It has been suggested that conducting clinical trials in palliative care is unethical and
may be burdensome for patients. Despite these suggestions, there is evidence that
the opinions of patients with advanced cancer are favourable towards clinical trials.
However this evidence is based on hypothetical studies; no studies have been done
which explore the opinions or experiences of patients who have actually participated
in symptom control trials. This thesis is the first study to examine the experiences of
advanced cancer patients who have participated in symptom control trials.
A qualitative study was conducted using a constructivist grounded theory approach.
Patients known to be in the palliative phase of their illness were purposively selected
from two double-blind placebo-controlled clinical trials of novel analgesic agents
that took place across two clinical centres in Scotland. Semi-structured interviews
were conducted until a suitable degree of data saturation was reached. In keeping
with a grounded theory approach, analysis of the generated data developed core
categories and a central theory that described the studied phenomenon.
Experiences of taking part in a clinical trial were initially divided into three parts:
pre-trial experiences, experiences during the trial and patients' reflections on the trial
after they had finished. Pre-trial experiences of the patients included the reasons for
taking part, their initial contact with the trial staff and their prior knowledge of
clinical trials. Experiences during the trial involved the manner in which they went
through the trial, the impact on their pain and the interaction with the trial staff.
Patients reflected on their overall opinion of the trial that they had taken part in and
clinical trials in general.
One of the most significant categories was the impact of the interaction with the
research staff. For some patients this relationship was beneficial, independent of the
pain response during the trial.
The central theory of the study related to a patient's wellbeing. All the different
aspects of participating in a clinical trial made an impact on a patient's sense of
wellbeing. Many different components of the trial, such as the relationship with the
trial staff, could have a positive impact on a patient's wellbeing. A positive impact
on wellbeing could be found even in the presence of something which may have a
negative impact on a patient's wellbeing, such as a lack of pain reduction.
This is the first study that explores the experiences of advanced cancer patients in
symptom control trials. I have described the factors that motivate patients to take
part in clinical trials, their experiences of being in the trials and how they view the
experience of the trial after it is finished. The results provide examples of
experiences that are very positive from a patient's perspective.
I have developed a concept of wellbeing that the clinical trial impacts upon. While a
patient's overall wellbeing is not exclusively linked to the clinical trial, the clinical
trial has the potential to have a large impact on the overall wellbeing of the patient.
Interventions such as the relationship with the trial staff can have a positive effect on
a patient's wellbeing, independent of the outcome of the trial from a pain
management point of view. The results of this study contribute to the debate on the
ethics and benefits of research in palliative care.