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

This study is currently recruiting participants.
Verified January 2013 by University of South Florida
Sponsor:
Information provided by (Responsible Party):
Cecile Lengacher, University of South Florida
ClinicalTrials.gov Identifier:
NCT01177124
First received: August 5, 2010
Last updated: January 17, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Breast Cancer
 Behavioral: MBSR 6 Weeks Program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Mindfulness-Based Stress Reduction (MBSR) Symptom Cluster Trial for Breast Cancer Survivors

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: February 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: MBSR
No Intervention: Usual Care (UC)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01177124

Contacts
Contact: Cecile A Lengacher, PhD 8139749147 clengach@health.usf.edu
Contact: Sophia Ramesar, BS 8133962310 sramesar@health.usf.edu

Locations
United States, Florida
University of South Florida Active, not recruiting
Tampa, Florida, United States, 33617
Moffitt Cancer Center and Research Institute Recruiting
Tampa, Florida, United States, 33617
Principal Investigator: Cecile A Lengacher, RN, PhD            
Carol and Frank Morsani Center for Advanced Healthcare Recruiting
Tampa, Florida, United States, 33617
Principal Investigator: Cecile A Lengacher, RN, PhD            
Sponsors and Collaborators
Cecile Lengacher
Investigators
Principal Investigator: Cecile A Lengacher, RN, PhD University of South Florida
  More Information

Publications:
Lengacher C, Gaurkee D, Mierzejewski A, et al. Feasibility of MBSR in early stage breast cancer recovery, a pilot study. Breast Cancer Research and Treatment. 2006;100(1):s289-290.

Responsible Party: Cecile Lengacher, Principal Investigator, University of South Florida
ClinicalTrials.gov Identifier: NCT01177124     History of Changes
Other Study ID Numbers: 1R01CA131080-01A2
Study First Received: August 5, 2010
Last Updated: January 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of South Florida:
Breast cancer
Survivors
Mindfulness-Based Stress Reduction (MBSR)
Symptoms
Immune markers

Additional relevant MeSH terms:
Breast Neoplasms
Syndrome
Neoplasms by Site
Neoplasms
 Breast Diseases
Skin Diseases
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013