A Self-Directed Mindfulness Meditation Intervention in Gynecologic Cancer Patients

NCT04072406 | Terminated

• 1 other identifier: 201905188
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Stage III Gynecologic Cancer; Stage IV Gynecologic Cancer

Keywords

mindfulness; meditation; behavioral treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Change in symptoms of distress as measured by the National Comprehensive Cancer Network Distress Thermometer

  From Baseline to week 3

• Change in symptoms of depression as measured by the Hospital Anxiety and Depression Scale (HADS)

  From Baseline to week 3

• Change in symptoms of fatigue as measured by the Brief Fatigue Inventory (BFI)

  From Baseline to week 3

• Change in overall physical symptoms as measured by the Edmonton Symptoms Associated Scale Revised

  From Baseline to week 3

• Change in emotion regulation as measured by the Emotion Regulation Questionnaire

  From Baseline to week 3

Study Arms (2)

Arm I: Usual Care

ACTIVE COMPARATOR

* 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

Other: Usual care packet

Arm II: Mindfulness Meditation

EXPERIMENTAL

* 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

Other: Mindfulness meditation

Interventions

Mindfulness meditation OTHER

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

Usual care packet OTHER

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 I: Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• \<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).

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Washington University Department of Psychological and Brain Sciences: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

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

MeSH Terms

Interventions

Mindfulness

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Brian Carpenter, Ph.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2019
• First Posted: August 28, 2019
• Study Start: July 23, 2019
• Primary Completion: April 10, 2020
• Study Completion: April 10, 2020
• Last Updated: December 30, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)