Gyn Onc Prehab Study

NCT04298827 | Completed

• 1 other identifier: 30334
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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.

  During the approximate 12 week study period

• 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.

  During the approximate 12 week study period

• 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.

  During the approximate 12 week study period

Secondary Outcomes (5)

• Readmission Rates

  During the 8 weeks after surgery (12 week approximate total study period)

• Complication Rates

  During the 12 week approximate total study period

• Patient Satisfaction

  At the conclusion of the approximate 12 week study period

• Quality of Life FACT-G Assessment

  During the 12 week approximate total study period

• Treatment Completion

  At the conclusion of the 12 week approximate total study period

Study Arms (2)

Unimodal

ACTIVE COMPARATOR

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

Trimodal

ACTIVE COMPARATOR

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

Interventions

Unimodal OTHER

Patients will receive physical therapy alone.

Unimodal

Trimodal OTHER

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

Trimodal

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient who will be undergoing a planned surgery for known or presumed gynecologic cancer diagnosis.

You may not qualify if:

• Non-English speaking patients
• Surgeries done for palliative intent
• Poor performance status or other inability to participate in physical therapy

Sponsors & Collaborators

• St. Louis University: lead

Study Sites (1)

Saint Louis University

St Louis, Missouri, 63104, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Endometrial Neoplasms; Uterine Cervical Neoplasms; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Neoplasms; Uterine Diseases; Uterine Cervical Diseases; Health Behavior; Behavior

Study Officials

• Shannon Grabosch, MD

  St. Louis University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Gynecologic Oncology

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: March 6, 2020
• Study Start: July 21, 2020
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: April 8, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)