NCT04632303

Brief Summary

Pancreatic adenocarcinoma is one of the deadliest cancers. Patients with pancreatic cancer experience marked physical suffering, psychological distress and resource-demanding care at the end-of-life. Therefore, an urgent need exists to evaluate the early specialized palliative care model in a comparative study and across multiple care settings to define quality of life and survival benefits in patients with pancreatic cancer.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable pancreatic-cancer

Timeline
6mo left

Started Jun 2021

Longer than P75 for not_applicable pancreatic-cancer

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Jun 2021Nov 2026

First Submitted

Initial submission to the registry

November 13, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 17, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

June 23, 2021

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 7, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Expected
Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

3.4 years

First QC Date

November 13, 2020

Last Update Submit

September 8, 2025

Conditions

Pancreatic Cancer

Keywords

Pancreatic cancerEarly palliative careSpecialized palliative care

Outcome Measures

Primary Outcomes (1)

  • Adjusted mean change in global health status/QoL score at 12 weeks

    Adjusted mean change from baseline in global health status/QoL score from the EORTC QLQ-C30 questionnaire at 12 weeks.

    12 weeks

Secondary Outcomes (4)

  • Overall survival

    1 year

  • Adjusted mean change from baseline in global health status/QoL at 6 and 24 weeks.

    24 weeks

  • Adjusted mean change from baseline in functional and symptom scales at 6, 12 and 24 weeks

    24 weeks

  • Chemotherapy dose intensity.

    24 weeks

Study Arms (2)

Early Palliative Care

EXPERIMENTAL

Baseline palliative care visit within 10 calendar days of registration/randomization and palliative care visits (either at clinic or at home) or phone calls (if a visit is not feasible) at least every four weeks throughout the patient's life. Referral to exercise training and nutritional specialist.

Other: Early Palliative Care

Standard Care Arm

NO INTERVENTION

Palliative care visit only upon request from attending oncologist(s) or patient/family.

Interventions

Early Palliative CareOTHER

Baseline palliative care visit Palliative care visits/calls at least every 4 weeks throughout life and additionally upon request Referral to exercise training Referral to nutritional specialist

Early Palliative Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult males and females (aged 18 and over)
  • Confirmed by cytology or histology incurable PDAC who are planned to receive medical care for cancer in the first-line setting at the enrolling institution within ≤ 2 weeks
  • Written informed consent before any study procedures
  • Performance status: ECOG 0-2
  • Ability to read and respond to questions or able to complete questions with minimal assistance required from an interpreter or family member
  • Planning to receive all medical care for cancer at the enrolling institution.

You may not qualify if:

  • Patients who are already receiving care from the palliative care service are not eligible for participation in the study
  • Exhibiting signs of overt psychopathology or cognitive dysfunction
  • Any medical condition that the Investigator considers significant to compromise the safety of the patient or that impairs the interpretation of study assessments
  • Patient participating in another interventional study during the surveillance period. This is only relevant for studies that might interfere with the intervention. Participation in protocols related only to treatment will not preclude participation in the present study. Cases of doubt will be settled by the protocol responsible.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herlev & Gentofte University Hospital, Denmark

Herlev, 2730, Denmark

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Mette Nissen, MD

    Herlev & Gentofte Hospital

    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 INVESTIGATOR
PI Title
Senior physician

Study Record Dates

First Submitted

November 13, 2020

First Posted

November 17, 2020

Study Start

June 23, 2021

Primary Completion

November 7, 2024

Study Completion (Estimated)

November 1, 2026

Last Updated

September 12, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)