Efficacy of MBSR Treatment of Cognitive Impairment Among Breast Cancer Survivors

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.

Inclusion Criteria:

- Women age 21 or older who have:

1. a diagnosis of stage I, II, or III breast cancer;

2. Undergone lumpectomy and/or mastectomy, are at 2 weeks from end of treatment with
adjuvant chemotherapy or radiation and/or chemotherapy or are at a maximum of 5
years out from completion of such treatment;

3. BC patients with a previous history of another cancer who have NOT received any
chemotherapy or chemotherapy and radiation, but have only received surgical
treatments are eligible;

4. met the screening criteria for CI through a positive response to at least 1 of 2
scaled questions from the European Organization for Research and Treatment of
Cancer Quality of Life questionnaire (EORTC-QLQ) i.e. Please rate on a scale from
0 to 10, the difficulty level you have in concentrating on things, like reading a
newspaper or watching television? "0" means no difficulty and "10" means very
difficult. Please rate on a scale from 0 to 10, the difficulty level you have in
remembering things. "0" means no difficulty and "10" means very difficult, will
be included.

5. Subjects must have the ability to read and speak English and Spanish at the 8th
grade level or above, and survivors with mild depression, anxiety, or other
psychiatric conditions will be eligible.

Exclusion Criteria:

- Breast cancer survivors with a severe current psychiatric diagnosis (e.g. bipolar
disorder)

- Stage 0 or Stage IV BC

- History of another primary cancer diagnosis, treated with adjuvant chemotherapy

- Previous chemotherapy

- Current diagnosed neurologic disorder

- Or a traumatic brain injury will be excluded