A Self-Directed Mindfulness Meditation Intervention in Gynecologic Cancer Patients

Study Overview
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Brief Summary
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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.

Official Title
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A Self-Directed Mindfulness Meditation Intervention in Gynecologic Cancer Patients

Conditions
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Stage III Gynecologic Cancer, Stage IV Gynecologic Cancer

Intervention / Treatment
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* Other: Mindfulness meditation
* Other: Usual care packet


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm I: Usual Care<br>Participants assigned to usual care will receive a packet of instructions with information about how to complete weekly surveys via a link that will be emailed to them Participants in both arms will be asked to complete a total of five surveys: baseline, at the end of each of three weeks, and a final survey one month later | Other: Usual care packet<br>* 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.<br>|
| Experimental: Arm II: Mindfulness Meditation<br>Participants will listen to mindfulness meditations daily over the course of three weeks. Participants in both arms will be asked to complete a total of five surveys: baseline, at the end of each of three weeks, and a final survey one month later | Other: Mindfulness meditation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | -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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mindfulness, meditation, behavioral treatment