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 propose 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 0-3) who have recently completed treatment with surgery, radiation and/or chemotherapy. Specifically, we will investigate: (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 will be studied at the critical transition time following completion of surgical and adjuvant therapies (6 weeks to 6 months thereafter) for breast cancer. The MBSR intervention will include 8 weeks of class sessions according to the curriculum established by Kabat Zinn and Santorelli. Analysis of covariance models will be 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 will be 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 populations. ? ?

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Exploratory/Developmental Grants (R21)
Project #
1R21CA109168-01A2
Application #
7028534
Study Section
Behavioral Medicine, Interventions and Outcomes Study Section (BMIO)
Program Officer
Jeffery, Diana D
Project Start
2006-03-01
Project End
2008-02-29
Budget Start
2006-03-01
Budget End
2007-02-28
Support Year
1
Fiscal Year
2006
Total Cost
$165,300
Indirect Cost
Name
University of South Florida
Department
Type
Schools of Nursing
DUNS #
069687242
City
Tampa
State
FL
Country
United States
Zip Code
33612
Lengacher, Cecile A; Shelton, Melissa M; Reich, Richard R et al. (2014) Mindfulness based stress reduction (MBSR(BC)) in breast cancer: evaluating fear of recurrence (FOR) as a mediator of psychological and physical symptoms in a randomized control trial (RCT). J Behav Med 37:185-95
Reich, Richard R; Lengacher, Cecile A; Kip, Kevin E et al. (2014) Baseline immune biomarkers as predictors of MBSR(BC) treatment success in off-treatment breast cancer patients. Biol Res Nurs 16:429-37
Lengacher, Cecile A; Kip, Kevin E; Post-White, Janice et al. (2013) Lymphocyte recovery after breast cancer treatment and mindfulness-based stress reduction (MBSR) therapy. Biol Res Nurs 15:37-47
Lengacher, Cecile A; Reich, Richard R; Post-White, Janice et al. (2012) Mindfulness based stress reduction in post-treatment breast cancer patients: an examination of symptoms and symptom clusters. J Behav Med 35:86-94
Lengacher, Cecile A; Johnson-Mallard, Versie; Post-White, Janice et al. (2009) Randomized controlled trial of mindfulness-based stress reduction (MBSR) for survivors of breast cancer. Psychooncology 18:1261-72
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