted

June 13, 2006

First Submitted That Met QC Criteria

June 13, 2006

First Posted (ESTIMATE)

June 15, 2006

Study Record Updates

Last Update Posted (ACTUAL)

May 30, 2017

Last Update Submitted That Met QC Criteria

May 25, 2017

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000481279
  • CCCWFU-02403
  • CCCWFU-BG03-658

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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