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Fatigue Intervention Trial for Breast Cancer Survivors

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ClinicalTrials.gov Identifier: NCT00513136
Recruitment Status : Completed
First Posted : August 8, 2007
Last Update Posted : April 19, 2012
Information provided by (Responsible Party):

Study Description
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.

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

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : May 2007
Primary Completion Date : February 2009
Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :
  1. Fatigue [ Time Frame: Change from baseline to end-of-intervention and 2 and 6 months post-intervention ]

Secondary Outcome Measures :
  1. Quality of Life; Mood; Social Support [ Time Frame: Change from baseline to end-of-intervention and 2 and 6 months post intervention ]

Eligibility Criteria

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00513136

United States, Maryland
Mercy Medical Center
Baltimore, Maryland, United States, 21093
Sponsors and Collaborators
Mercy Medical Center
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

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
First Posted: August 8, 2007    Key Record Dates
Last Update Posted: April 19, 2012
Last Verified: April 2012

Keywords provided by Kathy J. Helzlsouer, Mercy Medical Center:
Breast Cancer
Behavioral Research
Quality of Life

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