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Clinical Trials/NCT04204811
NCT04204811Active, not recruitingNot Applicable

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 enrollmentStarted: December 16, 2019Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
22
Locations
1
Primary Endpoint
Median completion of participants
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Experimental

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

Intervention: Prehabilitation (Other)

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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