Self-Directed Mindfulness Meditation for the Reduction of Anxiety and Distress in Patients with Progressive or Recurrent Stage III or IV Gynecologic Cancers

Status: Active

Description

This trial studies how well a self-directed mindfulness meditation intervention works in reducing anxiety and distress in patients with stage III-IV gynecologic cancers that are growing, spreading, or getting worse (progressive) or have come back (recurrent). Mindfulness meditation is based on the concept of being "mindful", or having increased awareness, of the present. It uses breathing methods, guided imagery, and other practices to relax the body and mind and help reduce stress. The purpose of this study is to test the effects a meditation program that patients listen to at home on physical and psychological symptoms.

Eligibility Criteria

Inclusion Criteria

  • Have a diagnosis of stage III or IV, progressive or recurrent gynecologic cancer (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
  • 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) will not be eligible
  • Individuals who are not currently practicing weekly meditation will also not be eligible
  • Due to overlap in surveys for other ongoing trials in the Division of Gynecologic Oncology, patients may not be currently enrolled on protocol Institutional Review Board (IRB)#: 201511102 (chemoresistance) or IRB# 201804169 (cytokine-induced depression)

Locations & Contacts

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: Active
Contact: Brian Carpenter
Phone: 314-935-8212
Email: bcarpenter@wustl.edu

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To investigate effects of the mindfulness meditation intervention compared to usual care on anxiety and other psychological outcomes.

II. To investigate effects of the mindfulness meditation intervention compared to usual care on physical distress outcomes.

III. To assess patient acceptability of the mindfulness meditation intervention.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients listen to a mindfulness meditation recording over 20-25 minutes daily for 3 weeks.

ARM II: Patients receive usual care.

After completion of study, patients are followed up at 1 month.

Trial Phase & Type

Trial Phase

No phase specified

Trial Type

Supportive care

Lead Organization

Lead Organization
Siteman Cancer Center at Washington University

Principal Investigator
Brian Carpenter

Trial IDs

Primary ID 201905188
Secondary IDs NCI-2019-05876
Clinicaltrials.gov ID NCT04072406