Prehabilitation Care for Women With Advanced Ovarian Cancer Receiving Neoadjuvant Chemotherapy

March 29, 2024 updated by: Memorial Sloan Kettering Cancer Center

A Pilot Project to Evaluate Feasibility and Patient Experience of Prehabilitation Care for Women With Advanced Ovarian Cancer Undergoing Neoadjuvant Chemotherapy

The purpose of this study is evaluate whether a prehabilitation program is feasible and useful for women with advanced ovarian cancer receiving chemotherapy in preparation for debulking surgery.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

22

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: William Tew, MD
  • Phone Number: 646-888-4220
  • Email: teww@MSKCC.ORG

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants will be recruited from female patients identified by Gynecologic Medical Oncology as appropriate for inclusion.

Description

Inclusion Criteria:

  • Subjects must be diagnosed with Stage III or Stage IV ovarian carcinoma (which includes primary peritoneal carcinoma or fallopian rube carcinoma)
  • All subjects must be enrolled within 90 days of diagnosis
  • No prior treatment for ovarian carcinoma
  • All subjects have agreed to a treatment plan of neoadjuvant chemotherapy and subsequent planned interval debulking surgery with an MSKCC surgeon
  • Participants must be initiating treatment at Gynecologic Medical Oncology clinics at MSKCC Manhattan
  • Proficiency in English in the determination of the investigators of by patient self-report

Exclusion Criteria:

  • Patient under age 18
  • Prior treatment for ovarian cancer
  • Second opinion visit only
  • Immediate surgery plan without neoadjuvant treatment
  • No intended surgical plan
  • Chemotherapy administration exclusively planned at MSKCC regional site
  • Patient unwilling to sign consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants with Ovarian Cancer
Participants are diagnosed with Stage III or Stage IV ovarian carcinoma (which includes primary peritoneal carcinoma or fallopian tube carcinoma)
Other: Prehabilitation
A program of personalized independent home exercises are outline for participants to complete daily. Prehabilitation coaching will continue weekly until admission for surgical tumor debulking or termination of neoadjuvant treatment for any reason.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Median completion of participants
Time Frame: Up to 1 year
Study will be considered feasible if the cohort has a median completion of 70% or more
Up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Theresa Gillis, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 16, 2019

Primary Completion (Estimated)

December 16, 2024

Study Completion (Estimated)

December 16, 2024

Study Registration Dates

First Submitted

December 17, 2019

First Submitted That Met QC Criteria

December 17, 2019

First Posted (Actual)

December 19, 2019

Study Record Updates

Last Update Posted (Actual)

April 1, 2024

Last Update Submitted That Met QC Criteria

March 29, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-347

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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