RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2022-10-14

Study Completion:2028-11-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05454280

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Jason Castellanos, MD

CONTACT

215-728-3518

Jason.Castellanos@fccc.edu

Principal Investigator

Jason Castellanos, MD

PRINCIPAL_INVESTIGATOR

Fox Chase Cancer Center

Study Locations (Sites)

Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, 19111-2497

United States

Collaborators and Investigators

Sponsor: Fox Chase Cancer Center

Jason Castellanos, MD, PRINCIPAL_INVESTIGATOR, Fox Chase Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-14

Study Completion Date2028-11-01

Study Record Updates

Study Start Date2022-10-14

Study Completion Date2028-11-01

Terms related to this study

Additional Relevant MeSH Terms

Surgery
Cancer