Clinical trial NCT04298827: Gyn Onc Prehab Study
Official title: Optimizing Prehabilitation in Gynecologic Oncology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gynecologic Cancer
Ovarian Cancer
Endometrial Cancer
Cervical Cancer
Surgery
Treatment Adherence
Quality of Life
Lead sponsor: St. Louis University
Sponsor class: OTHER
First posted: 2020-03-06
Enrollment: 83
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Timed Up and Go
timeFrame: During the approximate 12 week study period
measure: Six Minute Walk Test
timeFrame: During the approximate 12 week study period
measure: Grip Strength
timeFrame: During the approximate 12 week study period
Secondary outcomes:
measure: Readmission Rates
timeFrame: During the 8 weeks after surgery (12 week approximate total study period)
measure: Complication Rates
timeFrame: During the 12 week approximate total study period
measure: Patient Satisfaction
timeFrame: At the conclusion of the approximate 12 week study period
measure: Quality of Life FACT-G Assessment
timeFrame: During the 12 week approximate total study period
measure: Treatment Completion
timeFrame: At the conclusion of the 12 week approximate total study period
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
Study officials:
affiliation: St. Louis University
name: Shannon Grabosch, MD
role: PRINCIPAL_INVESTIGATOR
References: