Ovarian Cancer Clinical Trial

Gyn Onc Prehab Study

Summary

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

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Full 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.

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Eligibility Criteria

Inclusion Criteria:

Patient who will be undergoing a planned surgery for known or presumed gynecologic cancer diagnosis.

Exclusion Criteria:

Non-English speaking patients
Surgeries done for palliative intent
Poor performance status or other inability to participate in physical therapy

Study is for people with:

Ovarian Cancer

Estimated Enrollment:

164

Study ID:

NCT04298827

Recruitment Status:

Recruiting

Sponsor:

St. Louis University

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There is 1 Location for this study

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Saint Louis University
Saint Louis Missouri, 63104, United States More Info
Shannon Grabosch, MD
Contact
314-781-8605
[email protected]

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Study is for people with:

Ovarian Cancer

Estimated Enrollment:

164

Study ID:

NCT04298827

Recruitment Status:

Recruiting

Sponsor:


St. Louis University

How clear is this clinincal trial information?

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