Clinical Trials Search
Clinical Trial 18225
Study Type: Supportive Care
Phase of Study: NA
Efficacy of MBSR Treatment on Cognitive Impairment among Breast Cancer Survivors
The purpose of this study is to determine if Mindfulness Based Stress Reduction for Breast Cancer (MBSR(BC)) will help with cognitive impairment "chemo brain", physical symptoms, psychological status, and quality of life among breast cancer survivors. MBSR is a stress reduction program that includes meditation, low impact yoga, and body scan which consists of observing any sensations in the various regions of the body from the head to toes while focusing attention to breathing. MBSR has been used in a large clinical study with breast cancer survivors at Moffitt prior to this study.
Aim 1. Evaluate the extent to which the MBSR(BC) program compared to the BCES program or a UC regimen improves cognitive functioning among BCS, who have received adjuvant CT or CT and radiation. Hypothesis 1: BCS randomly assigned to the MBSR(BC) compared to the BCES program or UC will experience greater improvements at 6 weeks, 12 weeks, and 6 months in objective measures of neuropsychological functioning and self-report perceived cognitive abilities. Aim 2. Determine if improvements in cognitive functioning achieved from the MBSR(BC) program (defined in Aim 1) are mediated through increased mindfulness, decreased rumination, and decreased stress. Hypothesis 2: The effects of MBSR(BC) on improvements in objective neuropsychological functioning (attention/concentration; executive functioning; memory; verbal fluency) and perceived cognitive abilities will be mediated through increased mindfulness, decreased rumination, and decreased stress. Aim 3. Evaluate genetic variants as moderators of MBSR(BC) on improvements in CI. Hypothesis 3: Genetic polymorphisms related to cognitive function will influence the effectiveness of MBSR(BC) on improved CI. Aim 4. Determine the impact of MBSR(BC) on health services utilization and costs. Hypothesis 4: The MBSR(BC) intervention group will show lower health services utilization and costs as compared to the BCES program and UC with regards to improvements in cognitive functioning