Supportive Care Intervention-Pancreas

University of Pittsburgh60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Advanced Pancreatic Cancer

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

trial feasibility

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.

Time frame: up to 2 years

acceptability of intervention participation

We will report the percentage of patients and caregivers who found the intervention acceptable.

Time frame: 3 months (+/- 3 weeks) from patient enrollment

intervention fidelity

We will use post-visit checklists to characterize the number and types of recommended topics covered during each supportive care intervention visit.

Time frame: Up to 2 years

perceived effectiveness

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.

Time frame: 3 months (+/- 3 weeks) from patient enrollment

Secondary Outcomes

change in patient quality of life

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.

Time frame: baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment

patient healthcare utilization

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.

Time frame: up to 2 years

patient quality of life

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.

Time frame: 3 months (+/- 3 weeks) from patient enrollment

Supportive Care Intervention-Pancreas

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes