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

NCT06545344 | Withdrawn

• 3 other identifiers: RG1124214NCI-2024-0566220350
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Neoplasm

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

Study Arms (2)

Arm I (Usual care)

ACTIVE COMPARATOR

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

Arm II (Palliative care visit)

EXPERIMENTAL

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

Interventions

Best Practice OTHER

Receive usual care

Also known as: standard of care, standard therapy

Arm I (Usual care)

Palliative Care Consultation PROCEDURE

Attend a palliative care visit

Arm II (Palliative care visit)

Survey Administration OTHER

Ancillary studies

Arm I (Usual care); Arm II (Palliative care visit)

Tumor Board Review OTHER

Undergo evaluation by tumor board

Also known as: multidisciplinary opinion

Arm I (Usual care); Arm II (Palliative care visit)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Practice Guidelines as Topic; Standard of Care

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care

Study Officials

• Elizabeth Loggers

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: August 9, 2024
• Study Start: September 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: June 29, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)