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 Consent and randomisation within 7 weeks of tissue diagnosis (pathological report date) and before the start of treatment Control Arm Anticancer treatment (local practice) (NO DALTEPARIN) Intervention Arm and START DALTEPARIN before first definitive anticancer treatment (1 x daily dalteparin 5,000 IU subcutaneous for 24 weeks) 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 Patients with histopathologically or cytologically confirmed primary lung cancer of any stage or histology Randomise FRAGMATIC Trial Design

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

No. Consented to Interview Participants No. Eligible No. Approached No. Consented to Interview No. Interviews held* 10 9 5 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) P2 (Control) 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.” 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 “Well, it’s someone who doesn’t know you doing it…….So it’s not favouritism…um, they make a decision on the facts that they are given and that’s it” Misunderstood purpose of trial “…it could help shrink the cancers as well……That’s what they are hoping for” 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 “…is to see if they can stop 2 things happening. One is blood clots, …and the other one where they get the treatment through to the cancer …at a better rate”

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