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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04632303




Registration number
NCT04632303
Ethics application status
Date submitted
13/11/2020
Date registered
17/11/2020
Date last updated
1/10/2024

Titles & IDs
Public title
Early Palliative Care for Patients with Advanced Pancreatic Cancer.
Scientific title
Early Palliative Care for Patients with Advanced Pancreatic Cancer (EarlyCarePan).
Secondary ID [1] 0 0
GI 2031
Universal Trial Number (UTN)
Trial acronym
EarlyCarePan
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pancreatic Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Pancreatic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Early Palliative Care

Experimental: Early Palliative Care - 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.

No intervention: Standard Care Arm - Palliative care visit only upon request from attending oncologist(s) or patient/family.


Other interventions: Early Palliative Care
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
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adjusted mean change in global health status/QoL score at 12 weeks
Timepoint [1] 0 0
12 weeks
Secondary outcome [1] 0 0
Overall survival
Timepoint [1] 0 0
1 year
Secondary outcome [2] 0 0
Adjusted mean change from baseline in global health status/QoL at 6 and 24 weeks.
Timepoint [2] 0 0
24 weeks
Secondary outcome [3] 0 0
Adjusted mean change from baseline in functional and symptom scales at 6, 12 and 24 weeks
Timepoint [3] 0 0
24 weeks
Secondary outcome [4] 0 0
Chemotherapy dose intensity.
Timepoint [4] 0 0
24 weeks

Eligibility
Key inclusion criteria
* 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/06/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
7/10/2024
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Denmark
State/province [1] 0 0
Herlev

Funding & Sponsors
Primary sponsor type
Other
Name
Inna Chen, MD
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Bispebjerg Hospital
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Rigshospitalet, Denmark
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Hvidovre University Hospital
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Odense University Hospital
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Aalborg University Hospital
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Aarhus University Hospital
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
Vejle Hospital
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
Zealand University Hospital
Address [8] 0 0
Country [8] 0 0
Other collaborator category [9] 0 0
Other
Name [9] 0 0
Hillerod Hospital, Denmark
Address [9] 0 0
Country [9] 0 0
Other collaborator category [10] 0 0
Other
Name [10] 0 0
Herning Hospital
Address [10] 0 0
Country [10] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT04632303
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Mette Nissen, MD
Address 0 0
Herlev & Gentofte Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04632303