Fatigue Intervention Trial for Breast Cancer Survivors

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Fatigue

Intervention / Treatment
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* Behavioral: Group based mind body medicine intervention
* Behavioral: Group-based mind body medicine intervention + family focus


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: I<br>10 week group-based mind body medicine intervention | Behavioral: Group based mind body medicine intervention<br>* 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<br>|
| Experimental: II<br>Group-based mind body medicine intervention with a family focus | Behavioral: Group-based mind body medicine intervention + family focus<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue |  | Change from baseline to end-of-intervention and 2 and 6 months post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life; Mood; Social Support |  | Change from baseline to end-of-intervention and 2 and 6 months post intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fatigue, Breast Cancer, Behavioral Research, Quality of Life