Mindfulness-based Stress Reduction in Breast Cancer Recovery
June 14, 2012 updated by: University of South Florida
Effects of MBSR in Early Stage Breast Cancer Recovery
The purpose of this study was two-fold: (i) to assess whether MBSR favorably influences psychological status, quality of life, stress hormones, and immune status in breast cancer survivors; and (ii) to explore possible mechanisms by which MBSR may favorably influence these outcomes, in particular, through reduction in fear of breast cancer recurrence and associated perceived stress.
Both objectives were studied at the critical transition time immediately following completion of surgical, radiation and/or chemotherapy therapy for breast cancer.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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 populations.
Study Type
Interventional
Enrollment (Actual)
84
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
-
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Florida
-
Tampa, Florida, United States, 33612
- University of South Florida
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-
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 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 questions
Exclusion Criteria:
- Advanced stage (IV) breast cancer
- History of mastectomy
- 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: 1
|
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.
Other Names:
|
|
No Intervention: 2
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To assess whether MBSR favorably influences psychological status (anxiety, perceived stress, depression), quality of life, and immune status (among post-treatment breast cancer survivors)
Time Frame: 6 weeks
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To explore possible mechanisms by which MBSR may favorably influence psychological status, quality of life, and/or immune status (in other words, "how" MBSR may work) (among post-treatment breast cancer survivors)
Time Frame: 6 weeks
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
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
March 1, 2006
Primary Completion (Actual)
February 1, 2012
Study Completion (Actual)
June 1, 2012
Study Registration Dates
First Submitted
December 21, 2007
First Submitted That Met QC Criteria
December 31, 2007
First Posted (Estimate)
January 2, 2008
Study Record Updates
Last Update Posted (Estimate)
June 18, 2012
Last Update Submitted That Met QC Criteria
June 14, 2012
Last Verified
December 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R21CA109168 (U.S. NIH Grant/Contract)
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