Clinical trial NCT04072406: A Self-Directed Mindfulness Meditation Intervention in Gynecologic Cancer Patients
Official title: A Self-Directed Mindfulness Meditation Intervention in Gynecologic Cancer Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stage III Gynecologic Cancer
Stage IV Gynecologic Cancer
Keywords: mindfulness
meditation
behavioral treatment
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Washington University Department of Psychological and Brain Sciences
First posted: 2019-08-28
Enrollment: 21
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Change in symptoms of anxiety as measured by the Hospital Anxiety and Depression Scale (HADS)
timeFrame: From Baseline to week 3
Secondary outcomes:
measure: Change in symptoms of distress as measured by the National Comprehensive Cancer Network Distress Thermometer
timeFrame: From Baseline to week 3
measure: Change in symptoms of depression as measured by the Hospital Anxiety and Depression Scale (HADS)
timeFrame: From Baseline to week 3
measure: Change in symptoms of fatigue as measured by the Brief Fatigue Inventory (BFI)
timeFrame: From Baseline to week 3
measure: Change in overall physical symptoms as measured by the Edmonton Symptoms Associated Scale Revised
timeFrame: From Baseline to week 3
measure: Change in emotion regulation as measured by the Emotion Regulation Questionnaire
timeFrame: From Baseline to week 3
measure: Change in coping as measured by the Cognitive Emotion Regulation Questionnaire
timeFrame: From Baseline to week 3
measure: Change in mindfulness as measured by the Five-Facet Mindfulness Questionnaire
timeFrame: From Baseline to week 3
measure: Change in self-compassion as measured by the Sussex-Oxford Compassion for Self Scale
timeFrame: From Baseline to week 3
measure: Change in perceived stress as measured by the Perceived Stress Scale
timeFrame: From Baseline to week 3
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Brian Carpenter, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: