A Self-Directed Mindfulness Meditation Intervention in Gynecologic Cancer Patients

The Washington University

Status: Terminated

Conditions: Stage III Gynecologic Cancer; Stage IV Gynecologic Cancer

Treatments: Other: Mindfulness meditation; Other: Usual care packet

Study type: Interventional

Funder types: Other

Identifiers

NCT04072406

201905188

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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21 participants in 2 patient groups

Arm I: Usual Care

Active Comparator group

Description:

* 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

Treatment:

Other: Usual care packet

Arm II: Mindfulness Meditation

Experimental group

Description:

* 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

Treatment:

Other: Mindfulness meditation