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Clinical Trial 18225

Cancer Type: Breast
Study Type: Supportive Care
NCT#: NCT02786797

Phase: N/A
Prinicipal Investigator:

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Study Title

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




Inclusion Criteria


  • Women age 21 or older who have a diagnosis of stage I, II, or III breast cancer (BC).
  • Have completed chemotherapy (CT) or CT and radiation and are within 2 years post-treatment.
  • Have met the screening criteria for cognitive impairment (CI) through a positive response to at least 1 of 2 questions from the European Organization for Research and Treatment of Cancer Quality of Life questionnaire (EORTC-QLQ) (i.e., [1] "Have you had difficulty in concentrating on things, like reading a newspaper or watching television?", and [2] "Have you had difficulty remembering things?").
  • Have the ability to read and speak English and Spanish at the 8th grade level or above.
  • Survivors with mild depression, anxiety, or other psychiatric conditions.

  • Exclusion Criteria


  • Breast cancer survivors (BCS) with a severe current psychiatric diagnosis (e.g. bipolar disorder).
  • Stage 0 or Stage IV breast cancer (BC).
  • History of another primary cancer diagnosis.
  • Previous chemotherapy (CT).
  • Current neurologic disorder.
  • Traumatic brain injury.

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