Supportive Care Intervention-Pancreas (SCI-P)

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

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 Overview

• Status: Completed
• Conditions: Advanced Pancreatic Cancer
• Intervention / Treatment: Behavioral: Embedded Supportive Care

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • University of Pittsburgh Cancer Institute (UPCI), Hillman Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Supportive Care Intervention; 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
No Intervention: Usual Care; Participants will receive standard oncology care from their oncology providers.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient illness understanding and care preferences	We will assess range and distribution of patient illness understanding using validated questions about patients' perceptions of curability, life expectancy, acknowledgement of whether or not s/he has a terminal illness, and preferences for comfort-oriented vs life-prolonging treatment. Because this is a pilot trial, we will not conduct formal tests of efficacy.	3 months (+/- 3 weeks) from patient enrollment
change in patient anxiety symptoms	We will assess change in patient anxiety symptoms with the Hospital Anxiety and Depression Scale (HADS) administered at baseline and 3 months. HADS scores will be compiled to assess range and distribution. Because this is a pilot trial, we will not conduct formal tests of efficacy.	baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
change in patient distress	We will summarize range and distribution of change in patient distress responses from baseline to 3 months, collected with the National Comprehensive Cancer Network (NCCN) Distress Thermometer tool, where patients rate their distress on a visual guide from 0, 'no distress' to 10, 'extreme distress.' Scores will be compiled to assess range and distribution at 3-months. Because this is a pilot trial, we will not conduct formal tests of efficacy.	baseline (time of enrollment) to 3 months (+/- 3 weeks) after enrollment
change in patient depressive symptoms	We will assess change in patient depression from baseline to 3 months with the Hospital Anxiety and Depression Scale (HADS) and the Primary Care Evaluation of Mental Disorders: Patient Health Questionnaire (PRIME-MD PHQ-9). HADS and PHQ-9 depression scores will be compiled to assess range and distribution at baseline and 3 months. Because this is a pilot trial, we will not conduct formal tests of efficacy.	baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
change in caregiver distress	We will summarize range and distribution of change in caregiver distress responses from baseline to 3 months, collected with the National Comprehensive Cancer Network (NCCN) Distress Thermometer tool. Because this is a pilot trial, we will not conduct formal tests of efficacy.	baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
change in caregiver burden	We will summarize the range and distribution of the reported change in caregiving burden from baseline to 3 months, collected with the Zarit Burden Interview and Family Member Concerns scale. Because this is a pilot trial, we will not conduct formal tests of efficacy.	baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
caregiver grief	We will assess caregiver grief after the death of their loved one (enrolled patient), if the patient dies during study participation and up to 2-year follow up. We will use the Inventory of Complicated Grief to assess how much and how often caregivers are affected by the loss of their loved one and summarize the range and distribution of this data. Because this is a pilot study, we will not conduct formal tests of efficacy.	1-3 months after death of enrolled patient
change in caregiver anxiety symptoms	We will assess change in caregiver anxiety symptoms from baseline to 3 months with the Hospital Anxiety and Depression Scale (HADS). HADS scores will be compiled to assess range and distribution. Because this is a pilot trial, we will not conduct formal tests of efficacy.	baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
change in caregiver depressive symptoms	We will assess change in caregiver depressive symptoms from baseline to 3 months with the Hospital Anxiety and Depression Scale (HADS). HADS scores will be compiled to assess range and distribution. Because this is a pilot trial, we will not conduct formal tests of efficacy.	baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
caregiver perceptions of circumstances surrounding death and preparedness for death	We will assess caregiver perceptions of circumstances surrounding death and preparedness for death using four previously validated questions. We will summarize range and distribution of responses. Because this is a pilot trial, we will not conduct formal tests of efficacy.	1-3 months after death of enrolled patient
quality of life of seriously ill patients	We will summarize range and distribution of patient quality of life using the Quality of Life - Seriously Ill Patients (QUAL-E) score. Because this is a pilot trial, we will not conduct formal tests of efficacy.	3 months (+/- 3 weeks) after enrollment
patient emotional acceptance of illness	We will summarize range and distribution of patient emotional acceptance of illness using the PEACE Scale. Because this is a pilot trial, we will not conduct formal tests of efficacy.	3 months (+/- 3 weeks) after enrollment
patient anxiety	We will summarize range and distribution of patient anxiety using the Hospital Anxiety and Depression Scale (HADS). Because this is a pilot trial, we will not conduct formal tests of efficacy.	3 months (+/- 3 weeks) after enrollment
patient distress	We will summarize range and distribution in patient distress responses, collected with the National Comprehensive Cancer Network (NCCN) Distress Thermometer tool, where patients rate their distress on a visual guide from 0, 'no distress' to 10, 'extreme distress.' Because this is a pilot trial, we will not conduct formal tests of efficacy.	3 months (+/- 3 weeks) after enrollment
patient depression	We will assess patient depression from with the Hospital Anxiety and Depression Scale (HADS) and the Primary Care Evaluation of Mental Disorders: Patient Health Questionnaire (PRIME-MD PHQ-9). HADS and PHQ-9 depression scores will be compiled to assess range and distribution. Because this is a pilot trial, we will not conduct formal tests of efficacy.	3 months (+/- 3 weeks) after enrollment
caregiver distress	We will summarize range and distribution in caregiver distress responses, collected with the National Comprehensive Cancer Network (NCCN) Distress Thermometer tool. Because this is a pilot trial, we will not conduct formal tests of efficacy.	3 months (+/- 3 weeks) after enrollment
caregiver burden	We will summarize the range and distribution of the reported caregiving burden, collected with the Zarit Burden Interview and Family Member Concerns scale. Because this is a pilot trial, we will not conduct formal tests of efficacy.	3 months (+/- 3 weeks) after enrollment
caregiver anxiety symptoms	We will assess caregiver anxiety symptoms with the Hospital Anxiety and Depression Scale (HADS). HADS scores will be compiled to assess range and distribution. Because this is a pilot trial, we will not conduct formal tests of efficacy.	3 months (+/- 3 weeks) after enrollment
caregiver depressive symptoms	We will assess caregiver depressive symptoms with the Hospital Anxiety and Depression Scale (HADS). HADS scores will be compiled to assess range and distribution. Because this is a pilot trial, we will not conduct formal tests of efficacy.	3 months (+/- 3 weeks) after enrollment

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Investigators: Principal Investigator: Yael Schenker, MD, MAS, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: June 7, 2013
• First Submitted That Met QC Criteria: June 24, 2013
• First Posted (Estimate): June 25, 2013

Study Record Updates

• Last Update Posted (Estimate): May 12, 2016
• Last Update Submitted That Met QC Criteria: May 10, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Pancreatic Cancer; Palliative Care; Supportive Care; Embedded, coordinated model of supportive care within oncology care; Patient and Caregiver support
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: PRO13020507