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Investigating the decision making process in patients with non-curative cancer who have been invited to join a clinical research trial. Student: Mary Murphy Supervision team: Prof Donna Fitzsimons Prof Eilis McCaughan Dr Richard Wilson

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Investigating the decision making process in patients with non-curative cancer who have been invited to join a clinical research trial

Student: Mary Murphy

Supervision team: Prof Donna Fitzsimons

Prof EilisMcCaughan

Dr Richard Wilson

This is an R & D HSC funded fellowship


Study aim
Study Aim non-curative cancer who have been invited to join a clinical research trial

To understand the decision making processes of patients with incurable cancer, within the context of clinical research trials.


Setting and data collection
Setting and Data Collection non-curative cancer who have been invited to join a clinical research trial

  • BHSCT Cancer Centre

  • Range from Phase I to Phase III

  • In-depth interviews -16 patients and 18 members of the research team


Methodology
Methodology non-curative cancer who have been invited to join a clinical research trial

  • Grounded Theory approach

  • In depth interviews with patients and Research Team (RT)

  • Data interlinked

  • Constraints of classic GT not doing data justice


Findings non-curative cancer who have been invited to join a clinical research trial

Research Staff

Patients

Nothing to Lose

Helping others

Trial information-balanced or skewed?

Trusting the research team

Increased personalised care

Privileged opportunity

Clinging to a straw

Selective hearing


Nothing to lose
Nothing to lose non-curative cancer who have been invited to join a clinical research trial

‘I just don’t think…. It’s a no brainer, really. If a consultant says to you, “Listen this is what we’ve got, an opportunity here to improve your situation. It hasn’t been done before. Would you be interested in doing it?” And you have nothing else. There is no other hope in the room, this is the only thing on the table, what are you going to do?’ (P01)


Trial information balanced or skewed
Trial information balanced or skewed non-curative cancer who have been invited to join a clinical research trial?

‘Mostly we are offering them a carrot that maybe this is the next magical drug for their disease…..I’d say, “I haven’t got another treatment that offers you any benefit and therefore we are hoping that this might be a drug that is the magical drug but it is a very long shot.” ’(RT14)


Increased personalised care
Increased personalised care non-curative cancer who have been invited to join a clinical research trial

‘She [clinical research nurse] says, “You will still be looked after the same way. You will still be getting the same appointments to come up. You will be coming up more often.” Which is what I want. I want to get a bit more attention. “You’ll be treated like a VIP” she says. I went, “That’s fine.” ’ (P06)


Privileged opportunity
Privileged opportunity non-curative cancer who have been invited to join a clinical research trial

  • Patients reported feeling lucky to be given the opportunity

  • Research team were unsurprised by this

    ‘Well I think if you are offered something that you have no access to ordinarily, I think that probably would make you feel special.’ (RT08)


Selective hearing
Selective hearing non-curative cancer who have been invited to join a clinical research trial

  • Trial acceptors showed a disregard for side-effects of trial drug

  • Some thought that trial participation might result in a cure

  • Research staff were aware of this stating that ‘they hear what they want to hear’ (RT08)


Clinging to a straw
Clinging to a straw non-curative cancer who have been invited to join a clinical research trial

‘I just want to live. I’ll take anything.’ (P02)

  • Patients were hopeful for life extension

  • For some a trial was the only treatment option

    ‘And so I sort of thought in one way it did give a sense of hope, that at least there are trials, but on the other hand you sort of think, he’s referring you to that, because he’s got nothing else.’ (P01)


Trusting the research team
Trusting the research team non-curative cancer who have been invited to join a clinical research trial

Many believed that their oncologist was offering them a trial because they believed it to be their best option

‘I didn’t think to bother to question it because I just took the view that they’re not going to give me something that’s absolutely stupid. I trust them and I’m not going to question this’. (P02)


Helping others
Helping others non-curative cancer who have been invited to join a clinical research trial

  • Research staff asserted that patients sometimes joined trials primarily to help others

  • No patients reported altruism as a primary reason for saying ‘yes’

    ‘I’m not trying to pretend that it’s all for someone else. I’m hoping that this treatment will be of benefit to me.’ (P04)


Research team non-curative cancer who have been invited to join a clinical research trial

Consensus

Patients

  • -Increased

    Care

    -Privileged

    -Trusting

    relationship

    -Clinging to a

    straw

Nothing to lose


Conclusions
Conclusions non-curative cancer who have been invited to join a clinical research trial

  • Trial participation makes patients feel special and endorses hopes for personal benefit

  • Participants agreed that trial benefit extended well beyond the drug available

  • Patients were aware of reality but held unrealistic hopes for personal benefit


Conclusions1
Conclusions non-curative cancer who have been invited to join a clinical research trial

  • Nothing to loseis a central themefor most participants

  • Consensus that trial participation offers last and best option

  • Groups differ on whether information is balanced or skewed

  • Patients have unconditional trust in their oncologists – impacting on “informed” consent process


Implications for practice
Implications for Practice non-curative cancer who have been invited to join a clinical research trial

  • The context is more important than the trial for patients’ decision making

  • The RT need to be mindful of patients’ trust

  • Trial participation may offer an alternative way for patients and HCPs to address End of Life issues


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