Gyn Onc Prehab Study

• ClinicalTrials.gov Identifier: NCT04298827
• Recruitment Status: Recruiting
• First Posted: March 6, 2020
• Last Update Posted: April 15, 2022
• Sponsor: St. Louis University
• Information provided by (Responsible Party): Shannon Grabosch, MD, St. Louis University

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Gynecologic Cancer; Ovarian Cancer; Endometrial Cancer; Cervical Cancer; Surgery; Treatment Adherence; Quality of Life	Other: Unimodal; Other: Trimodal	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 164 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Optimizing Prehabilitation in Gynecologic Oncology
• Actual Study Start Date: July 21, 2020
• Estimated Primary Completion Date: March 2024
• Estimated Study Completion Date: March 2024

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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.	Other: Unimodal; Patients will receive physical therapy alone.
Active Comparator: 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.	Other: Trimodal; Patients will receive physical therapy, nutrition counseling, and cognitive behavioral therapy in the form of group counseling.

Outcome Measures

Primary Outcome Measures :

1. Timed Up and Go [ 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.
2. Six Minute Walk Test [ 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.
3. Grip Strength [ 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.

Secondary Outcome Measures :

1. Readmission Rates [ Time Frame: During the 8 weeks after surgery (12 week approximate total study period) ]
   Need for postoperative readmission with be monitored in each group.
2. Complication Rates [ Time Frame: During the 12 week approximate total study period ]
   Surgical or treatment complications with be monitored in each group.
3. Patient Satisfaction [ 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.
4. Quality of Life FACT-G Assessment [ 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).
5. Treatment Completion [ Time Frame: At the conclusion of the 12 week approximate total study period ]
   Rate of program completion will be assessed for each group.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Contacts

Contact: Shannon Grabosch, MD; 3147818605 ext 1; shannon.grabosch@health.slu.edu

Contact: Shohreh Jamalabadi-Majidi, DMD, MPH; 314-977-7482; shohreh.jamalabadimajidi@health.slu.edu

Locations

United States, Missouri

Saint Louis University; Recruiting

Saint Louis, Missouri, United States, 63104

Contact: Shannon Grabosch, MD 314-781-8605 ext 1 shannon.grabosch@health.slu.edu

Sponsors and Collaborators

St. Louis University

Investigators

• Principal Investigator: Shannon Grabosch, MD; St. Louis University

More Information

• Responsible Party: Shannon Grabosch, MD, Assistant Professor of Gynecologic Oncology, St. Louis University
• ClinicalTrials.gov Identifier: NCT04298827
• Other Study ID Numbers: 30334
• First Posted: March 6, 2020
• Last Update Posted: April 15, 2022
• Last Verified: April 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Data will not be shared outside of members of the research team.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Endometrial Neoplasms; Neoplasms by Site; Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Neoplasms; Uterine Diseases