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A Randomized Trial to Evaluate a Family-focused Mind Body Medicine Intervention to Reduce Fatigue Among Breast Cancer Survivors


Phase 3
N/A
N/A
Not Enrolling
Female
Fatigue

Thank you

Trial Information

A Randomized Trial to Evaluate a Family-focused Mind Body Medicine Intervention to Reduce Fatigue Among Breast Cancer Survivors


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Fatigue

Outcome Time Frame:

Change from baseline to end-of-intervention and 2 and 6 months post-intervention

Safety Issue:

No

Principal Investigator

Kathy J Helzlsouer, MD, MHS

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mercy Medical Center

Authority:

United States: Institutional Review Board

Study ID:

MMC2007-46

NCT ID:

NCT00513136

Start Date:

May 2007

Completion Date:

February 2009

Related Keywords:

  • Fatigue
  • Fatigue
  • Breast Cancer
  • Behavioral Research
  • Quality of Life
  • Breast Neoplasms
  • Fatigue

Name

Location

Mercy Medical CenterBaltimore, Maryland  21202