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NCT04204811 Clinical Trial

Prehabilitation Care for Women With Advanced Ovarian Cancer Receiving Neoadjuvant Chemotherapy

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04204811
Other study ID # 19-347
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date December 16, 2019
Est. completion date December 16, 2024

Study information
Verified date March 2024
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 22
Est. completion date December 16, 2024
Est. primary completion date December 16, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States Memorial Sloan Kettering Cancer Center New York New York

Sponsors (1)
Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Median completion of participants Study will be considered feasible if the cohort has a median completion of 70% or more Up to 1 year
See also
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