Clinical trial NCT00584142: Mindfulness-based Stress Reduction in Breast Cancer Recovery
Official title: Effects of MBSR in Early Stage Breast Cancer Recovery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer
survivors
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2008-01-02
Enrollment: 84
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: To assess whether MBSR favorably influences psychological status (anxiety, perceived stress, depression), quality of life, and immune status (among post-treatment breast cancer survivors)
timeFrame: 6 weeks
Secondary outcomes:
measure: 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)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida
state: Florida
Study officials:
affiliation: University of South Florida
name: Cecile A Lengacher, RN PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lengacher CA, Johnson-Mallard V, Post-White J, Moscoso MS, Jacobsen PB, Klein TW, Widen RH, Fitzgerald SG, Shelton MM, Barta M, Goodman M, Cox CE, Kip KE. Randomized controlled trial of mindfulness-based stress reduction (MBSR) for survivors of breast cancer. Psychooncology. 2009 Dec;18(12):1261-72. doi: 10.1002/pon.1529.