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Clinical Trials/NCT04204811
NCT04204811
Active, Not Recruiting
N/A

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

Memorial Sloan Kettering Cancer Center1 site in 1 country22 target enrollmentDecember 16, 2019
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ConditionsOvarian CancerStage III Ovarian CancerStage IV Ovarian CancerPrimary Peritoneal CarcinomaFallopian Tube CarcinomaFallopian Tube Cancer
InterventionsPrehabilitation

Overview

Phase
N/A
Intervention
Prehabilitation
Conditions
Ovarian Cancer
Sponsor
Memorial Sloan Kettering Cancer Center
Enrollment
22
Locations
1
Primary Endpoint
Median completion of participants
Status
Active, Not Recruiting
Last Updated
3 months ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
December 16, 2019
End Date
December 16, 2026
Last Updated
3 months ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

Participants with Ovarian Cancer

Participants are diagnosed with Stage III or Stage IV ovarian carcinoma (which includes primary peritoneal carcinoma or fallopian tube carcinoma)

Intervention: Prehabilitation

Outcomes

Primary Outcomes

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

Study Sites (1)

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