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

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Fox Chase Cancer Center
Study ID
NCT05454280
Phase
PHASE3
Status
Recruiting
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Conditions

  • Cancer
  • Surgery

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Intensified post-discharge surveillance — PROCEDURE
    * TCC Nurse Televisit at post-discharge day 1 and 7 * Televisit with APP/Resident/Fellow between post-discharge day 3-5 * Referral for home health nursing evaluation upon discharge
  • Standard post-discharge surveillance — PROCEDURE
    Patients in the Control Arm will receive standard post-discharge surveillance, as deemed appropriate/necessary by the surgeons caring for them at the time of hospital discharge.

Study Details

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

Key Dates

Start date
Oct 14, 2022
Status verified
Jul 2025
Primary completion
Nov 1, 2028
Completion
Nov 1, 2028

Study Design

Enrollment
880 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Control Arm: Standard Perioperative Management
    Patients in the Control Arm will receive standard post-discharge surveillance (i.e., usual care).
  • Experimental: Intervention Arm: Intensified Post-Discharge Surveillance
    Patients in the Intervention and Control Arms will be monitored * Through PDD 30 for postoperative deaths and complications (as defined by ACS NSQIP) and/or adverse events (as defined by CTCAE) * Through the end of the index hospitalization for ICU admission, postoperative LOS, return to operating room, and discharge to home. * Through PDD 90 for hospital readmission, QOL, and receipt of anti-neoplastic therapy

Primary Outcome Measure

30-day rate of readmission/visit to emergency department/death [ Time Frame: 30 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Fox Chase Cancer Center - PhiladelphiaPhiladelphiaPennsylvania19111-2497-

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Fox Chase Cancer Center - Philadelphia· Philadelphia, PA

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