Clinical trial NCT03681405: Supportive Programs for Supporting Optimal Recovery in Participants Undergoing Gynecological Surgery
Official title: Support for Optimal Recovery Following Gynecologic Surgery Study (SOARING)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ovarian Neoplasm
Uterine Neoplasm
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-09-24
Enrollment: 31
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

GROUP I (MINDFUL MOVEMENT AND BREATHING \[eMMB\]): Participants will receive instruction on awareness meditation, breathing and relaxation, and awareness meditation. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants will also be given a self-directed video to be used before surgery and daily for two weeks following surgery.

GROUP II (ATTENTION CONTROL \[AC\]): Participants will receive caring attention. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants are also asked to write brief diary entries once before surgery and daily for two weeks following surgery.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants Retained in the Study
timeFrame: Up to 2 weeks
measure: Percentage of Participants That Were Adhered to the Intervention
timeFrame: Up to 5 weeks
Secondary outcomes:
measure: Change in Pain Intensity Per Patient Reported Outcomes Measurement Information System (PROMIS)
timeFrame: Baseline, 2 weeks and 4 weeks
measure: Change in Affective Dimension of Pain
timeFrame: Baseline, 2 weeks and 4 weeks
measure: Change in Pain Interference Per PROMIS Measure
timeFrame: Baseline, 2 weeks and 4 weeks
measure: Change in Sleep Disturbances Per PROMIS Sleep Disturbance Short-form
timeFrame: Baseline, 2 weeks and 4 weeks
measure: Change in Psychological Distress Per PROMIS Depression
timeFrame: Baseline, 2 weeks and 4 weeks
measure: Change in Psychological Distress Per PROMIS Anxiety
timeFrame: Baseline, 2 weeks and 4 weeks
measure: Incidence of Adverse Events Per Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
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: