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

NCT04290364 | Completed

• 1 other identifier: PanEffort-1
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 1

Brief 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

Pancreatic Cancer

Keywords

Palliative care

Outcome Measures

Primary Outcomes (1)

• Use of healthcare services

  Number of acute hospital admissions and number of days in hospital

  Until death or end of study, an average of 8 months

Secondary Outcomes (7)

• Survival

  Until death or end of study, an average of 8 months

• Quality of life: EORTC QLQ-C15-PAL

  Four-weekly until death or end of study, an average of 8 months

• Quality of life: EORTC QLQ-PAN26

  Four-weekly until death or end of study, an average of 8 months

• Anxiety and/or depression

  Four-weekly until death or end of study, an average of 8 months

• Change in weight

  Four-weekly until death or end of study, an average of 8 months

Study Arms (2)

Prospective cohort

Patients newly diagnosed with pancreatic cancer included in the prospective part of the study

Other: Palliative care

Retrospective cohort

Patients diagnosed with pancreatic cancer before early palliative care was introduced (historical control patients)

Interventions

Palliative care OTHER

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

Prospective cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients newly diagnosed with pancreatic cancer in Dept. of Surgery, Hospital of North Zealand, Denmark

You may qualify if:

• Adults newly diagnosed with pancreatic cancer in Dept. of Surgery, Hospital of North Zealand, Denmark
• Caregivers involved in care or practical help

You may not qualify if:

• Inability to take an active part in answering questionnaires

Sponsors & Collaborators

• Inge Høgh Dufva: lead

Study Sites (1)

Nordsjaellands Hospital

Frederikssund, 3600, Denmark

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Inge H Dufva

  Consultant, Palliative Care Unit, Nordsjaellands Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: February 20, 2020
• First Posted: February 28, 2020
• Study Start: September 21, 2019
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: February 9, 2024

Record last verified: 2024-02

Locations

DK (1)