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NCT05625360
REmotely-delivered Supportive Programs for Improving Surgical Pain and disTrEss
Conditions: Postoperative Pain, Acute, Postoperative Depression, Anxiety, Sleep Disturbance, Malignant Female Reproductive System Neoplasm
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: PHASE3
Enrollment: 160
Sponsor: Wake Forest University Health Sciences
Location: Atrium Health - Levine Cancer Institute Charlotte North Carolina
Summary
The purpose of this research study is to learn how two different supportive programs may help women feel better after surgery. This study will measure if one type of supportive program is more useful than the other for improving wellbeing after surgery.
Eligibility Criteria
Inclusion Criteria:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
* Provision of signed and dated informed consent form
* Participants age 18 years and older at time of consent.
* 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
* Able to understand, read and write English (since the intervention is conducted in English)
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
* Presence of a psychotic disorder, current suicidal ideation, or other unstable major psychiatric condition documented by diagnosis in the medical chart.
* Unwillingness or inability to follow study procedures
Source: ClinicalTrials.gov (NCT05625360). StuddyBuddy aggregates publicly available trial information.