NCT04298827

Gyn Onc Prehab Study

Optimizing Prehabilitation in Gynecologic Oncology

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: St. Louis University · Academic / Other
• Sex: Female
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

Summary

Patients will be randomized to a unimodal or trimodal prehabilitation program prior to surgery for known or suspected gynecologic cancer.

Detailed description

Prehabilitation generally refers to the act of an intervention prior to a known potentially debilitating event. Usually taking the form of physical therapy prior to surgery, prehabilitation programs have demonstrated success in colorectal, urological, and surgical oncology cases. Patients with a gynecologic oncology diagnosis face an arduous course. Their treatment generally involves a major surgery and is often followed by chemotherapy, radiation, or both.The patient population is generally older in life as the average age for an endometrial or ovarian cancer diagnosis is 63. These patients may already have a lower performance status at baseline deeming their treatment course exponentially more difficult to endure. Women with gynecologic cancer suffer significant mental duress often living in fear of the high rates of recurrence from some of these malignancies suggesting they may benefit from psychologic support and counseling through their treatment. Given the proven success in other surgical disciplines, we believe that instituting prehabilitation programs should be standard of care. Patients will be randomized to a trimodal approach (physical therapy, nutritional counseling, cognitive behavioral therapy) versus a unimodal intervention (physical therapy) for a formal prehabilitation program. Our primary outcome will be functional return to baseline following surgery with secondary outcomes including items such as quality of life assessments, patient satisfaction, and compliance.

Conditions

• Gynecologic Cancer
• Ovarian Cancer
• Endometrial Cancer
• Cervical Cancer
• Surgery
• Treatment Adherence
• Quality of Life

Interventions

Type	Name	Description
OTHER	Unimodal	Patients will receive physical therapy alone.
OTHER	Trimodal	Patients will receive physical therapy, nutrition counseling, and cognitive behavioral therapy in the form of group counseling.

Timeline

• Start date: 2020-07-21
• Primary completion: 2024-03-01
• Completion: 2024-03-01
• First posted: 2020-03-06
• Last updated: 2024-04-08

Locations

1 site across 1 country: United States