Teenage cancer trials: a cause for hope
Improving outcomes for young people with bone cancer is being held back by participation levels, but signs are optimistic, reports Elaine Cole
Improving outcomes for young people with bone cancer is being held back by participation levels, but signs are optimistic
The survival rates for bone cancer, compared with other cancers, remain at 50-60% after 5 years. It has a peak incidence in teenagers and young adults (TYAs), but trials traditionally struggle to recruit from this age group, even though they are eligible for inclusion.
However, research exploring the perceptions and experiences of TYAs and their healthcare professionals of bone cancer trials has yielded potential strategies for increasing enrolment in the future.
The nurse-developed and led Bone Cancer Research Trust’s Perceptions of Patients and Professionals (BCRT PoPP) study about clinical trial participation is the first qualitative study on research recruitment and participation that integrates data from TYAs with cancer and their healthcare professionals.
The team was named winner of the Excellence in Cancer Research category of the prestigious RCNi Nurse Awards. The award, sponsored by Cancer Research UK (CRUK), is one of the profession’s top accolades.
The BCRT PoPP study team includes nurses Susie Pearce (principal investigator) and Alexandra Brownsdon from University College London Hospitals NHS Foundation Trust; Faith Gibson, London South Bank University and Great Ormond Street Hospital; and Verna Lavender, Oxford Brookes University.
Senior lecturer in cancer care Dr Lavender says: ‘Our aim was to improve outcomes for young people with bone cancer, which we know are influenced by participation in clinical trials.
‘New understandings emerged about the perceptions of this group and factors that influence participation in clinical trials. Addressing these factors may improve the acceptability and design of clinical trials for teenagers and young adults, ultimately improving their participation.’
How the study was carried out
The team conducted semi-structured interviews using narrative inquiry with 21 young people aged 15 to 24, and 18 health professionals.
The young people were eligible for recruitment to the Euramos-1 and Euro-Ewing-99 clinical trials and were interviewed 6-32 months post-diagnosis at a single TYA treatment centre. The researchers analysed transcripts using an interpretative approach to develop an emergent theoretical framework.
Oxford Brookes University senior lecturer in cancer care Verna Lavender says: ‘To gain an in-depth and broad understanding of the complexities of recruitment to, and participation in, these bone cancer clinical trials, we used a mixed methods approach to triangulate findings from interviews with teenagers and young adults, and health professionals.
‘Triangulating the data by integrating data sets from young people and health professionals was complex and required rechecking coding at each stage, but this added rigour to our study design and credibility, dependability and depth to the findings.
'The analysis was conducted by 4 members of the research team, none of whom had involvement with the clinical team, which added further dependability and trustworthiness to our findings.’
Another challenge was the presence of parents at some interviews. Dr Lavender says that although this was not actively encouraged, it reflects the teenager and young adult cancer care model.
‘The researcher kept the young person at the centre of the interview and prioritised their autonomy,’ she adds. ‘When parents spoke over them, they went back to the young people. In one sense we should have independently spoken to parents but there is only so much data that can be created with a sum of money.’
Specialist judge Anne Croudass, lead research nurse at CRUK, says: ‘This team’s excellent work has given us valuable insight into the needs of teenagers and young adults in the clinical trial setting. This will help us to develop best practice, boost trial recruitment and ultimately improve treatment for this often overlooked demographic.’
The BCRT PoPP study found factors that influenced the participation of TYAs included the importance and design of the clinical trial, age-specific communication, using language with which young people are comfortable, and support from family, peers and professionals. The treatment environment was also important, as was the involvement of a clinical nurse specialist (CNS).
Dr Lavender says: ‘Most of the young people were wavering and clear information from healthcare professionals, a sense of autonomy and being given information were important, as was knowing they could opt out at any time and that treatment was good and positive. Their treatment experience is difficult, with unscheduled admissions in general hospitals and time in intensive care.’
The importance of peer support
The young people recruited to the study highlighted the importance of being able to talk with peers with cancer, and specifically bone cancer, to receive information about their treatment and also to share their experience.
One young person said that had they been told things would have got better and easier, they would have stayed on the trial. Another spoke about how valued they felt being able to share common ground with a family whose son was very unwell, which provided the family with reassurance.
Oxford Brookes University senior lecturer in cancer care Verna Lavender says: ‘In the UK the treatment and care of young people with bone cancer is managed at supra-regional sarcoma centres, which will also be teenage and young adult principal treatment centres, so young people should have the opportunity to meet other young people with bone cancer.
'However, if that is not possible, cancer nurses should facilitate interaction between peers who have had a similar experience.’
Critical time points
There were critical time points, the study found. The time of clinical trial registration, soon after diagnosis when there was an imperative to start treatment urgently, was thought by many TYAs and healthcare professionals to be challenging.
Dr Lavender explains: ‘Consultations about consenting to randomised treatment coincided with difficult discussions about treatment response. We found that the prospect of prolonged treatment duration or increased treatment intensity on the experimental treatment arm often influenced the decision to participate.
‘What was interesting for me, coming from adult cancer, was that there wasn’t the same thinking about consenting. I perceived the trial as beneficial but it didn’t enter into their vocabulary.
'They spoke of their hate of being in hospital and asked “When is this going to finish?” They just want to get home. Having an understanding of that is crucial.
‘Some trusted parents to make the decisions and needed to abdicate. They were not equipped to make decisions. We recommend that teenagers and young people are given additional support at critical time points when significant decision making occurs.’
The importance of effective communication
The study found that effective, continuing, face-to-face communication was essential for sharing information about clinical trial participation involving teenagers and young adults (TYAs).
Communication should reflect a philosophy of age-appropriate care, prioritising the autonomy of the young person and keeping them at the centre of communication.
The CNS was regarded as a key professional to communicate complex information in language the young people were comfortable with, and acted as a trustworthy, knowledgeable and ‘neutral friend’.
Taking care with health professionals’ language was important. For example, the term ‘rare cancer’ added pressure to some TYAs’ decision whether to take part in the trial. ‘Poor responder’ could also conjure a negative reaction for some TYAs.
Dr Verna Lavender says: ‘We would recommend that health professionals are explicit when referring to tumour response to treatment, so that the young person does not feel it is they who have responded poorly, but understands the tumour has not responded well to the chemotherapy they have received.’
The CNS was especially important to this group as an impartial, but knowledgeable, ‘neutral friend’. ‘We might have to factor in funding for a CNS in clinical trials,’ says Dr Lavender. ‘We would like to see this formalised.’
Young people have better experiences and improved participation when nursed in TYA units. Organisations that lack units need to be aware that the treatment environment is significant.
Dr Lavender adds: ‘They have to make the young patient feel as at home as they can. If they want all their friends in for a laugh, then enable them to do that. If they want to check out from the ward and it is safe, let them. Let them get away from something that is really difficult.’
The team hopes the study will inspire research. Dr Lavender says: ‘We hope these findings, with further research, will ultimately contribute to strategies increasing enrolment and retention to clinical studies of teenagers and young people.’
Excellence in Cancer Research award finalists
Eileen Dillon, Cancer Research Nurse Team, Northern Ireland Cancer Trials Network
Managing a portfolio of 50-60 trials, the network’s 25 clinical research nurses have improved the care and experience of patients receiving new and developing treatments through their trial journey, from consent to treatment and afterwards.
Each acts as site coordinator and promoter, supporting preparation and training, liaising with research and clinical teams and support services. They coordinate the care of a caseload of patients during consent, screening and participation. A total of 9,040 participants have been recruited to 201 regional studies and more than 1,000 patients remain on follow up. Patient feedback is positive.
Elizabeth Wright, Home-testing of Blood Counts Post Chemotherapy Team, Leeds Teaching Hospitals NHS Trust
Senior research nurse Elizabeth Wright and research nurse Suzanne Rogerson have ensured a patient-centred approach to preparations for a groundbreaking study assessing the feasibility of chemotherapy patients home-checking their blood counts using a medical device.
The team conducted a feasibility survey of 107 oncology patients and, through workshops, ensured device designers understood the patients’ chemotherapy pathway and that the pathway for using the device was patient-focused. They will conduct qualitative research to capture the patient experience.
Elisabeth Turner, Senior research nurse, NIHR Clinical Research Network: North West Coast Taskforce
Elisabeth Turner has made a significant impact on a study aiming to improve methods of pancreatic reconstruction and promote enhanced recovery programmes for patients.
She has led and coordinated the implementation of PANasta – a one-to-one randomisation trial of two surgical techniques – at Royal Liverpool University Hospital.
She is responsible for the study’s conduct, patient safety and well-being, and the recruitment, coordination and continued organisation of trial patients, along with associated data and samples.