An interventional study of Laboratory Biomarker Analysis and Meditation-Based Stress Reduction Program in Stage IV Breast Cancer, sponsored by Roswell Park Cancer Institute. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-30.
Sponsored by Roswell Park Cancer Institute · Not applicable, Interventional, and Supportive care
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.
12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's enrollment of 44 is below the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Roswell Park Cancer Institute is the lead sponsor of 417 studies on the registry; 64 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 21 (55%) have results posted.
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Exclusion Criteria:
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.
Other: Laboratory Biomarker Analysis · Behavioral: Meditation-Based Stress Reduction Program · Other: Quality-of-Life Assessment · Other: Questionnaire Administration
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 CD.
Other: Laboratory Biomarker Analysis · Behavioral: Meditation-Based Stress Reduction Program · Other: Quality-of-Life Assessment · Other: Questionnaire Administration
Correlative studies
Participate in 6-week online program
Also known as: MBSR, MBSR(BC), Meditation-Based Stress Reduction, Meditation-Based Stress Reduction (Breast Cancer), Meditation-Based Stress Reduction for Breast Cancer
Ancillary studies
Also known as: Quality of Life Assessment
Ancillary studies
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
Ran from Dec 2017 to primary completion in Jun 2019, 18 months.
Of 2,272 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 69. This study's 18 months is below that.
Counting every sponsor, half of 2,345 studies reached it within 34 months; a quarter within 16 and three quarters within 69.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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