2025-05-01
2026-01-01
2026-01-01
40
NCT06545344
Fred Hutchinson Cancer Center
Fred Hutchinson Cancer Center
INTERVENTIONAL
Palliative Care Consultation to Improve Communication for Patients Considering Surgery for a Pancreatic Neoplasm
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.
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.
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 Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2024-07-22 | N/A | 2025-03-06 |
2024-08-07 | N/A | 2025-03-07 |
2024-08-09 | N/A | 2024-12 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Supportive Care
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
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
OTHER: Survey Administration
OTHER: Tumor Board Review
|
| 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. | PROCEDURE: Palliative Care Consultation
OTHER: Survey Administration
OTHER: Tumor Board Review
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Percentage of recruited patients that consent (acceptability) | 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) | 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 | Measure Description | Time Frame |
|---|---|---|
| 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Elizabeth Loggers Phone Number: 206-667-7442 Email: eloggers@fredhutch.org |
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.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
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