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REmotely-delivered Supportive Programs for Improving Surgical Pain and disTrEss
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.
Conditions:
🦠 Postoperative Pain, Acute 🦠 Postoperative Depression 🦠 Anxiety 🦠 Sleep Disturbance 🦠 Malignant Female Reproductive System Neoplasm
🗓️ Study Start (Actual) 13 June 2023
🗓️ Primary Completion (Estimated) 31 August 2026
✅ Study Completion (Estimated) 31 August 2026
👥 Enrollment (Estimated) 160
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE3
Locations:
📍 Charlotte, North Carolina, United States
📍 Winston-Salem, North Carolina, United States

📋 Eligibility Criteria

Description

    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
    • * 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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 14 November 2022
  • First Submitted that Met QC Criteria 14 November 2022
  • First Posted 22 November 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 6 June 2024
  • Last Update Posted 7 June 2024
  • Last Verified June 2024
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