Download Stephanie Sivell Qualfrag Gregynog

Using qualitative methodology to explore
palliative lung cancer patients’ experiences
of participating in a clinical trial
Stephanie Sivell, Simon Noble, Emily Harrop, Michelle Edwards,
Kerry Hood, Gareth Griffiths, Anthony Byrne, Barbara Moore,
Annmarie Nelson
Background
• Under-representation of palliative care lung cancer in
clinical trials
• Little is understood about experiences of participating in
clinical trials and impact on quality of life
• Qualitative sub-study of lung cancer clinical trial
(FRAGMATIC)
– Largest lung cancer study in the UK
• 81 centres
• Over 2000 patients recruited to date
– A randomised phase lll clinical trial
– Effect of FRAGMin® added to standard therapy
FRAGMATIC
Trial Design
Patients with histopathologically or cytologically
confirmed primary lung cancer of any stage or
histology
Consent and randomisation within 7 weeks of tissue
diagnosis (pathological report date) and before the
start of treatment
Randomise
Control Arm
Intervention Arm
Anticancer treatment
(local practice)
Anticancer treatment
(local practice)
and
START DALTEPARIN
before first definitive
anticancer treatment
(1 x daily dalteparin 5,000 IU
subcutaneous for 24 weeks)
(NO DALTEPARIN)
Follow-Up
Every 3-4 weeks from randomisation
(until week 24 visit)
Then at 9 months, 1 year and at routine follow-up
appointments thereafter
FRAGMATIC
Outcomes
Primary Outcome
Overall survival
Secondary Outcomes
Venous thrombotic event free survival
Serious Adverse Events
Metastasis-free survival
Toxicity
Quality of life
Breathlessness
Anxiety and depression
Cost effectiveness
Cost utility
Aims
• To explore:
– Prioritisation and management of symptom burden over time
– Psychological impact of participation in with particular emphasis on
equipoise
– Acceptability of long-term heparin as a therapy in advanced lung
cancer
– Impact of clinical trial monitoring processes and implications for
service modelling
Methods
•
•
•
•
Semi-structured interviews
12-20 patients (6-10 patients per arm)
3 interviews at weeks 1, 6 and 24
5 recruiting centres:
Velindre; Llandough Hospital (Cardiff); Royal Gwent (Newport);
Neville Hall hospital (Abergavenny); Bristol Haematology
• Interpretative Phenomenological Analysis (IPA)
– Identify emergent themes that reflect participants’
lived experiences
Participants
No. Eligible
No.
Approached
No.
Consented
to Interview
10
9
5
No.
Interviews
held*
3
(+ 2 arranged)
*Wave 1 interviews
• Three interviewees:
– 1 from the Intervention arm (70 years of age)
– 2 from the Control arm (75 and 59 years of age)
Preliminary Results
• Motivations for participation
• Understanding of trial information
–
–
–
outcomes and purpose of trial
process of randomisation
engagement with information
• Symptom management and burden
• Acceptability of treatment
Preliminary Results:
Motivations for Participation
P1 (Intervention)
• Motivations to participate
primarily for own benefit (benefit
of future cancer patients of
secondary importance)
“It was me first...you know I’m all for humanity
but it starts with me.”
P2 (Control)
• Altruistic motives
“It’s for the benefit of others and that’s where
we should be looking”
• Acceptance of being on the
“wrong side”
“whatever they decided would be the benefit
was, that was more essential. It’s not what I
felt, it’s what would give the best results and if
it was felt that I ought to be on one side or the
other I’ll go along with that.”
Preliminary Results:
Understanding of Trial Information
P1 (Intervention)
P2 (Control)
• Did not want in-depth information
“Though we’ve had a certain amount just basic
(information), you know, what’s it’s for or what
they are hoping to achieve.. Um but with
regards to anything in depth well I don’t really
want to know”
• ‘Chosen’ to receive treatment
• Information overload and
selective hearing
“Well I hear things that I want to hear and
very often don’t hear things I don’t want to
hear.”
• Misunderstood purpose of trial
“Well, it’s someone who doesn’t know you doing
it…….So it’s not favouritism…um, they make a “…is to see if they can stop 2 things
happening. One is blood clots, …and the
decision on the facts that they are given and
other one where they get the treatment
that’s it”
through to the cancer …at a better rate”
• Misunderstood purpose of trial
“…it could help shrink the cancers as
well……That’s what they are hoping for”
Preliminary Results:
Symptom Management and Burden
P1 (Intervention)
• Bruising the only physical side effect
“Everyday. I’m black and blue, I am.”
• Copes with the side effects (bruising) by focusing on the perceived
benefits (preventing blood clots and shrinking cancer)
Preliminary Results:
Acceptability of Treatment
P1 (Intervention)
• Readily accepted having daily injections
• Does not like having, nor like watching others have, injections
“Because normally even on television you see a medical programme and
you see them injecting (laughs) I look away…….Yeah and then I got to do it
myself. It’s for a purpose”
• Overcome dislike and copes with side effects by focusing on
perceived benefits (preventing blood clots and shrinking cancer)
• Can feel the sensation of the injection going in, but...
“I can feel it going in but uh…..You know, it’s done and that’s it. It’s a
minute at the most, if that and then it’s gone”
• Built up a routine of having injection every morning – wife sometimes
helps
‘Conclusions’
• Patients do not always fully understand the process of
randomisation or purpose of trial
• Ethical issues to consider:
– Truly giving informed consent?
– Impact of non-placebo trial on patients’ hope and coping.
– Influence of understanding of trial on acceptability of treatment and
its side effects