Supportive Care Intervention-Pancreas (SCI-P)

University of Pittsburgh

Status: Completed

Conditions: Advanced Pancreatic Cancer

Treatments: Behavioral: Embedded Supportive Care

Study type: Interventional

Funder types: Other

Identifiers

NCT01885884

PRO13020507

Details and patient eligibility

About

This is a pilot, randomized controlled trial of an embedded collaborative model of supportive care designed to improve quality of life and decrease use of unwanted healthcare services at the end of life for patients with advanced pancreatic cancer. We will enroll 30 patients who are receiving treatment at the Hillman Cancer Center for recently diagnosed, locally advanced or metastatic pancreatic adenocarcinoma, as well as their accompanying caregivers and providers. Patients will be randomized to receive either the supportive care intervention or usual care. The purpose of this study is to refine an embedded collaborative model of supportive care and to develop protocols for recruitment, randomization, and longitudinal data collection.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients:

  • Adults (≥ 18 years old)
  • Pathologically-confirmed locally advanced or metastatic pancreatic adenocarcinoma diagnosed within the past 8 weeks
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 (asymptomatic), 1 (symptomatic but fully ambulatory), or 2 (symptomatic and in bed <50% of the day)
  • Planning to receive continued care from an oncologist at the Hillman Cancer Center
  • Accompanied by a caregiver (family member or friend) at the first visit

• Caregivers:

  • Adults (>= 18 years old)
  • Family member or friend of an eligible patient

Exclusion criteria

• Patients:

  • Unable to read and respond to questions in English
  • Not planning to receive continued care from an oncologist at the Hillman Cancer Center
  • Pancreatic neuroendocrine cancer

• Caregivers:

  • Unable to read and respond to questions in English

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 2 patient groups

Supportive Care Intervention

Experimental group

Description:

Monthly (minimum) patient & caregiver visits with a Supportive Care physician, embedded within their standard oncological care (through collaboration with oncology providers).

Treatment:

Behavioral: Embedded Supportive Care

Usual Care

No Intervention group

Description:

Participants will receive standard oncology care from their oncology providers.