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Supportive Care Intervention-Pancreas (SCI-P)

Primary Purpose

Advanced Pancreatic Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Embedded Supportive Care

About this trial

This is an interventional supportive care trial for Advanced Pancreatic Cancer focused on measuring Supportive Care, Palliative Care, Pancreatic Cancer, Embedded, coordinated model of supportive care within oncology care, Patient and Caregiver support

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

University of Pittsburgh Cancer Institute (UPCI), Hillman Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Supportive Care Intervention

Usual Care

Arm Description

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

Participants will receive standard oncology care from their oncology providers.

Outcomes

Primary Outcome Measures

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.

acceptability of intervention participation

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

intervention fidelity

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

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.

Secondary Outcome Measures

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.

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.

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.

Full Information

NCT ID

NCT01885884

First Posted

June 7, 2013

Last Updated

May 10, 2016

Sponsor

University of Pittsburgh

1. Study Identification

Unique Protocol Identification Number

NCT01885884

Brief Title

Supportive Care Intervention-Pancreas

Acronym

SCI-P

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Completed

Study Start Date

July 2013 (undefined)

Primary Completion Date

August 2015 (Actual)

Study Completion Date

August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Pittsburgh

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Advanced Pancreatic Cancer

Keywords

Supportive Care, Palliative Care, Pancreatic Cancer, Embedded, coordinated model of supportive care within oncology care, Patient and Caregiver support

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Supportive Care Intervention

Arm Type

Experimental

Arm Description

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

Arm Title

Usual Care

Arm Type

No Intervention

Arm Description

Participants will receive standard oncology care from their oncology providers.

Intervention Type

Behavioral

Intervention Name(s)

Embedded Supportive Care

Primary Outcome Measure Information:

Title

trial feasibility

Description

Time Frame

up to 2 years

Title

acceptability of intervention participation

Description

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

Time Frame

3 months (+/- 3 weeks) from patient enrollment

Title

intervention fidelity

Description

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

Title

perceived effectiveness

Description

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 Outcome Measure Information:

Title

change in patient quality of life

Description

Time Frame

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

Title

patient healthcare utilization

Description

Time Frame

up to 2 years

Title

patient quality of life

Description

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

Other Pre-specified Outcome Measures:

Title

patient illness understanding and care preferences

Description

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.

Time Frame

3 months (+/- 3 weeks) from patient enrollment

Title

change in patient anxiety symptoms

Description

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.

Time Frame

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

Title

change in patient distress

Description

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.

Time Frame

baseline (time of enrollment) to 3 months (+/- 3 weeks) after enrollment

Title

change in patient depressive symptoms

Description

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.

Time Frame

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

Title

change in caregiver distress

Description

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.

Time Frame

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

Title

change in caregiver burden

Description

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.

Time Frame

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

Title

caregiver grief

Description

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.

Time Frame

1-3 months after death of enrolled patient

Title

change in caregiver anxiety symptoms

Description

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.

Time Frame

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

Title

change in caregiver depressive symptoms

Description

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.

Time Frame

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

Title

caregiver perceptions of circumstances surrounding death and preparedness for death

Description

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.

Time Frame

1-3 months after death of enrolled patient

Title

quality of life of seriously ill patients

Description

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.

Time Frame