Supportive Care Intervention-Pancreas

Not Applicable

Completed

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
trial feasibility	up to 2 years	We will assess trial feasibility by monitoring number of eligible patients per clinic day, contact rates, interest rates, enrollment rates, randomization rates, intervention visit completion rates, and outcome assessment completion rates.
acceptability of intervention participation	3 months (+/- 3 weeks) from patient enrollment	We will report the percentage of patients and caregivers who found the intervention acceptable.
intervention fidelity	Up to 2 years	We will use post-visit checklists to characterize the number and types of recommended topics covered during each supportive care intervention visit.
perceived effectiveness	3 months (+/- 3 weeks) from patient enrollment	We will report the percentage of patients and caregivers who perceived the intervention to be effective for treating symptoms, understanding their illness, coping, and planning for the future.

Secondary Outcome Measures

Name	Time	Method
change in patient quality of life	baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment	We will summarize range and distribution of change in patient quality of life from baseline to 3 months using the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep). Because this is a pilot trial, we will not conduct formal tests of efficacy.
patient healthcare utilization	up to 2 years	We will summarize range and distribution of the following patient healthcare utilization outcomes: number and types of chemotherapy regimens, frequency and timing of chemotherapy regimens, number and length (days) of hospital admissions, number and length (days) of ICU admissions, number of emergency department visits, frequency and timing (days before death) of hospice use, place of death. Because this is a pilot trial, we will not conduct formal tests of efficacy.
patient quality of life	3 months (+/- 3 weeks) from patient enrollment	We will summarize range and distribution of patient quality of life at 3 months using the FACT-Hep scale. Because this is a pilot trial, we will not conduct formal tests of efficacy.

Locations (1): University of Pittsburgh Cancer Institute (UPCI), Hillman Cancer Center
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Pittsburgh, Pennsylvania, United States