A Pilot Trial of an Embedded Collaborative Model of Supportive Care for Pancreatic Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Advanced Pancreatic Cancer
- Sponsor
- University of Pittsburgh
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- trial feasibility
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Yael Schenker, MD, MAS
Assistant Professor of Medicine
University of Pittsburgh
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
Outcomes
Primary Outcomes
trial feasibility
Time Frame: up to 2 years
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
Time Frame: 3 months (+/- 3 weeks) from patient enrollment
We will report the percentage of patients and caregivers who found the intervention acceptable.
intervention fidelity
Time Frame: Up to 2 years
We will use post-visit checklists to characterize the number and types of recommended topics covered during each supportive care intervention visit.
perceived effectiveness
Time Frame: 3 months (+/- 3 weeks) from patient enrollment
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 Outcomes
- change in patient quality of life(baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment)
- patient healthcare utilization(up to 2 years)
- patient quality of life(3 months (+/- 3 weeks) from patient enrollment)