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Covid-19
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| Name | Class |
|---|---|
| Washington University Department of Psychological and Brain Sciences | UNKNOWN |
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The current study examines the effects of a 3-week, at-home mindfulness mediation intervention (MMI) to address psychological and physical distress in patients with gynecologic cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I: Usual Care | Active Comparator |
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| Arm II: Mindfulness Meditation | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness meditation | Other | Participants assigned to either condition who do not have a personal electronic device for listening to meditations or completing survey will receive a loaned device from the study team. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in symptoms of anxiety as measured by the Hospital Anxiety and Depression Scale (HADS) | -On the 14-item Hospital Anxiety and Depression Scale (HADS) symptoms of anxiety (7) and depression (7) are rated on a scale from 0 (less severe) to 3 (more severe). | From Baseline to week 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in symptoms of distress as measured by the National Comprehensive Cancer Network Distress Thermometer | -Patients rate distress on a scale from 0 (no distress) to 10 (extreme distress). | From Baseline to week 3 |
| Change in symptoms of depression as measured by the Hospital Anxiety and Depression Scale (HADS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian Carpenter, Ph.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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| ID | Term |
|---|---|
| D064866 | Mindfulness |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Usual care packet | Other | Participants assigned to either condition who do not have a personal electronic device for listening to meditations or completing survey will receive a loaned device from the study team. |
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-On the 14-item Hospital Anxiety and Depression Scale (HADS) symptoms of anxiety (7) and depression (7) are rated on a scale from 0 (less severe) to 3 (more severe). |
| From Baseline to week 3 |
| Change in symptoms of fatigue as measured by the Brief Fatigue Inventory (BFI) | -includes 9 items to measure the severity of fatigue-related symptoms on a scale from 0 (no fatigue) to 10 (fatigue as bad as you can imagine). Items include ratings of fatigue at three time points: fatigue when it is at its "worst," fatigue when it is at its "usual" level, and fatigue as it is experienced "now," in the moment. | From Baseline to week 3 |
| Change in overall physical symptoms as measured by the Edmonton Symptoms Associated Scale Revised | -The Edmonton Symptoms Assessment Scale Revised is a 10-item scale that measures severity of 10 physical and psychological symptoms (e.g., nausea, drowsiness, tiredness, anxiety) on a scale from 0 (e.g., no nausea) to 10 (e.g., worst possible nausea). | From Baseline to week 3 |
| Change in emotion regulation as measured by the Emotion Regulation Questionnaire | -measures two emotion regulation strategies, cognitive reappraisal and expressive suppression. Respondents rate 10 items about these strategies on a scale from 1 (strongly disagree) to 7 (strongly agree). | From Baseline to week 3 |
| Change in coping as measured by the Cognitive Emotion Regulation Questionnaire | -Will assess 20 items from four subscales (acceptance, rumination, positive reappraisal, putting into perspective, and self-blame) | From Baseline to week 3 |
| Change in mindfulness as measured by the Five-Facet Mindfulness Questionnaire | -Assesses observing, describing, acting with awareness, non-judging, and non-reactivity. Participants rate 15 items on a scale from 1 (never or very rarely true) to 5 (very often or always true). | From Baseline to week 3 |
| Change in self-compassion as measured by the Sussex-Oxford Compassion for Self Scale | -20-item scale that measures overall compassion for the self. The items are divided into five subscales that correspond to the five components of self-compassion. Items are rated from 1 (not at all true) to 5 (always true). | From Baseline to week 3 |
| Change in perceived stress as measured by the Perceived Stress Scale | -10-item measure of globally perceived stress. The measure invites participants to retrospectively report their feelings and thoughts about various topics during the last month, including "how often [you] have felt upset because of something that happened unexpectedly," "how often [you] have felt that things were going your way," and "how often [you] could not cope with all the things that you had to do." Participants rate each item on a scale of 0 (Never) to 5 (Very Often), and a higher score indicates greater stress. | From Baseline to week 3 |