Clinical trial NCT00513136: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fatigue
Keywords: Fatigue
Breast Cancer
Behavioral Research
Quality of Life
Lead sponsor: Mercy Medical Center
Sponsor class: OTHER
First posted: 2007-08-08
Enrollment: 36
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Fatigue
timeFrame: Change from baseline to end-of-intervention and 2 and 6 months post-intervention
Secondary outcomes:
measure: Quality of Life; Mood; Social Support
timeFrame: Change from baseline to end-of-intervention and 2 and 6 months post intervention
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Mercy Medical Center
state: Maryland
Study officials:
affiliation: Mercy Medical Center
name: Kathy J Helzlsouer, MD, MHS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Maryland School of Social Work
name: Julianne Oktay, PhD, MSW
role: PRINCIPAL_INVESTIGATOR
References: