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NCT04298827 | COMPLETED | Gynecologic Cancer


Gyn Onc Prehab Study
Sponsor:

St. Louis University

Information provided by (Responsible Party):

Shannon Grabosch, MD

Brief Summary:

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

Condition or disease

Gynecologic Cancer

Ovarian Cancer

Endometrial Cancer

Cervical Cancer

Surgery

Treatment Adherence

Quality of Life

Intervention/treatment

Unimodal

Trimodal

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 83 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
Official Title : Optimizing Prehabilitation in Gynecologic Oncology
Actual Study Start Date : 2020-07-21
Estimated Primary Completion Date : 2024-03-01
Estimated Study Completion Date : 2024-03-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 90 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: 1
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

Gyn Onc Prehab Study

Location Details

NCT04298827


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Locations


Not yet recruiting

United States, Missouri

Saint Louis University

Saint Louis, Missouri, United States, 63104

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