Fatigue Intervention Trial for Breast Cancer Survivors
Primary Purpose
Fatigue
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Group based mind body medicine intervention
Group-based mind body medicine intervention + family focus
Sponsored by

About this trial
This is an interventional treatment trial for Fatigue focused on measuring Fatigue, Breast Cancer, Behavioral Research, Quality of Life
Eligibility Criteria
Inclusion Criteria:
- Stage I-III Breast Cancer
- At least 3 months since last breast cancer treatment (excluding hormonal therapy or Herceptin).
- 4 week history of persistent moderate to severe fatigue
- Competent to sign informed consent
- Willing to be randomized
Exclusion Criteria:
- Metastatic breast cancer
Sites / Locations
- Mercy Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
I
II
Arm Description
10 week group-based mind body medicine intervention
Group-based mind body medicine intervention with a family focus
Outcomes
Primary Outcome Measures
Fatigue
Secondary Outcome Measures
Quality of Life; Mood; Social Support
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00513136
Brief Title
Fatigue Intervention Trial for Breast Cancer Survivors
Official Title
A Randomized Trial to Evaluate a Family-focused Mind Body Medicine Intervention to Reduce Fatigue Among Breast Cancer Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mercy Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Thirty to forty percent of breast cancer survivors suffer from persistent fatigue lingering months to years after adjuvant therapy is completed. Although researchers have developed some effective interventions (exercise or group-based holistic program) to treat fatigue, none have addressed the role of the family in the patient's long-term recovery.
The investigators hypothesize that a family-focused intervention in combination with a mind-body group intervention will be more effective in reducing fatigue, improving quality of life, and enhancing family relationships for breast cancer survivors than a group intervention with an individual focus.
Detailed Description
We propose to address the persistent fatigue experienced by brest cancer survivors by using a 10 week group-based mind body medicine intervention that includes the family in the process. We believe that this family-centered approach can facilitate better communication, create shared illness experience and relieve conflict. Reducing this pervasive source of stress will not only reduce the survivor's fatigue, but also foster an opposite family dynamic with positive effects in many other aspects of post-treatment recovery. We will compare the effectiveness of a 10 week group intervention to a 10 week group intervention that includes a family focus.
Breast cancer survivors with moderate to severe fatigue will be randomly assigned to one of the two groups and we will measure change in fatigue, quality of life, mood and social support from baseline to end-of-program and then two and six months after program completion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue
Keywords
Fatigue, Breast Cancer, Behavioral Research, Quality of Life
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
I
Arm Type
Active Comparator
Arm Description
10 week group-based mind body medicine intervention
Arm Title
II
Arm Type
Experimental
Arm Description
Group-based mind body medicine intervention with a family focus
Intervention Type
Behavioral
Intervention Name(s)
Group based mind body medicine intervention
Intervention Description
Small groups of women (5-15) will participate in 10 weekly sessions that will include learning relaxation and yoga techniques, principles of exercise and nutrition, cognitive behavioral therapy and exploration of common issues and concerns
Intervention Type
Behavioral
Intervention Name(s)
Group-based mind body medicine intervention + family focus
Intervention Description
In addition to the 10 weekly group-based sessions, women and their key family members will meet twice with a cognitive therapist and family members will participate in selected aspects of the 10 week program.
Primary Outcome Measure Information:
Title
Fatigue
Time Frame
Change from baseline to end-of-intervention and 2 and 6 months post-intervention
Secondary Outcome Measure Information:
Title
Quality of Life; Mood; Social Support
Time Frame
Change from baseline to end-of-intervention and 2 and 6 months post intervention
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Stage I-III Breast Cancer
At least 3 months since last breast cancer treatment (excluding hormonal therapy or Herceptin).
4 week history of persistent moderate to severe fatigue
Competent to sign informed consent
Willing to be randomized
Exclusion Criteria:
Metastatic breast cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathy J Helzlsouer, MD, MHS
Organizational Affiliation
Mercy Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Julianne Oktay, PhD, MSW
Organizational Affiliation
University of Maryland School of Social Work
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mercy Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21093
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Fatigue Intervention Trial for Breast Cancer Survivors
We'll reach out to this number within 24 hrs