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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Female Reproductive System Neoplasm, Malignant Female Reproductive System Neoplasm, Malignant Uterine Neoplasm, Ovarian Carcinoma, Ovarian Neoplasm, Suspicious for Malignancy, Uterine Neoplasm

Intervention / Treatment
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* Other: Questionnaire Administration
* Procedure: Supportive Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive Care (eMMB)<br>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<br>* Receive questionnaire<br>Procedure: Supportive Care<br>* Undergo eHealth mindful moving and breathing<br>* Other names: Therapy, Supportive;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 4 weeks | 
| 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: | Up to 4 weeks | 
| 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. | Up to 4 weeks | 
| Percentage of Participants Completing 4-week Visits | To be assessed by calculating the percent of participants who complete the 4-week visit. | Up to 4 weeks |