A Self-Directed Mindfulness Meditation Intervention in Gynecologic Cancer Patients
NCT ID: NCT04072406
Last Updated: 2024-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
21 participants
INTERVENTIONAL
2019-07-23
2020-04-10
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm I: Usual Care
* 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
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.
Arm II: Mindfulness Meditation
* 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
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
FEMALE
No
Sponsors
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Washington University Department of Psychological and Brain Sciences
UNKNOWN
Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Brian Carpenter, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Washington University School of Medicine
St Louis, Missouri, United States
Countries
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Related Links
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Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Other Identifiers
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201905188
Identifier Type: -
Identifier Source: org_study_id