Grant Number:	1R01CA131080-01A2 Interpret this number
Primary Investigator:	Lengacher, Cecile
Organization:	University Of South Florida
Project Title:	Mbsr Symptom Cluster Trial for Breast Cancer Survivors
Fiscal Year:	2009

DESCRIPTION (provided by applicant): Breast cancer is the most prevalent form of cancer among women. After treatment completion, breast cancer survivors frequently experience residual symptoms including pain, fatigue, sleep dysfunction, anxiety, depression, and fear of recurrence. This wide range of post-treatment symptoms, and possibly concomitant stress-related cytokine responses, may occur in combination (clusters). Effective interventions for this understudied group of cancer survivors are paramount given the size of this affected patient population. The primary goal of this application in response to RFA PA-07-074 for the first 2 submissions, and PA- 07-070 for this 3rd submission is to rigorously evaluate the efficacy of the Mindfulness Based Stress Reduction (MBSR) Breast Cancer (BC) program among breast cancer survivors. Specifically, we aim to determine: (1) the extent to which the MBSR (BC) program improves patient outcomes after treatment completion; (2) the manner (mechanisms) by which the MBSR (BC) program is effective; and (3) if particular subgroups of patients derive the most benefit from the MBSR (BC) program. To achieve these aims, we will conduct a randomized clinical trial of 330 women with Stage 0, I, II, and III breast cancer who have undergone lumpectomy and/or mastectomy, and are within 2 years of completion of treatment with adjuvant radiation and/or chemotherapy. This period corresponds to the critical transition time when formal medical treatment has ceased, yet residual symptoms remain. Patients will be randomly assigned in equal probability to the MBSR (BC) program or a waitlisted usual care regimen that is later offered the MBSR (BC) program. Patient assessments will be made at baseline, 6 weeks, and 12 weeks, and will include measures of psychological symptoms (depression, anxiety, perceived stress), physical symptoms (pain, fatigue, sleep dysfunction), quality of life, biological stress markers (pro-inflammatory immune cytokines, cellular adhesion molecules, lymphocyte subsets) and stress-related hormones (cortisol, catecholamines). The MBSR (BC) program to be evaluated is a clinical program that provides systematic training to promote stress reduction by self-regulating arousal to stress. Our group has modified this program for breast cancer survivors and shown preliminary evidence of its efficacy in reducing symptoms. Going forward, we will formally test whether: (1) the MBSR (BC) program results in greater initial (6 week) and short-term sustained (12 week) improvements in psychological symptoms, physical symptoms, quality of life, and biological stress markers compared to Usual Care; (2) patients in the MBSR (BC) program report greater increases in mindfulness and larger reductions in fear of recurrence which, it turn, reduce psychological and physical symptoms and stress-related hormones, as well as improve quality of life; and (3) the efficacy of the MBSR (BC) program is greatest among patients who present with high anxiety, high perceived stress, low optimism, poor quality of life, and specific symptom profiles (i.e. highly distressed patients). PUBLIC HEALTH RELEVANCE: Project Narrative After treatment for breast cancer, survivors often experience debilitating symptoms that occur singly, or more commonly, in clusters. Limited research and treatment regimens have been established to minimize this high degree of morbidity among breast cancer survivors. This study will formally evaluate an intensive meditation- based stress reduction intervention to determine if it is efficacious in improving psychological and physical symptoms, quality of life, and biological stress markers among breast cancer survivors. If this intervention is shown to be efficacious, the possibility exists of extending its use to minimize morbidity for other types of cancers, as well as severe non-cancer health disorders.




Mindfulness-based stress reduction for breast cancer survivors (MBSR(BC)): evaluating mediators of psychological and physical outcomes in a large randomized controlled trial.
Authors: Lengacher C.A. , Gruss L.F. , Kip K.E. , Reich R.R. , Chauca K.G. , Moscoso M.S. , Joshi A. , Tinsley S. , Shani B. , Cousin L. , et al. .
Source: Journal Of Behavioral Medicine, 2021-05-07 00:00:00.0; , .
EPub date: 2021-05-07 00:00:00.0.
PMID: 33963420
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Translational genomic research: the role of genetic polymorphisms in MBSR program among breast cancer survivors (MBSR[BC]).
Authors: Park J.Y. , Lengacher C.A. , Reich R.R. , Alinat C.B. , Ramesar S. , Le A. , Paterson C.L. , Pleasant M.L. , Park H.Y. , Kiluk J. , et al. .
Source: Translational Behavioral Medicine, 2019-07-16 00:00:00.0; 9(4), p. 693-702.
PMID: 30137607
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A Large Randomized Trial: Effects of Mindfulness-Based Stress Reduction (MBSR) for Breast Cancer (BC) Survivors on Salivary Cortisol and IL-6.
Authors: Lengacher C.A. , Reich R.R. , Paterson C.L. , Shelton M. , Shivers S. , Ramesar S. , Pleasant M.L. , Budhrani-Shani P. , Groer M. , Post-White J. , et al. .
Source: Biological Research For Nursing, 2019 01; 21(1), p. 39-49.
EPub date: 2018-08-05 00:00:00.0.
PMID: 30079756
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Feasibility of the mobile mindfulness-based stress reduction for breast cancer (mMBSR(BC)) program for symptom improvement among breast cancer survivors.
Authors: Lengacher C.A. , Reich R.R. , Ramesar S. , Alinat C.B. , Moscoso M. , Cousin L. , Marino V.R. , Elias M.N. , Paterson C.L. , Pleasant M.L. , et al. .
Source: Psycho-oncology, 2018 02; 27(2), p. 524-531.
EPub date: 2017-08-08 00:00:00.0.
PMID: 28665541
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A Randomized Controlled Trial of the Effects of Mindfulness-Based Stress Reduction (MBSR[BC]) on Levels of Inflammatory Biomarkers Among Recovering Breast Cancer Survivors.
Authors: Reich R.R. , Lengacher C.A. , Klein T.W. , Newton C. , Shivers S. , Ramesar S. , Alinat C.B. , Paterson C. , Le A. , Park J.Y. , et al. .
Source: Biological Research For Nursing, 2017 07; 19(4), p. 456-464.
EPub date: 2017-05-01 00:00:00.0.
PMID: 28460534
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Mindfulness-Based Stress Reduction in Post-treatment Breast Cancer Patients: Immediate and Sustained Effects Across Multiple Symptom Clusters.
Authors: Reich R.R. , Lengacher C.A. , Alinat C.B. , Kip K.E. , Paterson C. , Ramesar S. , Han H.S. , Ismail-Khan R. , Johnson-Mallard V. , Moscoso M. , et al. .
Source: Journal Of Pain And Symptom Management, 2017 01; 53(1), p. 85-95.
EPub date: 2016-10-05 00:00:00.0.
PMID: 27720794
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Examination Of Broad Symptom Improvement Resulting From Mindfulness-based Stress Reduction In Breast Cancer Survivors: A Randomized Controlled Trial
Authors: Lengacher C.A. , Reich R.R. , Paterson C.L. , Ramesar S. , Park J.Y. , Alinat C. , Johnson-Mallard V. , Moscoso M. , Budhrani-Shani P. , Miladinovic B. , et al. .
Source: Journal Of Clinical Oncology : Official Journal Of The American Society Of Clinical Oncology, 2016-08-20 00:00:00.0; 34(24), p. 2827-34.
PMID: 27247219
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Moderating Effects Of Genetic Polymorphisms On Improvements In Cognitive Impairment In Breast Cancer Survivors Participating In A 6-week Mindfulness-based Stress Reduction Program
Authors: Lengacher C.A. , Reich R.R. , Kip K.E. , Paterson C.L. , Park H.Y. , Ramesar S. , Jim H.S. , Alinat C.B. , Park J.Y. .
Source: Biological Research For Nursing, 2015 Jul; 17(4), p. 393-404.
PMID: 25882604
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The Effects Of Mindfulness-based Stress Reduction On Objective And Subjective Sleep Parameters In Women With Breast Cancer: A Randomized Controlled Trial
Authors: Lengacher C.A. , Reich R.R. , Paterson C.L. , Jim H.S. , Ramesar S. , Alinat C.B. , Budhrani P.H. , Farias J.R. , Shelton M.M. , Moscoso M.S. , et al. .
Source: Psycho-oncology, 2015 Apr; 24(4), p. 424-32.
PMID: 24943918
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Influence Of Mindfulness-based Stress Reduction (mbsr) On Telomerase Activity In Women With Breast Cancer (bc)
Authors: Lengacher C.A. , Reich R.R. , Kip K.E. , Barta M. , Ramesar S. , Paterson C.L. , Moscoso M.S. , Carranza I. , Budhrani P.H. , Kim S.J. , et al. .
Source: Biological Research For Nursing, 2014 Oct; 16(4), p. 438-47.
PMID: 24486564
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