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Prehabilitation for Gynecologic Cancers

N/A
Waitlist Available
Led By Shannon Grabosch, MD
Research Sponsored by St. Louis University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient who will be undergoing a planned surgery for known or presumed gynecologic cancer diagnosis.
Patient who will be undergoing a planned surgery for known or presumed gynecologic cancer diagnosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during the 8 weeks after surgery (12 week approximate total study period)
Awards & highlights

Study Summary

This trial is testing whether a pre-surgery program can improve outcomes for gynecologic cancer patients.

Who is the study for?
This trial is for English-speaking individuals scheduled for surgery due to known or suspected gynecologic cancers, such as ovarian, cervical, and endometrial cancers. Participants should be able to engage in physical therapy; those with poor performance status or surgeries intended solely for comfort care are excluded.Check my eligibility
What is being tested?
The study is examining the effectiveness of two pre-surgery programs (unimodal vs. trimodal) aimed at improving patients' fitness and overall quality of life before they undergo surgery for various gynecologic cancers.See study design
What are the potential side effects?
Since this trial involves prehabilitation programs rather than drugs, side effects may include typical exercise-related issues like muscle soreness or fatigue but will vary based on individual health conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am scheduled for surgery for a gynecologic cancer diagnosis.
Select...
I am scheduled for surgery for a gynecologic cancer diagnosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during the 8 weeks after surgery (12 week approximate total study period)
This trial's timeline: 3 weeks for screening, Varies for treatment, and during the 8 weeks after surgery (12 week approximate total study period) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Grip Strength
Six Minute Walk Test
Timed Up and Go
Secondary outcome measures
Complication Rates
Patient Satisfaction
Quality of Life FACT-G Assessment
+2 more

Trial Design

2Treatment groups
Active Control
Group I: UnimodalActive Control1 Intervention
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 II: TrimodalActive Control1 Intervention
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.

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Who is running the clinical trial?

St. Louis UniversityLead Sponsor
194 Previous Clinical Trials
43,572 Total Patients Enrolled
1 Trials studying Gynecologic Cancers
120 Patients Enrolled for Gynecologic Cancers
Shannon Grabosch, MDPrincipal Investigator - St. Louis University
SSM St. Mary's Health Center, St. Louis University Hospital, St. Luke's Hospital
1 Previous Clinical Trials
120 Total Patients Enrolled
1 Trials studying Gynecologic Cancers
120 Patients Enrolled for Gynecologic Cancers

Media Library

Unimodal Clinical Trial Eligibility Overview. Trial Name: NCT04298827 — N/A
Gynecologic Cancers Research Study Groups: Unimodal, Trimodal
Gynecologic Cancers Clinical Trial 2023: Unimodal Highlights & Side Effects. Trial Name: NCT04298827 — N/A
Unimodal 2023 Treatment Timeline for Medical Study. Trial Name: NCT04298827 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical trial open to minors?

"This study stipulates that participants must be aged 18 or older, but no more than 90 years old."

Answered by AI

How many participants is the maximum capacity for this medical experiment?

"Affirmative. According to information available on clinicaltrials.gov, recruitment for this medical trial is underway; it was initially posted on July 21st 2020 and most recently adjusted on April 14th 2022. A total of 164 patients are required across 1 location in order to complete the study."

Answered by AI

Does my background qualify me to participate in this experimental research?

"In order to be eligible for the trial, individuals must meet two criteria: they must maintain treatment compliance and their age should fall between 18 - 90. Thus far, 164 people have been accepted into this experimental program."

Answered by AI

Are registrants currently being accepted for this clinical investigation?

"Affirmative. The clinicaltrials.gov database confirms the ongoing recruitment of 164 patients at a single site for this medical trial, which was originally listed on July 21st 2020 and updated most recently on April 14th 2022."

Answered by AI

What major goals is this research endeavor attempting to accomplish?

"The focal point of this study over the 12 week period is to quantify Grip Strength, while other metrics such as Need for Postoperative Readmission and Rate of Program Completion are also being assessed. In addition, Quality of Life will be monitored using the FACT-G (Functional Assessment of Cancer Therapy-General), which consists of 28 questions that generate a score between 0 and 112 with higher scores correlating to better quality life."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Gyn Onc Prehab Study
Shannon Grabosch, MD 2020. "Gyn Onc Prehab Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04298827.
~18 spots leftby Apr 2025
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