EHealth Mindful Movement and Breathing in Improving Outcomes in Participants Undergoing Gynecologic Surgery
Study Details
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Detailed Description
PRIMARY OBJECTIVES:
- 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 Design
Arms and Interventions
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:
|
Outcome Measures
Primary Outcome Measures
- Number of Participants Confident in the Use of EHealth Format [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.
Secondary Outcome Measures
- Number of Participants Recruited and Completed All Assessments [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.
- Number of Participants That Adhered to Study Interventions [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:
- Number of Participants Reporting Adverse Events [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.
- Percentage of Participants Completing 4-week Visits [Up to 4 weeks]
To be assessed by calculating the percent of participants who complete the 4-week visit.
Eligibility Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Wake Forest University Health Sciences | Winston-Salem | North Carolina | United States | 27157 |
Sponsors and Collaborators
- Wake Forest University Health Sciences
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Stephanie Sohl, Wake Forest University Health Sciences
Study Documents (Full-Text)
More Information
Publications
None provided.- IRB00046462
- NCI-2018-00584
- CCCWFU 04517
- P30CA012197
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Supportive Care (eMMB) |
---|---|
Arm/Group 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. Questionnaire Administration: Receive questionnaire Supportive Care: Undergo eHealth mindful moving and breathing |
Period Title: Overall Study | |
STARTED | 10 |
COMPLETED | 5 |
NOT COMPLETED | 5 |
Baseline Characteristics
Arm/Group Title | Supportive Care (eMMB) |
---|---|
Arm/Group 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. Questionnaire Administration: Receive questionnaire Supportive Care: Undergo eHealth mindful moving and breathing |
Overall Participants | 10 |
Age (Years) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [Years] |
58.2
(14.4)
|
Sex: Female, Male (Count of Participants) | |
Female |
10
100%
|
Male |
0
0%
|
Ethnicity (NIH/OMB) (Count of Participants) | |
Hispanic or Latino |
0
0%
|
Not Hispanic or Latino |
10
100%
|
Unknown or Not Reported |
0
0%
|
Race (NIH/OMB) (Count of Participants) | |
American Indian or Alaska Native |
0
0%
|
Asian |
0
0%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
Black or African American |
1
10%
|
White |
8
80%
|
More than one race |
1
10%
|
Unknown or Not Reported |
0
0%
|
Region of Enrollment (Count of Participants) | |
United States |
10
100%
|
Outcome Measures
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 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Supportive Care (eMMB) |
---|---|
Arm/Group 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. Questionnaire Administration: Receive questionnaire Supportive Care: Undergo eHealth mindful moving and breathing |
Measure Participants | 10 |
Count of Participants [Participants] |
7
70%
|
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 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Supportive Care (eMMB) |
---|---|
Arm/Group 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. Questionnaire Administration: Receive questionnaire Supportive Care: Undergo eHealth mindful moving and breathing |
Measure Participants | 10 |
Count of Participants [Participants] |
5
50%
|
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 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Supportive Care (eMMB) |
---|---|
Arm/Group 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. Questionnaire Administration: Receive questionnaire Supportive Care: Undergo eHealth mindful moving and breathing |
Measure Participants | 10 |
Count of Participants [Participants] |
7
70%
|
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 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Supportive Care (eMMB) |
---|---|
Arm/Group 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. Questionnaire Administration: Receive questionnaire Supportive Care: Undergo eHealth mindful moving and breathing |
Measure Participants | 10 |
Count of Participants [Participants] |
1
10%
|
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 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Supportive Care (eMMB) |
---|---|
Arm/Group 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. Questionnaire Administration: Receive questionnaire Supportive Care: Undergo eHealth mindful moving and breathing |
Measure Participants | 10 |
Count of Participants [Participants] |
5
50%
|
Adverse Events
Time Frame | Nonserious adverse events will be monitored on a quarterly basis and serious adverse events up to 4 weeks. | |
---|---|---|
Adverse Event Reporting Description | ||
Arm/Group Title | Supportive Care (eMMB) | |
Arm/Group 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. Questionnaire Administration: Receive questionnaire Supportive Care: Undergo eHealth mindful moving and breathing | |
All Cause Mortality |
||
Supportive Care (eMMB) | ||
Affected / at Risk (%) | # Events | |
Total | 1/10 (10%) | |
Serious Adverse Events |
||
Supportive Care (eMMB) | ||
Affected / at Risk (%) | # Events | |
Total | 1/10 (10%) | |
Infections and infestations | ||
Sepsis | 1/10 (10%) | 1 |
Other (Not Including Serious) Adverse Events |
||
Supportive Care (eMMB) | ||
Affected / at Risk (%) | # Events | |
Total | 0/10 (0%) |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Meg O'Mara - Study Coordinator |
---|---|
Organization | Wake Forest University Health Sciences |
Phone | 336-716-5440 |
megreen@wakehealth.edu |
- IRB00046462
- NCI-2018-00584
- CCCWFU 04517
- P30CA012197