Supportive Care Intervention-Pancreas

Study Overview
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Brief Summary
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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.

Official Title
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A Pilot Trial of an Embedded Collaborative Model of Supportive Care for Pancreatic Cancer

Conditions
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Advanced Pancreatic Cancer

Intervention / Treatment
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* Behavioral: Embedded Supportive Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive Care Intervention<br>Monthly (minimum) patient & caregiver visits with a Supportive Care physician, embedded within their standard oncological care (through collaboration with oncology providers). | Behavioral: Embedded Supportive Care<br> <br> |
| No Intervention: Usual Care<br>Participants will receive standard oncology care from their oncology providers. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | up to 2 years | 
| acceptability of intervention participation | We will report the percentage of patients and caregivers who found the intervention acceptable. | 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. | 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. | 3 months (+/- 3 weeks) from patient enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 3 months (+/- 3 weeks) from patient enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Supportive Care, Palliative Care, Pancreatic Cancer, Embedded, coordinated model of supportive care within oncology care, Patient and Caregiver support