Supportive Care Intervention-Pancreas

Advanced Pancreatic Cancer Clinical Trial

— SCI-P  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01885884
• Other study ID #: PRO13020507
• Status: Active, not recruiting
• Phase: N/A
• First received: June 7, 2013
• Last updated: October 31, 2014
• Start date: July 2013

Study information

• Verified date: October 2014
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Advanced Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Behavioral:
• Embedded Supportive Care

Locations

Country	Name	City	State
United States	University of Pittsburgh Cancer Institute (UPCI), Hillman Cancer Center	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	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	No
Other	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	No
Other	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	No
Other	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	No
Other	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	No
Other	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	No
Other	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	No
Other	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	No
Other	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	No
Other	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	No
Other	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	No
Other	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	No
Other	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	No
Other	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	No
Other	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	No
Other	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	No
Other	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	No
Other	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No