Clinical trial NCT01885884: Supportive Care Intervention-Pancreas
Official title: A Pilot Trial of an Embedded Collaborative Model of Supportive Care for Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advanced Pancreatic Cancer
Keywords: Supportive Care
Palliative Care
Pancreatic Cancer
Embedded, coordinated model of supportive care within oncology care
Patient and Caregiver support
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2013-06-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: trial feasibility
timeFrame: up to 2 years
measure: acceptability of intervention participation
timeFrame: 3 months (+/- 3 weeks) from patient enrollment
measure: intervention fidelity
timeFrame: Up to 2 years
measure: perceived effectiveness
timeFrame: 3 months (+/- 3 weeks) from patient enrollment
Secondary outcomes:
measure: change in patient quality of life
timeFrame: baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
measure: patient healthcare utilization
timeFrame: up to 2 years
measure: patient quality of life
timeFrame: 3 months (+/- 3 weeks) from patient enrollment
Other outcomes:
measure: patient illness understanding and care preferences
timeFrame: 3 months (+/- 3 weeks) from patient enrollment
measure: change in patient anxiety symptoms
timeFrame: baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
measure: change in patient distress
timeFrame: baseline (time of enrollment) to 3 months (+/- 3 weeks) after enrollment
measure: change in patient depressive symptoms
timeFrame: baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
measure: change in caregiver distress
timeFrame: baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
measure: change in caregiver burden
timeFrame: baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
measure: caregiver grief
timeFrame: 1-3 months after death of enrolled patient
measure: change in caregiver anxiety symptoms
timeFrame: baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
measure: change in caregiver depressive symptoms
timeFrame: baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
measure: caregiver perceptions of circumstances surrounding death and preparedness for death
timeFrame: 1-3 months after death of enrolled patient
measure: quality of life of seriously ill patients
timeFrame: 3 months (+/- 3 weeks) after enrollment
measure: patient emotional acceptance of illness
timeFrame: 3 months (+/- 3 weeks) after enrollment
measure: patient anxiety
timeFrame: 3 months (+/- 3 weeks) after enrollment
measure: patient distress
timeFrame: 3 months (+/- 3 weeks) after enrollment
measure: patient depression
timeFrame: 3 months (+/- 3 weeks) after enrollment
measure: caregiver distress
timeFrame: 3 months (+/- 3 weeks) after enrollment
measure: caregiver burden
timeFrame: 3 months (+/- 3 weeks) after enrollment
measure: caregiver anxiety symptoms
timeFrame: 3 months (+/- 3 weeks) after enrollment
measure: caregiver depressive symptoms
timeFrame: 3 months (+/- 3 weeks) after enrollment
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Cancer Institute (UPCI), Hillman Cancer Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Yael Schenker, MD, MAS
role: PRINCIPAL_INVESTIGATOR
References: