Supportive Care Intervention-Pancreas
SCI-P
A Pilot Trial of an Embedded Collaborative Model of Supportive Care for Pancreatic Cancer
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 7, 2013
CompletedFirst Posted
Study publicly available on registry
June 25, 2013
CompletedStudy Start
First participant enrolled
July 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedMay 12, 2016
May 1, 2016
2.1 years
June 7, 2013
May 10, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (3)
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
Other Outcomes (19)
patient illness understanding and care preferences
3 months (+/- 3 weeks) from patient enrollment
change in patient anxiety symptoms
baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
change in patient distress
baseline (time of enrollment) to 3 months (+/- 3 weeks) after enrollment
- +16 more other outcomes
Study Arms (2)
Supportive Care Intervention
EXPERIMENTALMonthly (minimum) patient \& caregiver visits with a Supportive Care physician, embedded within their standard oncological care (through collaboration with oncology providers).
Usual Care
NO INTERVENTIONParticipants will receive standard oncology care from their oncology providers.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Pittsburgh Cancer Institute (UPCI), Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yael Schenker, MD, MAS
University of Pittsburgh
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Medicine
Study Record Dates
First Submitted
June 7, 2013
First Posted
June 25, 2013
Study Start
July 1, 2013
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
May 12, 2016
Record last verified: 2016-05