A Self-Directed Mindfulness Meditation Intervention in Gynecologic Cancer Patients

Stage III Gynecologic Cancer Clinical Trial

Official title:

A Self-Directed Mindfulness Meditation Intervention in Gynecologic Cancer Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04072406
• Other study ID #: 201905188
• Status: Terminated
• Phase: N/A
• Start date: July 23, 2019
• Est. completion date: April 10, 2020

Study information

• Verified date: April 2020
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: April 10, 2020
• Est. primary completion date: April 10, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Stage III Gynecologic Cancer
• Stage IV Gynecologic Cancer

Intervention

Other:
• Mindfulness 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.
• Usual 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.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Washington University Department of Psychological and Brain Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine