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

ConditionsSurgeryCancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorFox Chase Cancer Center

About this trial

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

Eligibility criteria

Qualifiers

Age > 18 years at diagnosis

ECOG performance status 0, 1, or 2, defined as

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

Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours

Disqualifiers

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.

Post

Elective (curative or palliative) major cancer surgery (as listed in 4.1.4 above) at the time of the index surgery (patient may have undergone more than one of these procedures) OR

Elective surgical procedure(s) listed as an option (i.e., CPT code) in the Surgical Risk Calculator webpage (patient may have undergone more than one of these procedures)

Trial design

Treatments tested in this trial

  • Intensified post-discharge surveillance
  • Standard post-discharge surveillance

Treatment groups

880 Participants
are divided into 2 treatment groups

Sponsors and collaborators