Fatigue Clinical Trial
Official title:
A Randomized Trial to Evaluate a Family-focused Mind Body Medicine Intervention to Reduce Fatigue Among Breast Cancer Survivors
NCT number | NCT00513136 |
Other study ID # | MMC2007-46 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | May 2007 |
Est. completion date | February 2009 |
Verified date | December 2019 |
Source | Mercy Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 36 |
Est. completion date | February 2009 |
Est. primary completion date | February 2009 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Mercy Medical Center | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Mercy Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fatigue | Change from baseline to end-of-intervention and 2 and 6 months post-intervention | ||
Secondary | Quality of Life; Mood; Social Support | Change from baseline to end-of-intervention and 2 and 6 months post intervention |
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