Brief Title
Gyn Onc Prehab Study
Official Title
Optimizing Prehabilitation in Gynecologic Oncology
Brief 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.
Study Type
Interventional
Primary Outcome
Timed Up and Go
Secondary Outcome
Readmission Rates
Condition
Gynecologic Cancer
Intervention
Unimodal
Study Arms / Comparison Groups
Unimodal
Description: Patients will be randomized at their pre-surgical consultation. Patients will undergo a physical therapy evaluation prior to surgery and at 4 and 8 weeks post-op. Their preoperative visits will be as close to 4 weeks before surgery as possible but given the urgency of some of these surgeries and diagnoses, treatment will not be delayed to complete the components of this study. The patient will also be asked to complete a quality of life assessment at the beginning and end of the study as well as an anonymous survey at the conclusion of the study evaluating her satisfaction with the experiment.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
164
Start Date
July 21, 2020
Completion Date
March 2024
Primary Completion Date
March 2024
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
Gender
Female
Ages
18 Years - 90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Shannon Grabosch, MD, 3147818605, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT04298827
Organization ID
30334
Responsible Party
Principal Investigator
Study Sponsor
St. Louis University
Study Sponsor
Shannon Grabosch, MD, Principal Investigator, St. Louis University
Verification Date
April 2022