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Completed

NCT Number: NCT00513136

Fatigue Intervention Trial for Breast Cancer Survivors

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.

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Key information

Conditions

Fatigue Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Mercy Medical Center

Baltimore, Maryland, 21093, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group based mind body medicine intervention

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Fatigue

    Time frame: Change from baseline to end-of-intervention and 2 and 6 months post-intervention

Secondary outcomes

  1. Quality of Life; Mood; Social Support

    Time frame: Change from baseline to end-of-intervention and 2 and 6 months post intervention

Sponsors and collaborators

Lead sponsor

Mercy Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Aug 8, 2007
Registry last updated
Dec 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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