Fatigue Intervention Trial for Breast Cancer Survivors

Phase 3

Completed

• Conditions: Fatigue
• Interventions: Behavioral: Group-based mind body medicine intervention + family focus; Behavioral: Group based mind body medicine intervention

• Registration Number: NCT00513136
• Lead Sponsor: Mercy Medical Center

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.

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-08-07
• Study First Submitted QC: 2007-08-07
• Study First Posted: 2007-08-08
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-11
• Last Update Posted: 2019-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
II	Group-based mind body medicine intervention + family focus	Group-based mind body medicine intervention with a family focus
I	Group based mind body medicine intervention	10 week group-based mind body medicine intervention

Primary Outcome Measures

Name	Time	Method
Fatigue	Change from baseline to end-of-intervention and 2 and 6 months post-intervention

Secondary Outcome Measures

Name	Time	Method
Quality of Life; Mood; Social Support	Change from baseline to end-of-intervention and 2 and 6 months post intervention

Trial Locations

Locations (1)

Mercy Medical Center; 🇺🇸 Baltimore, Maryland, United States