Clinical trial NCT02786797: Efficacy of MBSR Treatment of Cognitive Impairment Among Breast Cancer Survivors
Official title: Efficacy of MBSR Treatment of Cognitive Impairment Among Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer
mindfulness-based stress reduction
cognitive impairment
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2016-06-01
Enrollment: 214
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate MBSR(BC), an intensive meditation-based stress reduction intervention, in order to determine its efficacy in improving cognitive functioning among breast cancer survivors. The study will employ a three group randomized design that will (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, in addition it will be delivered to a sub-group in Spanish. If shown to be efficacious, the possibility exists of utilizing this intervention in other types of cancers as well as non-cancer health-related disorders in order to minimize the morbidity experienced by these populations.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Women age 21 or older who have:

  1. a diagnosis of stage I, II, or III breast cancer;
  2. completed CT or CT and radiation and are within 5 years post-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

Primary outcomes:
measure: Change in Executive Functioning from baseline to 6 months.
timeFrame: Baseline, 6 weeks (post intervention), 12 weeks follow-up and 6 months follow-up.
Secondary outcomes:
measure: Change in Executive Function from baseline to 6 months.
timeFrame: Baseline, 6 weeks (post intervention), 12 weeks follow-up and 6 months follow-up.
measure: Change in Visuospatial Memory from baseline to 6 months.
timeFrame: Baseline, 6 weeks (post intervention), 12 weeks follow-up and 6 months follow-up.
measure: Change in Verbal Memory from baseline to 6 months.
timeFrame: Baseline, 6 weeks (post intervention), 12 weeks follow-up and 6 months follow-up.
measure: Change in Logical Memory from baseline to 6 months.
timeFrame: Baseline, 6 weeks (post intervention), 12 weeks follow-up and 6 months follow-up.
measure: Change in Attention and Concentration from baseline to 6 months.
timeFrame: Baseline, 6 weeks (post intervention), 12 weeks follow-up and 6 months follow-up.
measure: Change in Verbal fluency from baseline to 6 months.
timeFrame: Baseline, 6 weeks (post intervention), 12 weeks follow-up and 6 months follow-up.
measure: Change in Cognitive Functioning from baseline to 6 months.
timeFrame: Baseline, 6 weeks (post intervention), 12 weeks follow-up and 6 months follow-up.
Other outcomes:
Locations:
city: Sarasota
country: United States
facility: Sarasota Memorial Hospital
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Tampa
country: United States
facility: USF Health Carol and Frank Morsani Center
state: Florida
city: Tampa
country: United States
facility: Florida Hospital Tampa
state: Florida
Study officials:
References: