Mindfulness-Based Stress Reduction (MBSR) Symptom Cluster Trial for Breast Cancer Survivors

February 25, 2014 updated by: Cecile Lengacher
The purpose of this study among breast cancer survivors is three-fold: (i) to evaluate the efficacy of the MBSR(BC) program in improving psychological and physical symptoms, quality of life and measures of immune function and a stress hormone (cortisol); (ii) to test whether positive effects achieved from the MBSR(BC) program are mediated through changes in mindfulness and fear of recurrence of breast cancer; and (iii) to evaluate whether positive effects achieved from the MBSR(BC) program are modified by specific patient characteristics measured at baseline.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Breast cancer survivors are living longer and may be living with many symptoms incurred from the disease and its treatment. Survivors from 1 to 2 years off treatment report continued fatigue, depression, pain and sleep disturbances (Kenefick 2006; Byar et al. 2006). Patients often present with several concurrent symptoms (Dodd et al. 2001; Esper and Heidrich 2005). It is believed that symptoms tend to cluster together (two or more concurrent symptoms related to one another and independent of other symptoms) and may have natural associations, similar shared pathways and underlying mechanisms (Barsevick 2007). Currently, little is known about how symptoms cluster in breast cancer survivors after treatment, underlying mechanisms, and if interventions can influence multiple symptoms simultaneously (Lee et al. 2004; Cleeland et al. 2003). Very few studies have tested interventions during post-treatment survivorship (Cimprich et al. 2005; Mishel et al. 2005; Stanton et al. 2005; Scheier et al. 2005). Mindfulness-Based Stress Reduction (MBSR), a standardized form of meditation and yoga, has been shown to be effective in reducing anxiety, depression and stress in patients with chronic pain (Kabat-Zinn et al. 1992; Miller et al. 1995; Teasdale et al. 2000; Kabat-Zinn et al. 1985). Preliminary results from 2 pilot studies conducted by our research team provide support that MBSR for breast cancer survivors may be effective in markedly reducing symptoms, increasing quality of life, and decreasing fears of recurrence (Lengacher et al. 2009; Lengacher et al. 2006). This proposed study builds on our preliminary data of the MBSR Breast Cancer Program (BC) to reduce stress, biological markers of the stress response (pro-inflammatory cytokines) and improve physical, and psychological symptoms and quality of life in breast cancer survivors.

We aim to determine: (i) the extent to which the MBSR(BC) program is efficacious in improving outcomes; (ii) whether positive effects from MBSR(BC) are mediated through increased mindfulness and reduced fear of recurrence; and (iii) if a subgroup of patients can be determined to derive the most benefit from MBSR(BC). Formal specific aims are as follows:

Aim (1). Evaluate the efficacy of the MBSR(BC) program in improving psychological and physical symptoms, quality of life and measures of immune function and a stress hormone (cortisol). We hypothesize that compared to the usual care regimen, patients randomly assigned to the MBSR(BC) program will experience greater improvements at 6 weeks and sustained improvements at 12 weeks in the following:

  1. Individual psychological symptoms, including depression anxiety, and perceived stress;
  2. Individual physical symptoms, including pain, fatigue and sleep dysfunction;
  3. Quality of life;
  4. Biological stress markers (pro-inflammatory immune cytokines, cellular adhesion molecules, lymphocyte subsets) and a stress-related hormone (cortisol).

Aim (2). Test whether positive effects achieved from the MBSR(BC) program (defined in 1a-1d) are mediated through changes in mindfulness and fear of recurrence of breast cancer. We hypothesize that:

  1. Patients in the MBSR(BC) program will report greater increases in mindfulness and larger reductions in fear of recurrence compared to patients assigned to the usual care regimen.
  2. Increased mindfulness will relate directly to improvements in psychological and physical symptoms, quality of life and measures of immune function and a stress hormone (cortisol).
  3. Reductions in fear of recurrence will be associated with improvements in psychological and physical symptoms, quality of life and measures of immune function and a stress hormone (cortisol).
  4. A primary pathway through which MBSR exerts its positive effects (defined in 1a-1d) will be through increased mindfulness leading to reduced fear of recurrence of cancer.

Aim (3). Evaluate whether positive effects achieved from the MBSR(BC) program (defined in 1a-1d) are modified by specific patient characteristics measured at baseline. We hypothesize that efficacy of the MBSR(BC) program will be greatest among patients with:

  1. High anxiety, high perceived stress, low optimism and poor quality of life
  2. Specific symptom profiles (i.e. highly distressed patients), as determined by grouping (clustering) patients according to their presenting symptoms.

To achieve this research goal, we have proposed a 2-group randomized clinical trial among 300 breast cancer survivors who have undergone lumpectomy and/or mastectomy and radiation and/or chemotherapy in the past two years. The MBSR(BC) program will be evaluated against a waitlisted usual care regimen (UC), with patient assessments made at baseline, 6 weeks, and 12 weeks. Patient assessments will provide data on depression, state anxiety, perceived stress, fatigue, pain, sleep, symptom severity, quality of life, mindfulness, fear of recurrence, optimism and social support. Additionally, blood and saliva samples will be collected from participants. Biological stress markers will be measured by blood specimen collection; biological stress markers will include pro-inflammatory and anti-inflammatory cytokines (IL-1β, TNF-α, IL-6, IL-10, IL-1-RA, TNF-RA, IL-8, IFN-gamma), cellular adhesion markers (CD11a, CD54, CD62L, CD45RA, CD45RO) and lymphocyte subsets (CD3, CD19, CD16+56). A stress hormone, cortisol, will be measured by saliva specimen collection. The MBSR(BC) intervention is an adapted 6-week program that follows the curriculum of an 8-week program established by Kabat Zinn and Santorelli. Prior to formal hypothesis testing, the distributions of all explanatory and outcome variables, as well as covariates, will be examined. For outcome variables with skewed distributions, appropriate transformations (e.g. square root, logarithmic, etc.) will be performed to satisfy normality requirements for parametric multivariable linear modeling. This will include choosing the transformation which yields the lowest Anderson-Darling score. In instances in which appropriate transformations cannot be achieved, non-parametric methods will be used.

Results from this study will advance conceptual and clinical knowledge of how a stress-reducing intervention impacts symptoms among breast cancer survivors and in whom it may be most efficacious. Determining stress-related biological effects may be applicable to other stress-reducing intervention studies. This symptom and symptom cluster assessment and intervention model will further our understanding of biology and behavior and test a predictive and personalized model of health care.

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33617
        • University of South Florida
      • Tampa, Florida, United States, 33617
        • Carol and Frank Morsani Center for Advanced Healthcare
      • Tampa, Florida, United States, 33617
        • Moffitt Cancer Center and Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 21 years or older
  • Diagnosed with Stage 0, I, II, or III breast cancer
  • Undergone lumpectomy and/or mastectomy and are at 2 weeks from end of treatment with adjuvant radiation and/or chemotherapy or are a maximum of 2 years out from completion of such treatment
  • Ability to read and speak English at the 8th grade level or above to respond to survey questions

Exclusion Criteria:

  • Advanced stage (IV) cancer
  • Current psychiatric diagnosis
  • Recurrent treatment for prior breast cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MBSR 6 Weeks Program
Behavioral: MBSR 6 Weeks Program
MBSR is a clinical program that provides systematic training to promote stress reduction by self-regulating arousal to stress. The goal of training is to teach participants to become more aware of their thoughts and feelings, and through meditation practice, to have the ability to step back from thoughts and feelings during stressful situations that contribute to increased emotional distress. The intervention incorporates simple yoga, sitting meditation, body scan, and walking meditation in a 6-week program (Kabat-Zinn et al. 1985; Teasdale et al. 1995).
Other Names:
  • MBSR
No Intervention: Usual Care (UC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate the efficacy of the MBSR(BC) program in improving psychological and physical symptoms, quality of life and measures of immune function and a stress hormone (cortisol)
Time Frame: Baseline, 6 weeks and 12 weeks
Baseline, 6 weeks and 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
To test whether positive effects achieved from the MBSR(BC) program are mediated through changes in mindfulness and fear of recurrence of breast cancer
Time Frame: Baseline, 6 weeks and 12 weeks
Baseline, 6 weeks and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cecile Lengacher

Investigators

  • Principal Investigator: Cecile A Lengacher, RN, PhD, University of South Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

August 5, 2010

First Submitted That Met QC Criteria

August 5, 2010

First Posted (Estimate)

August 6, 2010

Study Record Updates

Last Update Posted (Estimate)

February 27, 2014

Last Update Submitted That Met QC Criteria

February 25, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R01CA131080-01A2 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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