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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
21
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.
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.
Washington University School of Medicine
St Louis, Missouri, United States
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).
Time frame: From Baseline to week 3
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).
Time frame: From Baseline to week 3
Change in symptoms of depression 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).
Time frame: 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.
Time frame: 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).
Time frame: From Baseline to week 3
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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).
Time frame: 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)
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: From Baseline to week 3