Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
36 participants
INTERVENTIONAL
2007-05-31
2009-02-28
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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I
10 week group-based mind body medicine intervention
Group based mind body medicine intervention
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
II
Group-based mind body medicine intervention with a family focus
Group-based mind body medicine intervention + family focus
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.
Interventions
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Group based mind body medicine intervention
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
Group-based mind body medicine intervention + family focus
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.
Eligibility Criteria
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Inclusion Criteria
* 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
FEMALE
No
Sponsors
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Mercy Medical Center
OTHER
Responsible Party
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Michael Mullen
Administration
Principal Investigators
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Kathy J Helzlsouer, MD, MHS
Role: PRINCIPAL_INVESTIGATOR
Mercy Medical Center
Julianne Oktay, PhD, MSW
Role: PRINCIPAL_INVESTIGATOR
University of Maryland School of Social Work
Locations
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Mercy Medical Center
Baltimore, Maryland, United States
Countries
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Other Identifiers
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MMC2007-46
Identifier Type: -
Identifier Source: org_study_id