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Early Palliative Care for Patients With Advanced Pancreatic Cancer. (EarlyCarePan)

Primary Purpose

Pancreatic Cancer

Status

Recruiting

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Early Palliative Care

About this trial

This is an interventional supportive care trial for Pancreatic Cancer focused on measuring Pancreatic cancer, Early palliative care, Specialized palliative care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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.

Sites / Locations

Herlev & Gentofte University Hospital, DenmarkRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Early Palliative Care

Standard Care Arm

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall survival

Overall survival after randomization, defined as the time from randomization to death from any cause.

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.

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.

Chemotherapy dose intensity.

Full Information

NCT ID

NCT04632303

First Posted

November 13, 2020

Last Updated

February 28, 2023

Sponsor

Inna Chen, MD

Collaborators

Bispebjerg Hospital, Rigshospitalet, Denmark, Hvidovre University Hospital, Odense University Hospital, Aalborg University Hospital, Aarhus University Hospital, Vejle Hospital, Zealand University Hospital, Hillerod Hospital, Denmark, Herning Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04632303

Brief Title

Early Palliative Care for Patients With Advanced Pancreatic Cancer.

Acronym

EarlyCarePan

Official Title

Early Palliative Care for Patients With Advanced Pancreatic Cancer (EarlyCarePan).

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 23, 2021 (Actual)

Primary Completion Date

January 1, 2024 (Anticipated)

Study Completion Date

July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Inna Chen, MD

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer

Keywords

Pancreatic cancer, Early palliative care, Specialized palliative care

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Early Palliative Care

Arm Type

Experimental

Arm Description

Arm Title

Standard Care Arm

Arm Type

No Intervention

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Early Palliative Care

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Overall survival

Description

Overall survival after randomization, defined as the time from randomization to death from any cause.

Time Frame

1 year

Title

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

Description

Adjusted mean change from baseline in global health status/QoL score from the EORTC QLQ-C30 questionnaire at 6 and 24 weeks.

Time Frame

24 weeks

Title

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

Description

Adjusted mean change from baseline in functional and symptom scales from the EORTC QLQ-C30 questionnaire at 6, 12 and 24 weeks.

Time Frame

24 weeks

Title

Chemotherapy dose intensity.

Description

Chemotherapy dose intensity.

Time Frame

24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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. 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mette Nissen, MD

Phone

+45 38686167

mette.nissen.01@regionh.dk

First Name & Middle Initial & Last Name or Official Title & Degree

Inna M Chen, MD

Phone

+45 38682898

Inna.Chen@regionh.dk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mette Nissen, MD

Organizational Affiliation

Herlev & Gentofte Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Herlev & Gentofte University Hospital, Denmark

City

Herlev

ZIP/Postal Code

2730

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mette Nissen, MD

Phone

+45 38686167

mette.nissen.01@regionh.dk

First Name & Middle Initial & Last Name & Degree

Inna M Chen, MD

Phone

+45 38682898

Inna.Chen@regionh.dk

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Early Palliative Care for Patients With Advanced Pancreatic Cancer.

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