EHealth Mindful Movement and Breathing in Improving Outcomes in Participants Undergoing Gynecologic Surgery

December 20, 2019 updated by: Wake Forest University Health Sciences

EHealth Mindful Movement and Breathing to Improve Gynecologic Cancer Surgery Outcomes: Aim II

This trial determines how well eHealth mindful movement and breathing works to improve outcomes in participants undergoing gynecologic surgery. Supportive therapy, such as eHealth mindful movement and breathing, uses techniques that include gentle movements, breathing, and relaxation techniques which may help participants cope with and improve their surgical experiences.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To field-test implementation strategies of the mindful movement and breathing (eMMB) intervention that has been adapted to the eHealth Format.

OUTLINE:

Participants receive a self-directed 20-minute eMMB video and are instructed to practice eMMB at least once before surgery and daily for 2 weeks after surgery. Participants may also request additional guidance from a yoga instructor via telephone and video conference before surgery and again 1 day after surgery or as soon as feasible.

After completion of study, participants are followed up at 4 weeks from surgery.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Scheduled for an abdominal gynecological surgery (i.e. uterine, ovarian) to remove a mass that is suspected to be malignant
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
  • Cognitively able to complete assessments as judged by the study team
  • Able to understand, read and write English

Exclusion Criteria:

  • Have schizophrenia or any other psychotic disorder
  • Have a diagnosed sleep disorder including untreated obstructive sleep apnea, periodic limb movement disorder, or restless leg syndrome

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Supportive Care (eMMB)
Participants receive a self-directed 20-minute eMMB video and are instructed to practice eMMB at least once before surgery and daily for 2 weeks after surgery. Participants may also request additional guidance from a yoga instructor via telephone and video conference before surgery and again 1 day after surgery or as soon as feasible.
Other: Questionnaire Administration
Receive questionnaire
Procedure: Supportive Care
Undergo eHealth mindful moving and breathing
Other Names:
  • Supportive Therapy
  • Symptom Management
  • Therapy, Supportive

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Confident in the Use of EHealth Format
Time Frame: Up to 4 weeks
This is a feasibility study to iteratively refine the eMMB implementation strategies with 10-15 consecutive participants enrolled. Participants will be asked to complete a brief usability questionnaire about their confidence in their ability to complete the intervention. The number of participants will depend on when a consensus is reached on a manual for implementing interventions and will be determined by calculating 95% confidence intervals around all the secondary outcomes.
Up to 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Recruited and Completed All Assessments
Time Frame: Up to 4 weeks
Participants who were recruited and agreed to participate in the Mindful Movement and Breathing (eMMB) sessions and those who completed all assessments will be computed.
Up to 4 weeks
Number of Participants That Adhered to Study Interventions
Time Frame: Up to 4 weeks
To be determined by comparing participants who were adherent to attending study visits and interventions by an adherence assessment (1) Completion of the videoconference session; (2) any additional contact with the interventionists; (3) use of the self-directed intervention:
Up to 4 weeks
Number of Participants Reporting Adverse Events
Time Frame: Up to 4 weeks
Adverse events will be reported upon occurrence monthly. Specifically, they will be labeled definitely unrelated, definitely related, probably related, or possibly related to the study intervention.
Up to 4 weeks
Percentage of Participants Completing 4-week Visits
Time Frame: Up to 4 weeks
To be assessed by calculating the percent of participants who complete the 4-week visit.
Up to 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 5, 2018

Primary Completion (ACTUAL)

October 15, 2018

Study Completion (ACTUAL)

November 2, 2018

Study Registration Dates

First Submitted

November 29, 2017

First Submitted That Met QC Criteria

December 14, 2017

First Posted (ACTUAL)

December 20, 2017

Study Record Updates

Last Update Posted (ACTUAL)

December 30, 2019

Last Update Submitted That Met QC Criteria

December 20, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00046462
  • P30CA012197 (U.S. NIH Grant/Contract)
  • NCI-2018-00584 (REGISTRY: CTRP (Clinical Trial Reporting Program))
  • CCCWFU 04517 (OTHER: Wake Forest University Health Sciences)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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