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

Not Applicable

Completed

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

Interventions: Other: Questionnaire Administration
Procedure: Supportive Care

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Supportive Care (eMMB)	Questionnaire Administration	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.
Supportive Care (eMMB)	Supportive Care	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
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.
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: