Stage III Gynecologic Cancer, Stage IV Gynecologic Cancer
Conditions
Keywords
mindfulness, meditation, behavioral treatment
Brief summary
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.
Interventions
OTHERMindfulness meditation
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.
OTHERUsual care packet
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.
Sponsors
Washington University Department of Psychological and Brain Sciences
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must be ≥ 18 years old * Have a diagnosis of Stage III or IV, progressive or recurrent GC (endometrial, ovarian, fallopian tube, primary peritoneal, cervical, vulvar, vaginal, or other) * Be native English speakers * Report ≥ 4 on the National Cancer Care Network (NCCN) Distress Thermometer at the time of recruitment; * Not currently be practicing weekly meditation * Be willing to create (or already have) an email address * Have access to internet via a personal electronic device (or be willing to borrow an internet-enabled tablet from the study team).
Exclusion criteria
* \<18 years old * Distress Thermometer ratings ≤ 3 * Non-native English speakers * Individuals with severe depression, and individuals who are having suicidal thoughts. * Individuals who are also not willing to create an email address for the purpose of the study (or individuals who do not have an email address already) * Individuals who are currently practicing weekly meditation * Due to overlap in surveys for other ongoing trials in the Division of Gynecologic Oncology, patients may not be currently enrolled on protocol IRB#: 201511102 (chemoresistance) or IRB# 201804169 (Cytokine-induced depression).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in symptoms of anxiety as measured by the Hospital Anxiety and Depression Scale (HADS) | From Baseline to week 3 | -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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in symptoms of depression as measured by the Hospital Anxiety and Depression Scale (HADS) | From Baseline to week 3 | -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). |
| Change in symptoms of fatigue as measured by the Brief Fatigue Inventory (BFI) | From Baseline to week 3 | -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. |
| Change in overall physical symptoms as measured by the Edmonton Symptoms Associated Scale Revised | From Baseline to week 3 | -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). |
| Change in emotion regulation as measured by the Emotion Regulation Questionnaire | From Baseline to week 3 | -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). |
| Change in symptoms of distress as measured by the National Comprehensive Cancer Network Distress Thermometer | From Baseline to week 3 | -Patients rate distress on a scale from 0 (no distress) to 10 (extreme distress). |
| Change in mindfulness as measured by the Five-Facet Mindfulness Questionnaire | From Baseline to week 3 | -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). |
| Change in self-compassion as measured by the Sussex-Oxford Compassion for Self Scale | From Baseline to week 3 | -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). |
| Change in perceived stress as measured by the Perceived Stress Scale | From Baseline to week 3 | -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. |
| Change in coping as measured by the Cognitive Emotion Regulation Questionnaire | From Baseline to week 3 | -Will assess 20 items from four subscales (acceptance, rumination, positive reappraisal, putting into perspective, and self-blame) |
Countries
United States
Outcome results
None listed