Early Palliative Care for Patients With Pancreatic Cancer - Health Care Service Use and Quality of Life - a Quasi-experimental Study Using Historical Controls
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 74
- Locations
- 1
- Primary Endpoint
- Use of healthcare services
Study Overview
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.
Detailed Description
Study design
All patients with symptoms compatible with pancreatic cancer living in the northern catchment area of the Capital Region of Copenhagen, Denmark, are referred to Dept. of Surgery, Hospital of North Zealand for further investigations. Cases diagnosed with pancreatic cancer are discussed at a regional Multi-Disciplinary-Team (MDT) conference and either referred for surgery or chemotherapy or receive best supportive care in Dept. of Surgery. The Palliative Care Unit at Hospital of North Zealand covers the same geographical area with 310,000 inhabitants.
Patients referred to Dept. of Surgery and diagnosed with pancreatic cancer are offered participation in this study. All participants will receive home-visits from the palliative care team every four weeks, starting within three weeks from diagnosis and until end-of-life or cure without residual palliative needs.
The study design chosen is a quasi-experimental design using historical control patients for the primary outcome: use of health care services (acute hospital admissions, days in hospital) and the secondary outcomes: survival and place of death. The historical control patients were diagnosed before the introduction of early palliative care. The outcomes are readily available from patient records and are expected to carry a very low risk of registration 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.
Demographic data will be collected for participants and historical controls to evaluate if any selection bias or other systematic differences exist between the groups.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults newly diagnosed with pancreatic cancer in Dept. of Surgery, Hospital of North Zealand, Denmark
- •Caregivers involved in care or practical help
Exclusion Criteria
- •Inability to take an active part in answering questionnaires
Outcomes
Primary Outcomes
Use of healthcare services
Time Frame: Until death or end of study, an average of 8 months
Number of acute hospital admissions and number of days in hospital
Secondary Outcomes
- Anxiety and/or depression(Four-weekly until death or end of study, an average of 8 months)
- Carer satisfaction with palliative care(Three-monthly. The last time is at a follow-up visit after the patient has died, or at end of study, an average of 10 months)
- Quality of life: EORTC QLQ-PAN26(Four-weekly until death or end of study, an average of 8 months)
- Preferred and actual place of death(Until death or end of study, an average of 8 months)
- 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)
- Change in weight(Four-weekly until death or end of study, an average of 8 months)
Investigators
Inge Høgh Dufva
Consultant
Nordsjaellands Hospital