Fatigue Intervention Trial for Breast Cancer Survivors

Fatigue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00513136
• Other study ID #: MMC2007-46
• Status: Completed
• Phase: Phase 3
• Start date: May 2007
• Est. completion date: February 2009

Study information

• Verified date: December 2019
• Source: Mercy Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Fatigue

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
• 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.

Locations

Country	Name	City	State
United States	Mercy Medical Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Mercy Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue		Change from baseline to end-of-intervention and 2 and 6 months post-intervention
Secondary	Quality of Life; Mood; Social Support		Change from baseline to end-of-intervention and 2 and 6 months post intervention