NCT03379376

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2017

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 20, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

April 5, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2018

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2018

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

December 23, 2019

Completed
Last Updated

December 30, 2019

Status Verified

December 1, 2019

Enrollment Period

6 months

First QC Date

November 29, 2017

Results QC Date

October 25, 2019

Last Update Submit

December 20, 2019

Conditions

Female Reproductive System NeoplasmMalignant Female Reproductive System NeoplasmMalignant Uterine NeoplasmOvarian CarcinomaOvarian NeoplasmSuspicious for MalignancyUterine Neoplasm

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Confident in the Use of EHealth Format

    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 Outcomes (4)

  • Number of Participants Recruited and Completed All Assessments

    Up to 4 weeks

  • Number of Participants That Adhered to Study Interventions

    Up to 4 weeks

  • Number of Participants Reporting Adverse Events

    Up to 4 weeks

  • Percentage of Participants Completing 4-week Visits

    Up to 4 weeks

Study Arms (1)

Supportive Care (eMMB)

EXPERIMENTAL

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 AdministrationProcedure: Supportive Care

Interventions

Questionnaire AdministrationOTHER

Receive questionnaire

Supportive Care (eMMB)
Supportive CarePROCEDURE

Undergo eHealth mindful moving and breathing

Also known as: Supportive Therapy, Symptom Management, Therapy, Supportive
Supportive Care (eMMB)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Genital Neoplasms, FemaleUterine NeoplasmsOvarian Neoplasms

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Urogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesUterine DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Results Point of Contact

Title
Meg O'Mara - Study Coordinator
Organization
Wake Forest University Health Sciences
megreen@wakehealth.edu
336-716-5440

Study Officials

  • Stephanie Sohl

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2017

First Posted

December 20, 2017

Study Start

April 5, 2018

Primary Completion

October 15, 2018

Study Completion

November 2, 2018

Last Updated

December 30, 2019

Results First Posted

December 23, 2019

Record last verified: 2019-12

Locations

US(1)