Back to resultsEHealth Mindful Movement and Breathing in Improving Outcomes in Participants Undergoing Gynecologic Surgery
Primary Purpose
Female Reproductive System Neoplasm, Malignant Female Reproductive System Neoplasm, Malignant Uterine Neoplasm
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Questionnaire Administration
Supportive Care
Sponsored by
About this trial
This is an interventional supportive care trial for Female Reproductive System Neoplasm
Eligibility Criteria
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
Sites / Locations
- Wake Forest University Health Sciences
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Supportive Care (eMMB)
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Number of Participants Recruited and Completed All Assessments
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.
Number of Participants That Adhered to Study Interventions
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:
Number of Participants Reporting Adverse Events
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.
Percentage of Participants Completing 4-week Visits
To be assessed by calculating the percent of participants who complete the 4-week visit.
Full Information
NCT ID
NCT03379376
First Posted
November 29, 2017
Last Updated
December 20, 2019
Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT03379376
Brief Title
EHealth Mindful Movement and Breathing in Improving Outcomes in Participants Undergoing Gynecologic Surgery
Official Title
EHealth Mindful Movement and Breathing to Improve Gynecologic Cancer Surgery Outcomes: Aim II
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
April 5, 2018 (Actual)
Primary Completion Date
October 15, 2018 (Actual)
Study Completion Date
November 2, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Female Reproductive System Neoplasm, Malignant Female Reproductive System Neoplasm, Malignant Uterine Neoplasm, Ovarian Carcinoma, Ovarian Neoplasm, Suspicious for Malignancy, Uterine Neoplasm
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Supportive Care (eMMB)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Receive questionnaire
Intervention Type
Procedure
Intervention Name(s)
Supportive Care
Other Intervention Name(s)
Supportive Therapy, Symptom Management, Therapy, Supportive
Intervention Description
Undergo eHealth mindful moving and breathing
Primary Outcome Measure Information:
Title
Number of Participants Confident in the Use of EHealth Format
Description
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.
Time Frame
Up to 4 weeks
Secondary Outcome Measure Information:
Title
Number of Participants Recruited and Completed All Assessments
Description
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.
Time Frame
Up to 4 weeks
Title
Number of Participants That Adhered to Study Interventions
Description
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:
Time Frame
Up to 4 weeks
Title
Number of Participants Reporting Adverse Events
Description
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.
Time Frame
Up to 4 weeks
Title
Percentage of Participants Completing 4-week Visits
Description
To be assessed by calculating the percent of participants who complete the 4-week visit.
Time Frame
Up to 4 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie Sohl
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
12. IPD Sharing Statement
Learn more about this trial
EHealth Mindful Movement and Breathing in Improving Outcomes in Participants Undergoing Gynecologic Surgery
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