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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-00453 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| I 50317 | Other Identifier | Roswell Park Cancer Institute |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control (online sessions, content manual, CD after 6 weeks) | Experimental | 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. |
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| Intervention (online sessions, content manual, relaxation CD) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laboratory Biomarker Analysis | Other | Correlative studies |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Improvement in anxiety as measured by BSI-18 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chi-Chen Hong, PhD | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
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| Meditation-Based Stress Reduction Program | Behavioral | Participate in 6-week online program |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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Self reported screening inventory designed to assess participants level of anxiety. |
| 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. | 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 | 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. | 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. | 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. | 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 | Baseline and 6 weeks |
| Increases in mindfulness | This will be measured with the Five Facet Mindfulness Questionnaire - (FFMQ). A questionnaire to explore mindfulness. | Baseline and 6 weeks |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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