Clinical trial NCT06545344: Palliative Care Consultation to Improve Communication for Patients Considering Surgery for a Pancreatic Neoplasm
Official title: Preoperative, Specialty Palliative Care for Patients Considering Pancreatic Surgery: Pilot Feasibility and Acceptability Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pancreatic Neoplasm
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of recruited patients that consent (acceptability)
timeFrame: At time of consent
measure: Percentage of patients randomized to the interventional arm who complete the palliative care consult prior to tumor board (feasibility)
timeFrame: At time of multidisciplinary tumor board discussion (No more than 14 days after baseline)
Secondary outcomes:
measure: Percentage of participants who complete the decisional conflict scale
timeFrame: At completion of 7 day follow-up timepoint
measure: Percentage of participants who complete study measures within the first 90 days
timeFrame: At completion of 90 day follow-up timepoint
measure: Percentage of participants randomized to usual care who go on to receive palliative care within the active study period
timeFrame: At 90 day follow-up timepoint
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Elizabeth Loggers
role: PRINCIPAL_INVESTIGATOR
References: