Gyn Onc Prehab Study

NCT ID: NCT04298827

Last Updated: 2024-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-21
• Study Completion Date: 2024-03-01

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.

Conditions

Gynecologic Cancer; Ovarian Cancer; Endometrial Cancer; Cervical Cancer; Surgery; Treatment Adherence; Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Unimodal

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.

Group Type: ACTIVE_COMPARATOR

Unimodal

Intervention Type: OTHER

Patients will receive physical therapy alone.

Trimodal

Patients will be randomized at their pre-surgical consultation. Patients will undergo a physical therapy evaluation, nutritional counseling and group therapy, 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. Patient nutritional assessments will be obtained with Patient Generated Subjective Global Assessment questionnaires as well as targeted questioning by the dietician.

Group Type: ACTIVE_COMPARATOR

Trimodal

Intervention Type: OTHER

Patients will receive physical therapy, nutrition counseling, and cognitive behavioral therapy in the form of group counseling.

Interventions

Unimodal

Patients will receive physical therapy alone.

Intervention Type: OTHER

Trimodal

Patients will receive physical therapy, nutrition counseling, and cognitive behavioral therapy in the form of group counseling.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

St. Louis University

OTHER

Sponsor Role: lead

Responsible Party

Shannon Grabosch, MD

Assistant Professor of Gynecologic Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shannon Grabosch, MD

Role: PRINCIPAL_INVESTIGATOR

St. Louis University

Locations

Saint Louis University

St Louis, Missouri, United States

Countries

United States

Other Identifiers

30334

Identifier Type: -

Identifier Source: org_study_id