Clinical trial NCT03379376: 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
Overall status: COMPLETED
Phase: NA
Conditions: Female Reproductive System Neoplasm
Malignant Female Reproductive System Neoplasm
Malignant Uterine Neoplasm
Ovarian Carcinoma
Ovarian Neoplasm
Suspicious for Malignancy
Uterine Neoplasm
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-12-20
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: 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.

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

Primary outcomes:
measure: Number of Participants Confident in the Use of EHealth Format
timeFrame: Up to 4 weeks
Secondary outcomes:
measure: Number of Participants Recruited and Completed All Assessments
timeFrame: Up to 4 weeks
measure: Number of Participants That Adhered to Study Interventions
timeFrame: Up to 4 weeks
measure: Number of Participants Reporting Adverse Events
timeFrame: Up to 4 weeks
measure: Percentage of Participants Completing 4-week Visits
timeFrame: Up to 4 weeks
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Stephanie Sohl
role: PRINCIPAL_INVESTIGATOR
References: