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

Primary Purpose

Breast Cancer, Fatigue, Ovarian Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
yoga therapy
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring 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

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)FemaleDoes not accept 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 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

Sites / Locations

  • Wake Forest University Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 13, 2006
Last Updated
May 25, 2017
Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00337233
Brief Title
Yoga in Controlling Symptoms and Reducing Stress in Women With Ovarian Cancer or Breast Cancer
Official Title
Restorative Yoga for Symptom Management and Stress Reduction in Women With Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Fatigue, Ovarian Cancer, Psychosocial Effects of Cancer and Its Treatment
Keywords
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
yoga therapy
Intervention Description
10 week yoga class
Primary Outcome Measure Information:
Title
Fatigue as measured by the FACT-Fatigue subscale
Time Frame
18 weeks
Title
Psychological distress as measured by the Center for Epidemiologic Studies-Depression Scale and the State-Trait Anxiety Inventory
Time Frame
18 weeks
Title
Positive affect as measured by the Positive and Negative Affect Schedule
Time Frame
18 weeks
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanne C. Danhauer, PhD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Comprehensive Cancer Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1096
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19242916
Citation
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.
Results Reference
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Yoga in Controlling Symptoms and Reducing Stress in Women With Ovarian Cancer or Breast Cancer

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