This randomized trial studies how well a mindfulness-based stress reduction program helps participants with breast cancer that has spread to other places in the body. A cancer diagnosis is a life-changing and highly stressful event for most people, often resulting in marked declines in quality of life both during and after treatment. There are approximately 3 million women living with a history of invasive breast cancer in the U.S., with at least 150,000 living with metastatic disease. Patient preferences suggest a high need for complementary and alternative medicine interventions to address these chronic symptoms. Mindfulness-based stress reduction programs may help women living with metastatic breast cancer manage symptoms related to cancer treatment and improve quality of life.
PRIMARY OBJECTIVES: I. To develop a novel online mindfulness-based stress reduction (MBSR) treatment for distressed metastatic breast cancer patients in the hope of reaching patients otherwise unable to participate in traditional interventions due to high symptom burden. II. Determine the impact of the intervention on both patient self-report and biological symptom measures. OUTLINE: Participants are randomized to 1 of 2 arms. INTERVENTION ARM: Participants receive online group sessions over 60 minutes for 6 weeks, including 15 minutes of practice on that session's topic and daily meditation or yoga for 45 minutes. At the conclusion of the study period participants participate in mindfulness meditation over 3 hours. Participants also receive a content manual and relaxation compact disc (CD). CONTROL ARM: Participants randomized to the wait-list control condition complete the online intervention as in the intervention arm after the initial 6-week period has ended.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
44
Correlative studies
Participate in 6-week online program
Ancillary studies
Ancillary studies
Roswell Park Cancer Institute
Buffalo, New York, United States
Feasibility of the online intervention for metastatic breast cancer patients
Successfully completing 4 out of 6 week sessions of online intervention for distressed metastatic breast cancer patients.
Time frame: At 6 weeks
Improvement in depression as measured by the Brief Symptom Inventory (BSI-18)
BSI-18 - a self reported screening inventory to detect states of depression, anxiety and emotional distress.
Time frame: Baseline and 6 weeks
Improvement in anxiety as measured by BSI-18
Self reported screening inventory designed to assess participants level of anxiety.
Time frame: Baseline and 6 weeks
Improvement in fatigue measured with the Functional Assessment of Cancer Therapy Fatigue questionnaire
Measured using the Functional Assessment of Cancer Therapy Fatigue (FACT-Fatigue). A questionnaire assessing fatigue.
Time frame: Baseline and 6 weeks
Improvement in sleep impairment as measured by General Sleep Disturbance Scale
Measured using the General Sleep Disturbance Scale - A 21 item scale rating specific sleep problems from 0 (not at all) to 7 (every day) used to evaluate sleep disturbance
Time frame: Baseline and 6 weeks
Improvement in pain
Visual analog scales will be used to assess multiple pain dimensions per the National Comprehensive Cancer Network (NCCN) guidelines for adult cancer pain.
Time frame: Baseline and 6 weeks
Improvement in quality of life (QOL): FACT-B
This will be measured with the Functional Assessment of Cancer Comparisons made between the baseline and post-intervention assessment (6-week) will utilize one-sided permutation paired t-tests; with bootstrap or non-parametric methods considered as appropriate.
Time frame: Baseline 6 weeks
Improvement in blood pressure
Blood pressure will be taken twice at each of the study time-points to ensure an accurate reading. All outcome measures are treated as quantitative variables and will be summarized by cohort and time-point using the appropriate descriptive statistics. Comparisons made between the baseline and post-intervention assessment (6-week) will utilize one-sided permutation paired t-tests; with bootstrap or non-parametric methods considered as appropriate.
Time frame: Baseline and 6 weeks
Improvement in cancer-related biomarkers
A panel of 25 cytokines reflecting Th1, Th2, and Th17 immunity will be collected, including (GMCSF, IFN-v, IL-1f3, IL-2, IL-4, IL-5, IL-6, IL-9, IL-10, IL-12, IL-13, IL-15, IL-17A, IL-17F, IL-17E/IL-25, IL-21, IL-22, IL-23, IL-27, IL-28A, IL-31, IL-33, MIP-3a/CCL20, TNFa, TNF\|3). To visualize the pattern of immunologic markers that jointly distinguish intervention arms, hypothesis
Time frame: Baseline and 6 weeks
Increases in mindfulness
This will be measured with the Five Facet Mindfulness Questionnaire - (FFMQ). A questionnaire to explore mindfulness.
Time frame: Baseline and 6 weeks
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