Stage IV Breast Cancer Clinical Trial
Official title:
RCT of Online Mindfulness-Based Stress Reduction for Metastatic Breast Cancer Patients
Verified date | July 2022 |
Source | Roswell Park Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 44 |
Est. completion date | April 6, 2020 |
Est. primary completion date | June 19, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - A diagnosis of metastatic breast cancer within the past 5 years and treated at Roswell Park Cancer Institute (RPCI) - Ability to read and understand English - Current distress score of 4+ on the National Comprehensive Cancer Network (NCCN) distress thermometer - Access to an Internet connection with own device (computer, tablet, smartphone, etc.) - Patient not currently involved in an ongoing psychological intervention - If taking prescribed medication for mood or anxiety disorder, dosage has been consistent for prior 3 months Exclusion Criteria: - Unable to speak and understand English - Prior or current experience with mindfulness-based practice - Diagnosis of a psychotic disorder, bipolar disorder, substance abuse disorder, or reported suicidality - Current involvement in any other psychological treatment (excluding medication) during study duration - Currently being treated for another cancer diagnosis other than metastatic breast cancer |
Country | Name | City | State |
---|---|---|---|
United States | Roswell Park Cancer Institute | Buffalo | New York |
Lead Sponsor | Collaborator |
---|---|
Roswell Park Cancer Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | At 6 weeks | |
Secondary | 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. | Baseline and 6 weeks | |
Secondary | Improvement in anxiety as measured by BSI-18 | Self reported screening inventory designed to assess participants level of anxiety. | Baseline and 6 weeks | |
Secondary | 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. | Baseline and 6 weeks | |
Secondary | 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 | Baseline and 6 weeks | |
Secondary | 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. | Baseline and 6 weeks | |
Secondary | 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. | Baseline 6 weeks | |
Secondary | 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. | Baseline and 6 weeks | |
Secondary | 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 | Baseline and 6 weeks | |
Secondary | Increases in mindfulness | This will be measured with the Five Facet Mindfulness Questionnaire - (FFMQ). A questionnaire to explore mindfulness. | Baseline and 6 weeks |
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