Status:

ACTIVE_NOT_RECRUITING

Surgery for Cancer With Option of Palliative Care Expert

Lead Sponsor:

Vanderbilt University Medical Center

Conditions:

Cancer

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

Frequently people diagnosed with cancer experience physical and emotional symptoms during the course of their disease. These symptoms can be very distressing to both the patient and the family members...

Detailed Description

The Surgery for Cancer with Option of Palliative Care Expert (SCOPE) Trial is an investigation that will study the effect of a palliative care implementation during the preoperative, perioperative, an...

Eligibility Criteria

Inclusion

  • adult patients (≥18 years old) scheduled for one of the following abdominal operations with intent to provide cure or durable oncologic control of malignancy:
  • Total or partial gastrectomy requiring anastomosis
  • Total or partial pancreatectomy
  • Partial hepatectomy
  • Colectomy or proctactomy if one of the following 3 conditions is also met:
  • i) patient age is 65 years or older ii) disease is metastatic iii) disease is locally invasive requiring extensive resection
  • Radical cystectomy
  • Pelvic exenteration
  • Abdominal debulking for ovarian or endometrial carcinoma
  • Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy

Exclusion

  • Non-English speaking patient
  • Residence \>150 miles away from Vanderbilt and do not visit the Nashville area regularly
  • No telephone or otherwise unwilling/unable to complete follow-ups
  • Prisoner
  • Current enrollment in a study that does not allow co-enrollment or that uses a non-pharmacologic, non-procedural intervention directed at surgical or cancer care.
  • Deaf
  • Severe prior cognitive or neurodegenerative disorder that prevents a patient from living independently at baseline
  • Inability to obtain informed consent from patient meeting all inclusion criteria for the following reasons:
  • Attending surgeon refusal
  • Patient refusal
  • Period of time between screening patient and time of operation does not allow preoperative outpatient palliative care visit.
  • Currently participating in palliative care or seeing a palliative care provider.

Key Trial Info

Start Date :

March 1 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 1 2025

Estimated Enrollment :

236 Patients enrolled

Trial Details

Trial ID

NCT03436290

Start Date

March 1 2018

End Date

November 1 2025

Last Update

January 23 2025

Active Locations (1)

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1

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37232