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Prehabilitation Care for Women With Advanced Ovarian Cancer Receiving Neoadjuvant Chemotherapy

Sponsor
Memorial Sloan Kettering Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04204811
Collaborator
(none)
30
Enrollment
1
Location
60
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Prehabilitation

Study Design

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Pilot Project to Evaluate Feasibility and Patient Experience of Prehabilitation Care for Women With Advanced Ovarian Cancer Undergoing Neoadjuvant Chemotherapy
Actual Study Start Date :
Dec 16, 2019
Anticipated Primary Completion Date :
Dec 16, 2024
Anticipated Study Completion Date :
Dec 16, 2024

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Median completion of participants [Up to 1 year]

    Study will be considered feasible if the cohort has a median completion of 70% or more

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Memorial Sloan Kettering Cancer Center New York New York United States 10065

Sponsors and Collaborators

  • Memorial Sloan Kettering Cancer Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT04204811
Other Study ID Numbers:
  • 19-347
First Posted:
Dec 19, 2019
Last Update Posted:
Jul 6, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Memorial Sloan Kettering Cancer Center
Ovarian Cancer
Primary peritoneal carcinoma
Fallopian tube cancer
19-347
Memorial Sloan Kettering Cancer Center
Additional relevant MeSH terms:
Carcinoma
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Fallopian Tube Neoplasms

Study Results

No Results Posted as of Jul 6, 2022