Palliative Care Consultation to Improve Communication for Patients Considering Surgery for a Pancreatic Neoplasm

Not Applicable

Withdrawn

• Conditions: Pancreatic Neoplasm

• Registration Number: NCT06545344
• Lead Sponsor: Fred Hutchinson Cancer Center

Brief Summary

This clinical trial evaluates a palliative care consultation for improving communication between providers and patients considering surgery for a pancreatic neoplasm. Pancreatic operations have known complications that can affect quality of life. Palliative care has been shown to improve patient reported quality of life and functional outcomes. Receiving a palliative care consultation may improve communication and decision making for patients considering surgery for a pancreatic neoplasm.

Detailed Description

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive usual care and undergo evaluation by a tumor board within 14 days of baseline.

ARM II: Patients attend a palliative care visit over 60 minutes to discuss their illness, quality of life, fears and concerns and communication preferences within 7 days of baseline. Patients also undergo evaluation by a tumor board within 14 days of baseline.

After completion of study intervention, patients are followed up 7 days after the tumor board visit and 90 days after initiation of treatment.

Study Timeline

• Study First Submitted: 2024-07-22
• Study First Submitted QC: 2024-08-07
• Study First Posted: 2024-08-09
• Status Verified: 2024-12
• Last Update Submitted: 2025-06-25
• Last Update Posted: 2025-06-29
• Study Start: 2025-09-01
• Primary Completion: 2026-01-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Adults (18 years or older)
• Pancreatic neoplasm pathology
• Ability to read, write, and speak in English
• Has decisional capacity
• Expected to be seen and discussed at PCSC and seeing a surgeon as part of their tumor board evaluation

Exclusion Criteria

• Metastatic pancreatic neoplasm
• Currently incarcerated
• Currently is or previously has received palliative care, or are unwilling to forego palliative care for the first 90 days post randomization
• Evidence of any behavior, condition, or circumstance (including, but not limited to: blindness, deafness, serious behavior or mental health conditions, discontinuing curative treatment, lack of access to technology, etc) that would interfere with their ability to complete study procedures as noted within the chart

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of recruited patients that consent (acceptability)	At time of consent	Acceptability will be defined as ≥ 60% of recruited patients consented.
Percentage of patients randomized to the interventional arm who complete the palliative care consult prior to tumor board (feasibility)	At time of multidisciplinary tumor board discussion (No more than 14 days after baseline)	Feasibility will be defined as ≥ 60% of patients randomized to interventional arm who complete palliative care consult prior to pancreatic cancer specialty clinic tumor board.

Secondary Outcome Measures

Name	Time	Method
Percentage of participants who complete the decisional conflict scale	At completion of 7 day follow-up timepoint
Percentage of participants who complete study measures within the first 90 days	At completion of 90 day follow-up timepoint
Percentage of participants randomized to usual care who go on to receive palliative care within the active study period	At 90 day follow-up timepoint

Trial Locations

Locations (1)

Fred Hutch/University of Washington Cancer Consortium; 🇺🇸 Seattle, Washington, United States