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Effects of MBSR in Early Stage Breast Cancer Recovery

21 Years
Not Enrolling
Breast Cancer

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Trial Information

Effects of MBSR in Early Stage Breast Cancer Recovery

Breast cancer is the most common cancer among women in the U.S. - about 1 in 8 women will
develop the disease in their lifetime. Although tremendous strides have been made in its
treatment, more than 40,000 deaths will be attributed to the disease in 2005 alone. These
sobering and well-recognized risks are a major source of distress among women free from the
disease, and among those who have completed treatment for new onset disease. Regarding the
latter, clinical interventions are virtually absent during the highly stressful transitional
period in coming off treatment to becoming a breast cancer survivor, and no studies have
tested interventions to reduce distress, particularly fear of recurrence, and improve
quality of life during this time. Therefore, we proposed to conduct a two-armed randomized
wait-list controlled study on use of a mindfulness-based stress reduction (MBSR)
intervention among 100 female breast cancer patients (stages 0-III) who have recently
completed treatment with surgery, radiation and/or chemotherapy. Specifically, we
investigated: (i) whether MBSR favorably influences psychological status, quality of life,
stress hormones, and immune status; and (ii) possible mechanisms by which MBSR may work, in
particular, through a reduction in fear of breast cancer recurrence. Both objectives were
studied at the critical transition time following completion of surgical and adjuvant
therapies (end of treatment to 18 months thereafter) for breast cancer. The MBSR
intervention included 6 weeks of class sessions according to the curriculum established by
Kabat Zinn and Santorelli. Analysis of covariance models are being used to assess whether
change in the above-defined outcomes varies by random assignment (MBSR or wait-list), per
the intention-to-treat principle. Moreover, change (reduction) in fear of recurrence
attributed to MBSR is being investigated as a mediator. If this R21 exploratory study shows
that MBSR improves patient proximal outcomes following completion of breast cancer
treatment, the science will be mature enough for future large-scale evaluation of MBSR as a
potential therapy to reduce long-term morbidity and mortality in breast cancer patient

Inclusion Criteria:

- 21 years old or older

- Diagnosed with Stage 0, I, II, or III breast cancer

- Undergone lumpectomy and completed adjuvant radiation and/or chemotherapy (end of
treatment to 18 months post-treatment)

- Ability to read and speak English at the 8th grade level to respond to the survey

Exclusion Criteria:

- Advanced stage (IV) breast cancer

- History of mastectomy

- Current psychiatric diagnosis

- Recurrent treatment for prior breast cancer

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

To assess whether MBSR favorably influences psychological status (anxiety, perceived stress, depression), quality of life, and immune status (among post-treatment breast cancer survivors)

Outcome Time Frame:

6 weeks

Safety Issue:


Principal Investigator

Cecile A Lengacher, RN PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of South Florida


United States: Institutional Review Board

Study ID:




Start Date:

March 2006

Completion Date:

June 2012

Related Keywords:

  • Breast Cancer
  • breast cancer
  • survivors
  • Breast Neoplasms



University of South Florida Tampa, Florida  33612