Due to improved detection and treatment, survival rates among breast cancer survivors
have increased. However, breast cancer survivors may experience cognitive impairment (CI)
following treatment, which has been reported by breast cancer survivors up to 10 years
after chemotherapy (CT). There is limited evidence on whether stress-reducing
interventions improve CI in breast cancer survivors. The primary goal of this application
is to establish the Mindfulness-Based Stress Reduction for Breast Cancer (MBSR(BC))
program as an effective treatment for CI in breast cancer survivors. Specifically this
study aim to (1) evaluate the extent to which MBSR(BC) compared to the Breast
Cancer-Education Support (BCES) program or Usual Care (UC) improves cognitive functioning
among breast cancer survivors off treatment; (2) determine if improvements in cognitive
functioning achieved from MBSR(BC) are mediated through increased mindfulness and
decreased rumination and stress; (3) evaluate genetic variants as moderators of MBSR(BC)
on improvements in CI; and (4) determine the impact of MBSR(BC) on healthcare utilization
and costs.
To achieve these aims, the research team will conduct a randomized controlled trial (RCT)
among 300 breast cancer survivors (with an expected completed sample size of 250) with
Stage I-III BC who have received adjuvant CT or CT and radiation. Within this RCT,
MBSR(BC) will be delivered to a sub-population of Spanish speaking breast cancer
survivors. Participants will be randomly assigned in a 1:1:1 ratio to 1 of 3 conditions
(1) the 6-week MBSR(BC) program; (2) the 6-week BCES program; or (3) UC. However, once
the UC condition has reached a total of 30 participants, then randomization at the
baseline assessment will occur in a 1:1 ratio to 1 of 2 conditions: (1) MBSR(BC) and (2)
BCES.
The BCES program will match the MBSR(BC) program for time and attention and parallel the
group support component of MBSR(BC). Assessments will take place at baseline, 6 weeks,12
weeks and 6 months and include clinical history and demographic information, objective
neuropsychological assessments, subjective cognitive and symptom measurements, cost
utilization surveys, and either the blood or buccal (cheek) cells collection for genetic
analyses.
This study is highly innovative to be the first randomized trial to: 1) evaluate the
efficacy of MBSR(BC) among breast cancer survivors for objective neuropsychological and
subjective improvements in cognitive functioning; 2) evaluate genetic profiles as
moderators of MBSR(BC) on improving CI; 3) offer the MBSR trial in Spanish in addition to
English for the purpose of improving cognition; and 4) determine the effect of MBSR(BC)
on CT-induced CI among breast cancer survivors related to health service utilization
costs.
MBSR(BC) provides training to promote stress reduction through self-regulation of
attention and awareness to stressful events. The preliminary results show that MBSR(BC)
improves subjective cognitive functioning. If MBSR(BC) is found to be effective, it will
provide evidence of a viable non-pharmacological method for managing CI in breast cancer
survivors. Additionally, the examination of the effects of the hypothesized mediators may
yield new insights for tailoring MBSR(BC) and/or developing additional interventions to
aid breast cancer survivors. The assessment of genetic polymorphisms to explore if risk
alleles are associated with improvement in cognitive functioning may demonstrate that
specific genetic profiles may modify improvements in CI for those receiving MBSR(BC).
Finally, if MBSR(BC) is shown to be effective, this may significantly impact healthcare
utilization and cost and produce necessary evidence for clinicians, researchers and
policymakers.
