RECRUITING

Post-Discharge Risk-Based Management in Patients Undergoing High-Risk Elective Major Cancer Operations (PRS II)

Description

This is a randomized trial of intensified post-discharge surveillance (Intervention Arm) versus standard post-discharge surveillance (Control Arm).

Conditions

Study Overview

Study Details

Study overview

This is a randomized trial of intensified post-discharge surveillance (Intervention Arm) versus standard post-discharge surveillance (Control Arm).

A Randomized Controlled Trial of Post-Discharge Risk-Based Management in Patients Undergoing High-Risk Elective Major Cancer Operations (PRS II)

Post-Discharge Risk-Based Management in Patients Undergoing High-Risk Elective Major Cancer Operations (PRS II)

Condition
Surgery
Intervention / Treatment

-

Contacts and Locations

Philadelphia

Fox Chase Cancer Center - Philadelphia, Philadelphia, Pennsylvania, United States, 19111-2497

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Age \> 18 years at diagnosis
  • * ECOG performance status 0, 1, or 2, defined as
  • 1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work
  • 2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours
  • * Patients must have probable (i.e., clinically suspicious) or histologically/cytologically confirmed, primary or recurrent, malignant neoplasm, malignant neuroendocrine tumor, or carcinoma in situ (any stage).
  • * Patient must be scheduled for elective major cancer surgery (as listed in 4.1.4) at FCCC \< 30 days after First Registration.
  • * Patient is scheduled to be brought from their home (or normal living environment) to FCCC on the day of the index surgery (or day prior as scheduled admission) AND
  • * Surgery is not scheduled as urgent or emergent
  • * Ability to understand and willingness to sign a written informed consent and HIPAA consent document
  • * Geographical accessibility and willingness to return to FCCC for all preoperative and postoperative study assessments.
  • * Any condition that might interfere with the subject's participation in the study, compliance with study requirements, or in the evaluation of the study results.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Fox Chase Cancer Center,

Jason Castellanos, MD, PRINCIPAL_INVESTIGATOR, Fox Chase Cancer Center

Study Record Dates

2028-11-01