Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07865052 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Psychological Prehabilitation for Complex Gastrointestinal Surgery

Study acronym: PREPARE-GI
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Secondary endpoints: details revised at 1 of 10 entries
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
3,263 trials monitored
See 159 trials at risk
3,055 trials monitored
See 173 trials at risk
889 trials monitored
See 54 trials at risk
The goal of this clinical trial is to learn if a psychological program before surgery can help adults who have lasting stress from past medical experiences. The program is called PREPARE-GI. It is for adults having planned, complex surgery on the digestive system, also called gastrointestinal (GI) surgery. Many people who need complex GI surgery have been through a lot. They may have had many surgeries, hospital stays, or emergency visits. These experiences can leave lasting stress, worry, and low mood. These feelings can make recovery from surgery harder. The main questions this study aims to answer are: * Can researchers sign up enough participants, and will participants attend the program sessions and finish the surveys? * Does the program lower stress, worry (anxiety), and low mood (depression)? * Does the program lower pain and improve quality of life after surgery? * Does the program shorten hospital stays or lower return visits to the hospital or emergency room? Researchers will compare two groups. One group will take part in the PREPARE-GI program. The other group will get usual surgical care. Participants will be placed in a group by chance, like flipping a coin. Adults may be able to join if they: Are 18 or older Have complex GI surgery planned at Northwestern Memorial Hospital at least 8 weeks away Score high on a short survey about stress from past experiences Can complete the study in English All participants will: Answer survey questions about stress, worry, mood, body symptoms, pain, and quality of life. They will do this before surgery, then 1 month and 3 months after surgery. The surveys will take about 20 to 30 minutes to complete. Rate their pain on a scale from 0 to 10 after surgery. Allow researchers to review their medical records for information about their surgery and recovery. Participants in the program group will also meet one-on-one with a licensed psychologist for 8 sessions. Each session lasts about 1 hour and will take place either in person or by secure video from home. In the sessions, participants will learn skills to manage stress, handle difficult feelings, and prepare for surgery and recovery. Participants will be in the study for about 5 months. Participants in the program group will spend about 9 to 10 hours on the study. Participants in the usual care group will spend about 1 to 1.5 hours. This is a small study with 20 participants. The results will help researchers plan a larger study in the future.
Trial Details
NCT Number NCT07865052
Lead Sponsor Northwestern University
Conditions
(from sponsor)
Post-traumatic Stress Symptoms, Anxiety, Depression Disorder, Gastrointestinal Disease
Related terms Anxiety Disorders, Gastrointestinal Diseases
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov