Early recognition and optimal treatment of delirium in patients with advanced cancer

Delirium is a disorder of consciousness, attention and cognition and, as such,
a neuropsychiatric
complication that occurs frequently in patients with advanced cancer. Delirium
has a negative influence
on quality of life and on the ability for communication in a crucial phase of
illness for patients and their
families. Variable presentation of symptoms hinders recognition of delirium
significantly and therefore
patients are often being undertreated. Based on limited evidence the preferred
drug to treat delirium is
haloperidol. Improvement of recognition and treatment options for delirium are
warranted.

In this study, we aim to improve recognition of delirium in a palliative care
population with advanced
cancer and we aim to provide evidence for optimal treatment of delirium through
adequate dosing of
preferred neuroleptic.
Primary objectives:
1) To validate the Delirium Observation Screening Scale in patients with
advanced cancer.
2) To compare the efficacy of olanzapine treatment with haloperidol treatment
(standard care) in a randomised clinical trial with regard to reversibility and
time to recovery.

Secondary objective:
1) To determine delirium recall and delirium-related distress in patients with
advanced cancer and their primary caregivers.

To address the aforementioned objectives we designed a randomised clinical
trial for patients with advanced cancer who are admitted to the medical
oncology ward or hospice.

On admission to the medical oncology ward or hospice, all patients with
advanced cancer will be asked to participate in this study. Consenting patients
will be submitted to delirium observation screening according to Delirium
Observation Screening scale (DOS). Subsequently DOS screening will be performed
twice weekly until discharge. Each patient who*s score is > 3 (DOS positive)
is showing significant symptoms of delirium and will be submitted to the
revised Delirium Rating Scale (DRS-R-98) to confirm diagnosis. To test validity
of the DOS scale for this particular population, each DOS positive score will
be randomly matched with a patient with a DOS score < 3 (DOS negative) and this
patient will also be submitted to DRS-R-98. When diagnosis of delirium is
confirmed by DRS-98, patients will be randomised between treatment of delirium
with olanzapine or haloperidol (usual care). Treatment in both groups will
consist of identification and management of underlying aetiologies of delirium
if possible and adding neuroleptic medication for symptom control. Patients who
recover from their delirium episode as well as their caregivers will be asked
to complete the Delirium Experience Questionnaire (DEQ) to assess recall of the
delirium experience and the degree of distress related to the delirium episode.

Considering the fact that both medications are accepted medications for
treatment of delirium participating patients will not run unforeseen risks
other than the known side effects associated with these medications.
The nature of the burden associated with participation will mostly be limited
to interventions that are part of usual care in diagnosing and treating of
delirium. The extent of additional burden consists of short 10 minute
interviews with an independent assessor on day 1,2,3,4,7 and 14. On recovery
of delirium the trial will end and the patient will be asked to fill out a 10
minute questionnaire on delirium recall.