Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04290364 |
| Other study ID # |
PanEffort-1 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 21, 2019 |
| Est. completion date |
September 1, 2023 |
Study information
| Verified date |
February 2024 |
| Source |
Nordsjaellands Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
For outcomes where unbiased historical control data are not available a prospective
observational approach is used. These include symptom burden, psychological health and
satisfaction with care.
The study will include 40-50 patients and their carers from September 2019 to September 2020.
Amendment 19th Nov. 2020: The number of patients and carers included increased to 70-75 to
allow for subgroup analyses.
Recruitment and informed consent
Recruitment to this project will take place in Dept. of Surgery, Hospital of North Zealand to
which all patients suspected of having pancreatic cancer and living in the northern catchment
area of the Capital Region of Copenhagen will be referred for further investigations. The
patients will be informed about their diagnosis by the responsible surgeon in the outpatient
clinic in an undisturbed environment. The patients will then be informed about the
possibility of participation in the present study. They will receive both oral and written
information about the project and will be allowed enough time to consider participation
before deciding, as long as it allows contact to the palliative care team within three weeks
from diagnosis. It is expected that most patients will come to Dept. of Surgery with a family
member or friend, as they are aware that they will receive the results from the
investigations performed. However, patients will be informed that they have a right to come
back for further information about the protocol accompanied by a family member or any other
person they want to bring. They will meet either a surgeon or a palliative care physician who
can give further information and answer any possible questions at this meeting.
Written informed consent will be obtained before any protocol related procedures are
performed.
Carers will receive separate oral and written information either on the same day as the
patient or when meeting the palliative care team on the first visit. Carers will sign a
separate consent form if they want to participate in the study. Carers have the same rights
as the patients regarding time for consideration and further information before signing the
consent form.
Palliative Care Intervention
Patients and carers will be seen on home-visits. The first time they will meet a doctor and
usually also a nurse, while follow-up home-visits can be undertaken by either a doctor or a
nurse. Home-visits are scheduled every four weeks. Patients can contact a doctor or a
specialised nurse on weekdays for consultation. The palliative care nurse will contact a
palliative care physician if needed for change of treatment or other reasons. Palliative care
is offered in parallel with any specific cancer treatment given.
The patients will receive standard palliative care including treatment of symptoms (e.g.
pain, nausea, weight loss, loss of appetite, diarrhoea or fatigue), psychosocial support,
physiotherapy, nutritional counselling and advance care planning, depending on their needs.
The palliative care team comprises physicians, nurses, a physiotherapist and a chaplain.
Patients and/or carers scoring 8 or more on HADS for anxiety and/or depression will be
advised to be referred to a psychologist via their general practitioner.
Change from standard of care
Patients with pancreatic cancer are normally referred to palliative care when the surgeon,
oncologist or general practitioner taking care of them find that they are not able to meet
their palliative care needs, or if the patients and their families request a referral. Most
patients are referred late in their trajectory and only half of the patients are referred. We
do not know whether patients not referred to palliative care in the routine setting have
palliative care needs, whether they are met by other physicians or whether they have unsolved
palliative care needs.
Patients accepting inclusion in the project will get specialised palliative care throughout
their trajectory, within three weeks after diagnosis until end-of-life or cure without
residual palliative care needs.
Both patients participating in the project and patients referred on-demand will receive
four-weekly visits in their homes. Patients participating in the project are guaranteed that
the first visit will take place within three weeks after diagnosis, whereas patients referred
on-demand might have to wait longer before they meet the palliative care team.
