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Completed

NCT Number: NCT04298827

Gyn Onc Prehab Study

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Unimodal

Other

Patients will receive physical therapy alone.

Trimodal

Other

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

St. Louis University

Other

Registry information

Official study title

Optimizing Prehabilitation in Gynecologic Oncology

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Mar 6, 2020
Registry last updated
Apr 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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