Saint Louis University
St Louis, Missouri, 63104, United States
NCT Number: NCT04298827
Patients will be randomized to a unimodal or trimodal prehabilitation program prior to surgery for known or suspected gynecologic cancer.
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Notify Me18 year–90 year
Female
Interventional
Not applicable
St Louis, Missouri, 63104, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will receive physical therapy alone.
Patients will receive physical therapy, nutrition counseling, and cognitive behavioral therapy in the form of group counseling.
Time frame: During the approximate 12 week study period
Patients will have a preoperative physical therapy assessment incorporating standard evaluations of a 6 minute walk test, grip strength, and timed up and go. These will serve as the individual patient's baseline for subsequent comparison after surgery.
Time frame: During the approximate 12 week study period
Patients will have a preoperative physical therapy assessment incorporating standard evaluations of a 6 minute walk test, grip strength, and timed up and go. These will serve as the individual patient's baseline for subsequent comparison after surgery.
Time frame: During the approximate 12 week study period
Patients will have a preoperative physical therapy assessment incorporating standard evaluations of a 6 minute walk test, grip strength, and timed up and go. These will serve as the individual patient's baseline for subsequent comparison after surgery.
Time frame: During the 8 weeks after surgery (12 week approximate total study period)
Need for postoperative readmission with be monitored in each group.
Time frame: During the 12 week approximate total study period
Surgical or treatment complications with be monitored in each group.
Time frame: At the conclusion of the approximate 12 week study period
Patients from each group will be asked to complete an anonymous survey evaluating their satisfaction with the program.
Time frame: During the 12 week approximate total study period
Patients will complete baseline and follow up quality of life assessments using the FACT-G (Functional Assessment of Cancer Therapy-General). This is a 28 question quality of life assessment with scores ranging from 0 to 112 (higher scores correlate with a higher quality of life).
Time frame: At the conclusion of the 12 week approximate total study period
Rate of program completion will be assessed for each group.
St. Louis University
Other
Optimizing Prehabilitation in Gynecologic Oncology
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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