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Early Palliative Care in Pancreatic Cancer - a Quasi-experimental Study

NCT04290364 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 74

Last updated 2024-02-09

No results posted yet for this study

Summary

The aim of the proposed study is to understand the palliative care needs of patients with pancreatic cancer, to investigate whether early palliative care can improve patient outcomes and reduce use of health care services, and to understand the psychological health of carers and their satisfaction with care.

A quasi-experimental design is used, introducing palliative care for patients with pancreatic cancer within three weeks from diagnosis. The patients are recruited in Dept. of Surgery, Hospital of North Zealand, which covers the northern catchment area of the Capital Region of Copenhagen, Denmark. Patients are seen by the palliative care team on home-visits every four weeks throughout their trajectory, and quality of life is evaluated using the following quality of life questionnaires (QLQs): European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer Patients receiving palliative care (EORTC QLQ-C15-PAL), European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Pancreatic Cancer Patients (EORTC QLQ-PAN26), and Hospital Anxiety and Depression Scale (HADS). For carers, mental health is evaluated using HADS and satisfaction with care is evaluated using the Family Caregivers' Satisfaction With Palliative Care in Advanced Cancer Questionnaire (FAMCARE-2).

The primary outcome is health care service use (acute hospital admissions, days in hospital). Secondary outcomes are survival and place of death. Data are compared with historical control patients treated in the same hospital before introduction of early palliative care. These outcomes are readily available from patient records and are expected to carry a very low risk of bias.

Palliative care needs at referral in the study group will be compared with palliative care needs in the subgroup of historical control patients referred to palliative care on-demand.

For outcomes where unbiased historical control data are not available a prospective observational approach is used. These include symptom burden, weight, psychological health and satisfaction with care.

The minimum sample size needed to show a clinically significant decrease in acute hospital admissions is 70, 35 participating in the prospective study and 35 historical control patients. The study will include 40-50 patients and their carers from September 2019 to September 2020.

Conditions

Interventions

OTHER

Palliative care

The patients in the prospective part of the study are seen on home-visits and offered standard palliative care within three weeks of diagnosis.

Sponsors & Collaborators

  • Inge Høgh Dufva

    lead OTHER

Principal Investigators

  • Inge H Dufva · Consultant, Palliative Care Unit, Nordsjaellands Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-21
Primary Completion
2023-09-01
Completion
2023-09-01

Countries

  • Denmark

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04290364 on ClinicalTrials.gov