Supportive Programs for Supporting Optimal Recovery in Participants Undergoing Gynecological Surgery



Status:Recruiting
Conditions:Ovarian Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/28/2019
Start Date:December 7, 2018
End Date:October 2021

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Support for Optimal Recovery Following Gynecologic Surgery Study (SOARING)

This trial studies how well two different supportive programs work in supporting optimal
recovery in participants undergoing gynecological surgery. Supportive programs use different
methods for helping participants cope with the surgical experience including gentle
movements, counseling, writing, or relaxation techniques, and may help improve participants'
well-being after gynecological surgery.

PRIMARY OBJECTIVES:

I. To calculate recruitment, adherence, assessment completion, and retention rates.

SECONDARY OBJECTIVES:

I. Document the frequency of adverse events. II. Assess descriptive data on proposed outcomes
(i.e., pain, sleep disturbances, psychological distress) for the next phase of study.) III.
Qualitatively assess acceptability to guide future study planning.

OUTLINE: Participants are randomized to 1 of 2 groups.

GRUOP I (MINDFUL MOVEMENT AND BREATHING [eMMB]): Participants receive information about the
intervention individually via telephone and video conference on postoperative day 1 or as
soon as feasible. Participants also have access to a video or written information before
participating in 20 minutes of awareness meditation, gentle movements, and
breathing/relaxation techniques daily for 2 weeks.

GROUP II (ATTENTION CONTROL [AC]): Participants receive caring attention from an
interventionist via telephone or video conference over 30 minutes on postoperative day 1 or
as soon as feasible.

Inclusion Criteria:

- Scheduled for an abdominal gynecological surgery (i.e. uterine, ovarian) to remove a
suspected malignancy.

- 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.
We found this trial at
1
site
1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
Principal Investigator: Stephanie J. Sohl
Phone: 336-713-5093
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
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Winston-Salem, NC
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