Background
Methods
Study aim
Study design
Participants
Recruitment
Interviews
Data analysis
Results
Participant | Gender | Cancer Diagnosis | Trial Phase | Accept trial? | Time from initial interview to death |
---|---|---|---|---|---|
P01 | F | Breast | I | Yes | 10 weeks |
P02 | M | Oesophagus | III | Yes | 16 months |
P03 | F | Pancreatic | III | No | 7 weeks |
P04 | M | Prostate | III | Yes | Alive |
P05 | F | Breast | I | Yes | 3 months |
P06 | M | Prostate | III | Yes | 29 months |
P07 | M | Prostate | III | No | 3 months |
P08 | M | Prostate | III | Yes | Alive |
P09 | M | Colorectal | II | Yes | 16 months |
P10 | M | Pancreatic | III | Yes | 17 months |
P11 | M | Pancreatic | III | Yes | 11 months |
P12 | F | Myeloma | III | Yes | Alive |
P13 | M | Pancreatic | III | No | 6 months |
P14 | M | Colorectal | II | Yes | 5 months |
P15 | F | Breast | I | Yes | 9 months |
P16 | M | Liver | III | Yes | 14 months |
Category 1 (core category) – NOTHING TO LOSE
This core category conveyed a fairly desperate situation, where time was running out and in the face of a dire prognosis, everyone – patients and professionals alike - were searching for a “life-line”. Conversely, the three patients who declined the offer of a clinical trial, did so after much deliberation. They felt they had ‘nothing to lose’ by saying ‘no’ to a clinical trial and instead opted for standard chemotherapy – which for them seemed a safer option.‘It’s a “no brainer”, really. If a consultant says to you, “Listen, 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)
Category/ subcategory | Excerpt (patient participants are italicized) |
---|---|
1. NOTHING TO LOSE (core category) | ‘I didn’t want to say too much. I told them (family) I’m going on a drug trial. But that’s where it stops. I said, “They offered me a drug trial. I have nothing to lose.” And they says, “Well that’s all right, go ahead, do what you need to do.” (P06) ‘I’m not gonna commit to 2 years of the rest of my life to that.’ (P07 – trail decliner) ‘I think if people didn’t think, or didn’t hope that they would get life extension, no matter how well we brief them, I doubt they would actually take part in Phase I trials.’ (HcP01) |
1.a Just want to live (subcategory) | ‘When it comes to dying or anything there’s no way, like my own view is I’m too miserable to die. I’ve too much to do and I’ve a whole lot of things more that I haven’t had any time for dying.’ (P10) |
1.b Maintaining hope (Subcategory) | ‘We ourselves are going to be hopeful that it is [the trial] going to bring some benefit. Even for Phase I studies, it is highly unlikely that you would be in a situation and caring for somebody and just thinking ...you know, you do feel that there is a possibility of individual benefit. You want that to work for them. We are delivering this in a caring therapeutic setting.’ (HcP18) |
2. TRUSTING RELATIONSHIP (Category) | “It’s all mind games in this disease, it feels like he is a friend in a sense because he is the one who is going to treat me for this disease … he’s the one that is working to make things better for me.” (P01) ‘We didn’t know really whether it would be a good or bad thing. We just wanted to talk to [GP] - somebody with more experience about it.’ (P03 - trail decliner) ‘I know that it is sometimes a scary position to be in, to be the trusted doctor, especially if you have been looking after them for a number of years, they will do anything you ask them.’ (HcP10) |
2.a Feel lucky (Subcategory) | ‘She [clinical research nurse] says, “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) |
2.b Personalised Care (Subcategory) | ‘My view is that the best quality care that I can provide for a patient is through consideration for clinical trials. They drive high quality care. They may not provide the answer but in the process of doing it, they provide a very strong methodological framework to carry out high quality clinical care. So my commitment to patients is to carry out the best care I possibly can.’ (HcP06) |
3. FIGHTING CANCER (Category) | ‘Now it’s just a matter of ‘here we go again’. It’s just the circle of life. It’s part of my life and cancer is a big part of my life. But dying is not part of my life... So, fighting the cancer is just what I have to do.’ (P15) “These patients would grab anything to fight this disease.” (HcP02) |
3a.Self concern (Subcategory) | ‘Well I am being totally selfish in my trial... Because the part of the trial that might help people in the future, I don’t really care at this stage, I just want to live myself. I’m not in a situation to start thinking about other people’s cures in the future. I need my own treatment now.’ (P14) |
3b. Altruistic Motivation (Subcategory) | ‘Most people still ultimately – they may tell themselves they are only doing it for altruistic reasons, but I think ultimately most people are doing it because they think it is the best thing for them. But the altruism still weighs very, very highly for them. I think there are a few individuals who just say, “Well I’ve got two options. I can have treatment, or I can have treatment which is going to help other people more, so I am going to do that.” (HcP06) |
Subcategory 1.a - I just want to live (patients)
Incongruous perceptions were apparent, in that individual patients were aware that their cancer was incurable, but still hoped that the trial drugs might provide a cure. The concept of ‘hope’ was recurrent and a key ‘driver’ for patients to do something to extend life. It is evident that the power of their hope - or perhaps their desperation - is such that they ‘cling-on’ to any possibility that their cancer can “go away”.‘They no longer think they can get rid of my cancer anymore. If it works really well, the chemo combined with the trial drug, can make the cancer go away, can shrink it significantly, can shrink it a little bit, or can stop it growing. And I would like the best of those options-to make it go away.’ (P14)
Subcategory 1.b - Maintain hope (healthcare professionals)
There was consensus amongst professionals, that this group of patients would ‘grab anything’ (HcP02), because ‘there is nothing else and that is the long and short of it.’ (HcP13). In this situation they didn’t want to ‘dash hope’, accepted a ‘degree of false hope’ on the patients’ behalf and always sought to have ‘something else to offer’, even as they conveyed bad news.‘I think if people didn’t think, or didn’t hope that they would get life extension, no matter how well we brief them, I doubt they would actually take part in Phase I trials.’ (HcP01)
Category 2 - TRUSTING RELATIONSHIP
Patients looked to their oncologist for guidance and described having ‘absolute trust’ (P01) and ‘implicit trust’ (P02) in their doctor. Some also expressed feelings of friendship with their Oncologist (see P01, Table 2, section 2). The healthcare professionals were aware of the trust that patients placed in them and were sometimes daunted by that responsibility: ‘they will do anything you ask of them’ (HcP10, Table 2).‘I would have gone on the trial anyway, cos of the trust I have in Dr S already. If he said, “Go get chemo with us [standard treatment]” or, “Chemo on the trial is better than chemo outside the trial.” I would have said, “Of course.”’ (P14)
Subcategory 2.a - Feel lucky (patients)
This excitement seemed to centre around the fact that they were going to receive a ‘new and expensive’ drug. Many patients in the study made their decision to join a trial prior to receiving detailed trial information, indicating their decision was an instinctive response – which may have been facilitated by the trusting relationship already described.‘But you are also being given this chance. So, you’re selected and you’re (thinking) - I’m probably the only person in Northern Ireland getting this drug at the moment. It makes me feel very lucky.’ (P14)
Subcategory 2b - Personalised care (healthcare professionals)
Even randomization to the standard care arm of the trial was perceived positively. There was general agreement from healthcare professionals that being in a clinical trial optimises the care experience. Patients also believed that they were getting increased personalised care as part of the clinical trial, though more frequent hospital visits were perceived negatively by trail decliners.‘We would love to think that patients on standard management get optimal management all the time, but they don’t. Research participants have got the research team following them up and all the things that are supposed to happen – do. So, if you like, they have got optimal care.’ (HcP16)
Category 3 - FIGHTING CANCER
From the data, it seemed that on occasion patients would have considered anything that was offered. Both patients and professionals described themselves as being in a battle against the mutual enemy - cancer. Healthcare professionals understood this was a life and death situation for the patients and therefore always wanted to ‘have something else to offer them’ (HcP11).‘Now it’s just a matter of “here we go again”. It’s just the circle of life. It’s part of my life and cancer is a big part of my life. But dying is not part of my life... So, fighting the cancer is just what I have to do.’ (P15)
Subcategory 3a - Self Concern (patients)
This excerpt exemplifies the strong desire that these patients have to continue living for as long as possible. There was no sense in the patient data that their decision was altruistic - in fact, most presented as very single-minded and the motivation was exclusively focused around their personal benefit.‘Well I am being totally selfish in my trial … being part of the trial might help people in the future, but I don’t really care at this stage, I just want to live myself. I’m not in a situation to start thinking about other people’s cures in the future. I need my own treatment now.’ (P14)
Subcategory 3.b - Altruistic motivation (healthcare professionals)
It is interesting that this is the only subcategory where data from the patients and healthcare professionals are at odds with each other. It is unclear from the data provided in this study why there was a discrepancy between patient and professional on this particular aspect.‘ … And so I think for many people that is a very big driver … it’s actually the driver of helping us to learn more to help other people.’ (HcP06)