Pancreatic CancerEarlyCarePanNCT04632303
Early Palliative Care for Patients With Advanced Pancreatic Cancer.
A study testing Early Palliative Care in people with Pancreatic Cancer, run by Inna Chen, MD at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Early Palliative Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteDenmark
- Study dates
- 23 Jun 2021to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Palliative Care for Patients With Advanced Pancreatic Cancer (EarlyCarePan).
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.
Read the detailed description
Pancreatic adenocarcinoma is one of the deadliest cancers. Approximately half of the patients diagnosed with advanced pancreatic cancer die within 2 months from the diagnosis. Patients eligible for systemic treatment have a median survival of less than one year and often receive limited benefit from chemotherapy, usually with progression of disease after only a few months of treatment. Patients with pancreatic cancer experience marked physical suffering, psychological distress and resource-demanding care at the end-of-life. Complications such as pain, fatigue, malnutrition, cachexia, exocrine insufficiency and diagnosis itself lead to a poor quality of life and are associated with high rates of depression and anxiety.
These invalidating symptoms are best alleviated by attachment to specialized palliative care and by starting this support early in the course of the disease and not just in the terminal phase. Early implementation of specialized palliative care is not a standard of care in Denmark.
Thus, an urgent need exists to evaluate the early, integrated palliative care model in a comparative study and across multiple care settings to define quality of life and survival benefits for patients with pancreatic cancer in Denmark.
- Conditions
- Pancreatic Cancer
- Being tested
- Early Palliative Care
- Keywords
- Pancreatic cancer, Early palliative care, Specialized palliative care
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Early Palliative Care |
| Standard Care Arm | No intervention | Palliative care visit only upon request from attending oncologist(s) or patient/family. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (4)
Overall survival
Overall survival after randomization, defined as the time from randomization to death from any cause.
Measured: 1 year
Adjusted mean change from baseline in global health status/QoL at 6 and 24 weeks.
Adjusted mean change from baseline in global health status/QoL score from the EORTC QLQ-C30 questionnaire at 6 and 24 weeks.
Measured: 24 weeks
Adjusted mean change from baseline in functional and symptom scales at 6, 12 and 24 weeks
Adjusted mean change from baseline in functional and symptom scales from the EORTC QLQ-C30 questionnaire at 6, 12 and 24 weeks.
Measured: 24 weeks
Chemotherapy dose intensity.
Chemotherapy dose intensity.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start23 Jun 2021
- Primary completion7 Nov 2024
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- 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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inna Chen, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Bispebjerg Hospital, Copenhagen University Hospital, Rigshospitalet, Hvidovre University Hospital, Odense University Hospital, Aalborg University Hospital, Aarhus University Hospital, Vejle Hospital, Zealand University Hospital, Hillerod Hospital, Denmark, Herning Hospital
- Responsible party
- Sponsor-investigator, Inna Chen, MD, Herlev Hospital
- Investigators
- Mette Nissen, MD, Principal investigator, Herlev & Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04632303
- Sponsor's protocol ID
- GI 2031
- Acronym
- EarlyCarePan
- Status last verified
- Sep 2025
- First submitted
- 13 Nov 2020
- Last updated
- 12 Sep 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 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Palliative Care for Patients With Advanced Pancreatic Cancer (EarlyCarePan).
- ClinicalTrials.gov ID
- NCT04632303
- Acronym / sponsor ID
- EarlyCarePan / GI 2031
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatic cancer, Early palliative care, Specialized palliative care
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Inna Chen, MDUniversity, hospital or other
- Collaborators
- Bispebjerg Hospital, Copenhagen University Hospital, Rigshospitalet, Hvidovre University Hospital, Odense University Hospital, Aalborg University Hospital, Aarhus University Hospital, Vejle Hospital, Zealand University Hospital, Hillerod Hospital, Denmark, Herning Hospital
- Study start
- 23 Jun 2021 (actual)
- Primary completion
- 7 Nov 2024 (actual)
- Study completion
- Nov 2026 (estimated)
- First posted
- 17 Nov 2020 (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.
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.
Detailed description
Pancreatic adenocarcinoma is one of the deadliest cancers. Approximately half of the patients diagnosed with advanced pancreatic cancer die within 2 months from the diagnosis. Patients eligible for systemic treatment have a median survival of less than one year and often receive limited benefit from chemotherapy, usually with progression of disease after only a few months of treatment. Patients with pancreatic cancer experience marked physical suffering, psychological distress and resource-demanding care at the end-of-life. Complications such as pain, fatigue, malnutrition, cachexia, exocrine insufficiency and diagnosis itself lead to a poor quality of life and are associated with high rates of depression and anxiety.
These invalidating symptoms are best alleviated by attachment to specialized palliative care and by starting this support early in the course of the disease and not just in the terminal phase. Early implementation of specialized palliative care is not a standard of care in Denmark.
Thus, an urgent need exists to evaluate the early, integrated palliative care model in a comparative study and across multiple care settings to define quality of life and survival benefits for patients with pancreatic cancer in Denmark.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Palliative Care | Experimental | Other: Early Palliative CareBaseline 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. |
| Standard Care Arm | No intervention | –Palliative care visit only upon request from attending oncologist(s) or patient/family. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Early Palliative CareBaseline 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 | Other | Early Palliative Care |
Primary outcome
Adjusted mean change in global health status/QoL score at 12 weeks
Time frame: 12 weeks
Adjusted mean change from baseline in global health status/QoL score from the EORTC QLQ-C30 questionnaire at 12 weeks.
4 secondary outcomes
Overall survival
Time frame: 1 year
Adjusted mean change from baseline in global health status/QoL at 6 and 24 weeks.
Time frame: 24 weeks
Adjusted mean change from baseline in functional and symptom scales at 6, 12 and 24 weeks
Time frame: 24 weeks
Chemotherapy dose intensity.
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 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.
Mette Nissen, MD principal investigator
Herlev & Gentofte Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Palliative Care in people with Pancreatic Cancer, run by Inna Chen, MD at 1 site in Denmark.
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 6 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: under way, not looking for participants, as of the sponsor's last update on 12 Sep 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 Denmark. 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?
This study is still under way. Results are not available in the source record yet.
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?
Adjusted mean change in global health status/QoL score at 12 weeks (time frame: 12 weeks). 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 12 Sep 2025.