A randomized trial in cancer-related fatigue in palliatively treated patients: protocolized patient-tailored treatment of physical symptoms (PPT) vs care as usual (CAU)

Fatigue is one of the most prevalent symptoms among advanced cancer patients in
the palliative phase and is most frequently reported to considerably influence
quality of life and daily functioning. The specfic mechanisms underlying
fatigue are not fully known, but several physical factors play a role.
Depending on the study populations and designs different independent predictors
of fatigue have been reported in the literature. These include physical
symptoms, anxiety, depression, cancer treatment, stage of disease and primary
cancer site. In a previously study performed at the Palliative Care Unit of the
Erasmus MC, physical symptoms were found to be associated with the different
dimensions of fatigue.
Since the underlying pathogenesis of fatigue remains relatively unknown to this
date, cancer-related fatigue is difficult to treat. The existing (non-)
pharmacological interventions are only succesful or even possible under limited
circumstances. Although several physical symptoms are found to be significantly
associated with fatigue, to this date no studies have been conducted on the
effect of treatment of symptoms on fatigue.

The objective of this study is to determine the effectiveness of receiving a
multidisciplinary protocolized patient-tailored treatment of physical symptoms
(PPT) in combination with structurally monitoring of reported symptoms (the
intervention) on multidimensional fatigue, quality of life and daily
interference.

This is a single-centre, randomized intervention-phase III study in palliative
cancer patients with solid tumours. Patients will be randomly allocated in a
1:1 ratio between two study arms (intervention or treatment as usual). The
planned study duration per patient is three months. The planned duration of the
entire period is approximately three years.

Patients randomized in the intervention-arm of the study will participate for 3
months in a complex intervention. The intervention will be conducted by a
trained nurse specialist. This nurse specialist is responsible for the
monitoring and exploration of the experienced physical symptoms,
patient-tailored education and she is responsible for the communication with
the physician.
During the intervention the patient will have at least three face-to-face
contacts with the nurse specialist (baseline, 2 and 6 weeks). Also one
telephone contact will take place, 9 weeks after baseline. The intervention
consist of two parts: receiving multidisciplinary protocolized treatment for
one or more symptoms and structurally monitoring these symptoms in a diary.
Treatment protocols are available for the following seven symptoms: pain,
dyspnoea, constipation, nausea/vomiting, dry mouth, cough and lack of appetite.

There are no risks associated with participation of this study.