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

June 25, 2025 updated by: Fred Hutchinson Cancer Center

Preoperative, Specialty Palliative Care for Patients Considering Pancreatic Surgery: Pilot Feasibility and Acceptability Study

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutch/University of Washington Cancer Consortium

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm I (Usual care)
Patients receive usual care and undergo evaluation by a tumor board within 14 days of baseline.
Other: Best Practice
Receive usual care
Other Names:
  • standard of care
  • standard therapy
Other: Survey Administration
Ancillary studies
Other: Tumor Board Review
Undergo evaluation by tumor board
Other Names:
  • multidisciplinary opinion
Experimental: Arm II (Palliative care visit)
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.
Other: Survey Administration
Ancillary studies
Other: Tumor Board Review
Undergo evaluation by tumor board
Other Names:
  • multidisciplinary opinion
Procedure: Palliative Care Consultation
Attend a palliative care visit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of recruited patients that consent (acceptability)
Time Frame: At time of consent
Acceptability will be defined as ≥ 60% of recruited patients consented.
At time of consent
Percentage of patients randomized to the interventional arm who complete the palliative care consult prior to tumor board (feasibility)
Time Frame: 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.
At time of multidisciplinary tumor board discussion (No more than 14 days after baseline)

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of participants who complete the decisional conflict scale
Time Frame: At completion of 7 day follow-up timepoint
At completion of 7 day follow-up timepoint
Percentage of participants who complete study measures within the first 90 days
Time Frame: At completion of 90 day follow-up timepoint
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
Time Frame: At 90 day follow-up timepoint
At 90 day follow-up timepoint

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fred Hutchinson Cancer Center

Investigators

  • Principal Investigator: Elizabeth Loggers, Fred Hutch/University of Washington Cancer Consortium

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2025

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

July 22, 2024

First Submitted That Met QC Criteria

August 7, 2024

First Posted (Actual)

August 9, 2024

Study Record Updates

Last Update Posted (Actual)

June 29, 2025

Last Update Submitted That Met QC Criteria

June 25, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RG1124214
  • NCI-2024-05662 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • 20350 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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