Gyn Onc Prehab Study

Quality of Life Clinical Trial

Official title:

Optimizing Prehabilitation in Gynecologic Oncology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04298827
• Other study ID #: 30334
• Status: Completed
• Phase: N/A
• Start date: July 21, 2020
• Est. completion date: March 1, 2024

Study information

• Verified date: April 2024
• Source: St. Louis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: March 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Endometrial Cancer
• Endometrial Neoplasms
• Gynecologic Cancer
• Ovarian Cancer
• Quality of Life
• Surgery
• Treatment Adherence

Intervention

Other:
• Unimodal
Patients will receive physical therapy alone.
• Trimodal
Patients will receive physical therapy, nutrition counseling, and cognitive behavioral therapy in the form of group counseling.

Locations

Country	Name	City	State
United States	Saint Louis University	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
St. Louis University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Timed Up and Go	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.	During the approximate 12 week study period
Primary	Six Minute Walk Test	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.	During the approximate 12 week study period
Primary	Grip Strength	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.	During the approximate 12 week study period
Secondary	Readmission Rates	Need for postoperative readmission with be monitored in each group.	During the 8 weeks after surgery (12 week approximate total study period)
Secondary	Complication Rates	Surgical or treatment complications with be monitored in each group.	During the 12 week approximate total study period
Secondary	Patient Satisfaction	Patients from each group will be asked to complete an anonymous survey evaluating their satisfaction with the program.	At the conclusion of the approximate 12 week study period
Secondary	Quality of Life FACT-G Assessment	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).	During the 12 week approximate total study period
Secondary	Treatment Completion	Rate of program completion will be assessed for each group.	At the conclusion of the 12 week approximate total study period