Pancreatic NeoplasmNCT06545344
Palliative Care Consultation to Improve Communication for Patients Considering Surgery for a Pancreatic Neoplasm
A study testing Best Practice, Palliative Care Consultation and Survey Administration in people with Pancreatic Neoplasm, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Neoplasm
- What is being tested?
- Best Practice, Palliative Care Consultation and Survey Administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2025to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: 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.
Read the 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.
- Conditions
- Pancreatic Neoplasm
- Being tested
- Best Practice, Palliative Care Consultation, Survey Administration, Tumor Board Review
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive usual care
Palliative Care ConsultationProcedure or surgery
Attend a palliative care visit
Survey AdministrationOther
Ancillary studies
Tumor Board ReviewOther
Also called multidisciplinary opinion
Undergo evaluation by tumor board
| Study group | Role | What they receive |
|---|---|---|
| Arm I (Usual care) | Active comparator | Patients receive usual care and undergo evaluation by a tumor board within 14 days of baseline. Receives: 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. Receives: Procedure: Palliative Care Consultation; Other: Survey Administration; Other: Tumor Board Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of recruited patients that consent (acceptability)
Acceptability will be defined as ≥ 60% of recruited patients consented.
Measured: 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.
Measured: 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
Measured: At completion of 7 day follow-up timepoint
Percentage of participants who complete study measures within the first 90 days
Measured: 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
Measured: At 90 day follow-up timepoint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start1 Sep 2025 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2026 (estimated)
Why it stopped: Study closed before opening to accrual; Insufficient staff
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic NeoplasmStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth Loggers, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06545344
- Sponsor's protocol ID
- RG1124214
- Other IDs
- NCI-2024-05662, 20350
- Status last verified
- Dec 2024
- First submitted
- 22 Jul 2024
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative, Specialty Palliative Care for Patients Considering Pancreatic Surgery: Pilot Feasibility and Acceptability Study
- ClinicalTrials.gov ID
- NCT06545344
- Acronym / sponsor ID
- RG1124214
- Conditions
- Pancreatic Neoplasm
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study closed before opening to accrual; Insufficient staff
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (Usual care) | Active comparator | Other: Best Practice, Other: Survey Administration, Other: Tumor Board ReviewPatients receive usual care and undergo evaluation by a tumor board within 14 days of baseline. |
| Arm II (Palliative care visit) | Experimental | Procedure: Palliative Care Consultation, Other: Survey Administration, Other: Tumor Board ReviewPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyReceive usual care | Other | Arm I (Usual care) |
| Palliative Care ConsultationAttend a palliative care visit | Procedure or surgery | Arm II (Palliative care visit) |
| Survey AdministrationAncillary studies | Other | Arm I (Usual care), Arm II (Palliative care visit) |
| Tumor Board ReviewAlso: multidisciplinary opinionUndergo evaluation by tumor board | Other | Arm I (Usual care), Arm II (Palliative care visit) |
Primary outcome
Percentage of recruited patients that consent (acceptability)
Time frame: 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)
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.
3 secondary outcomes
Percentage of participants who complete the decisional conflict scale
Time frame: 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
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Loggers principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice, Palliative Care Consultation and Survey Administration in people with Pancreatic Neoplasm, run by Fred Hutchinson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of recruited patients that consent (acceptability) (time frame: At time of consent). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2025.