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Gyn Onc Prehab Study

Primary Purpose

Gynecologic Cancer, Ovarian Cancer, Endometrial Cancer

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Unimodal
Trimodal
Sponsored by
St. Louis University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Gynecologic Cancer

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Saint Louis University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Unimodal

Trimodal

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Readmission Rates
Need for postoperative readmission with be monitored in each group.
Complication Rates
Surgical or treatment complications with be monitored in each group.
Patient Satisfaction
Patients from each group will be asked to complete an anonymous survey evaluating their satisfaction with the program.
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).
Treatment Completion
Rate of program completion will be assessed for each group.

Full Information

First Posted
March 2, 2020
Last Updated
September 8, 2023
Sponsor
St. Louis University
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1. Study Identification

Unique Protocol Identification Number
NCT04298827
Brief Title
Gyn Onc Prehab Study
Official Title
Optimizing Prehabilitation in Gynecologic Oncology
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 21, 2020 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Louis University

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gynecologic Cancer, Ovarian Cancer, Endometrial Cancer, Cervical Cancer, Surgery, Treatment Adherence, Quality of Life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Unimodal
Arm Type
Active Comparator
Arm 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.
Arm Title
Trimodal
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Unimodal
Intervention Description
Patients will receive physical therapy alone.
Intervention Type
Other
Intervention Name(s)
Trimodal
Intervention Description
Patients will receive physical therapy, nutrition counseling, and cognitive behavioral therapy in the form of group counseling.
Primary Outcome Measure Information:
Title
Timed Up and Go
Description
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.
Time Frame
During the approximate 12 week study period
Title
Six Minute Walk Test
Description
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.
Time Frame
During the approximate 12 week study period
Title
Grip Strength
Description
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.
Time Frame
During the approximate 12 week study period
Secondary Outcome Measure Information:
Title
Readmission Rates
Description
Need for postoperative readmission with be monitored in each group.
Time Frame
During the 8 weeks after surgery (12 week approximate total study period)
Title
Complication Rates
Description
Surgical or treatment complications with be monitored in each group.
Time Frame
During the 12 week approximate total study period
Title
Patient Satisfaction
Description
Patients from each group will be asked to complete an anonymous survey evaluating their satisfaction with the program.
Time Frame
At the conclusion of the approximate 12 week study period
Title
Quality of Life FACT-G Assessment
Description
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).
Time Frame
During the 12 week approximate total study period
Title
Treatment Completion
Description
Rate of program completion will be assessed for each group.
Time Frame
At the conclusion of the 12 week approximate total study period

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shannon Grabosch, MD
Organizational Affiliation
St. Louis University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saint Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States

12. IPD Sharing Statement

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

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Gyn Onc Prehab Study

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