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Fatigue Intervention Trial for Breast Cancer Survivors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kathy J. Helzlsouer, Mercy Medical Center
ClinicalTrials.gov Identifier:
NCT00513136
First received: August 7, 2007
Last updated: April 18, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Fatigue
 Behavioral: Group based mind body medicine intervention
Behavioral: Group-based mind body medicine intervention + family focus
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Trial to Evaluate a Family-focused Mind Body Medicine Intervention to Reduce Fatigue Among Breast Cancer Survivors

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mercy Medical Center:

Primary Outcome Measures:
  • Fatigue [ Time Frame: Change from baseline to end-of-intervention and 2 and 6 months post-intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of Life; Mood; Social Support [ Time Frame: Change from baseline to end-of-intervention and 2 and 6 months post intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: May 2007
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: I
10 week group-based mind body medicine intervention
 Behavioral: Group based mind body medicine intervention
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
Experimental: II
Group-based mind body medicine intervention with a family focus
 Behavioral: Group-based mind body medicine intervention + family focus
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.

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

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00513136

Locations
United States, Maryland
Mercy Medical Center
Baltimore, Maryland, United States, 21093
Sponsors and Collaborators
Mercy Medical Center
Investigators
Principal Investigator: Kathy J Helzlsouer, MD, MHS Mercy Medical Center
Principal Investigator: Julianne Oktay, PhD, MSW University of Maryland School of Social Work
  More Information

No publications provided

Responsible Party: Kathy J. Helzlsouer, Director, Prevention and Research Center, Mercy Medical Center
ClinicalTrials.gov Identifier: NCT00513136     History of Changes
Other Study ID Numbers: MMC2007-46
Study First Received: August 7, 2007
Last Updated: April 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mercy Medical Center:
Fatigue
Breast Cancer
Behavioral Research
Quality of Life

Additional relevant MeSH terms:
Breast Neoplasms
Fatigue
Neoplasms by Site
Neoplasms
 Breast Diseases
Skin Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013