Supportive Care Intervention-Pancreas (SCI-P)

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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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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