Lorna A Fern

Rates of inclusion of teenagers and young adults in England into National Cancer Research Network clinical trials: Report from the National Cancer Research Institute (NCRI) Teenage and Young Adult Clinical Studies Development Group

Poor inclusion rates into clinical trials for teenagers and young adults (TYA; aged 13–24 years) have been assumed but not systematically investigated in England. We analysed accrual rates (AR) from 1 April 2005 up to 31 March 2007 to National Cancer Research Network (NCRN) Phase III trials for the commonest tumour types occurring in TYA and children: leukaemia, lymphoma, brain and central nervous system, bone sarcomas and male germ cell tumours. AR for 2005–2007 were 43.2% for patients aged 10–14 years, 25.2% for patients aged 15–19 years, and 13.1% for patients aged 20–24 years in the tumour types analysed. Compared with accrual from 1 April 2005 to 31 March 2006, AR between 1 April 2006 and 31 March 2007 increased for those aged 10–14 and 15–19 years, but fell for those aged 20–24 years. AR varied considerably among cancer types. Despite four trials being available, patients over 16 years with central nervous system tumours were not recruited. Rates of participation in clinical trials in England from 2005 to 2007 were much lower for TYA older than 15 years compared with children and younger teenagers. The variations in open trials, trial age eligibility criteria and extent of trial activation in treatment centres in part explain this observation. Other possible influences, such as difficulties associated with the consent of TYA require further evaluation. Closer dialogue between those involved in planning and running trials for children and for adults is necessary to improve trial availability and recruitment. Further research is required to identify trends in trial availability and accrual for those tumours constituting the remaining 26% of TYA cancers.

Recruitment of Adolescents and Young Adults to Cancer Clinical Trials—International Comparisons, Barriers, and Implications

The last 30 years have seen significant improvements in survival rates for children and older adults. In contrast, the 5-year survival rate among 20 to 39 year olds has been static at around 70% since 1986. Data from the United States, Australia, Italy, and the United Kingdom suggest that this age group also has the lowest rate of clinical trial participation. In the United States, just 2% of patients aged 20 to 29 years enter trials, in contrast with an estimated 60% of patients under 15 years of age. In the United Kingdom, the nadir in accrual is for patients aged 35 to 39 years, of whom only 7.5% are recruited, compared to 52.7% of patients below 15 years of age. This level of trial activity may be associated with the lack of improvement in survival for the older age group. Strategies to increase the numbers of adolescents and young adults (AYA) recruited to cancer clinical trials have become a focus of research activity in several countries. This article explores possible barriers to recruitment of AYA and summarizes current policies in the United States and the United Kingdom to increase accrual of young adults with cancer to clinical trials.

Available, accessible, aware, appropriate, and acceptable: a strategy to improve participation of teenagers and young adults in cancer trials

Under-representation of teenagers and young adults in clinical trials for cancer is acknowledged internationally and might account for the lower survival gains noted for this group. Little research has focused on strategies to increase participation of teenagers and young adults in clinical trials. We applied a conceptual framework for barriers to recruitment of under-represented populations to data for cancer clinical trials in teenagers and young adults. We did a systematic analysis of data for clinical trial enrolment in Great Britain over 6 years (2005-10), and reviewed the published work for the origins and scientific rationale of age eligibility criteria in clinical trials for cancer. Our Review revealed little scientific evidence for use of age eligibility criteria in cancer clinical trials. Participation in cancer trials fell as age increased. Between 2005 and 2010, participation rates increased for children and young people aged 0-24 years. The highest increase in participation was for teenagers aged 15-19 years, with smaller improvements in rates for 20-24 year olds. Improvements were related to five key criteria, the five As: available, accessible, aware, appropriate, and acceptable. In studies for which age eligibility criteria were appropriate for inclusion of teenagers or young adults or amended during the study period, participation rates for 15-19 year olds were similar to those for 10-14 year olds. We propose a conceptual model for a strategic approach to improve recruitment of teenagers and younger adults to clinical trials for cancer, with use of the five As, which is applicable worldwide for investigators, regulatory authorities, representatives in industry, policy makers, funders, and health-care professionals.

The Art of Age-Appropriate Care: Reflecting on a Conceptual Model of the Cancer Experience for Teenagers and Young Adults

Background: There is recognition that teenagers and young adults with cancer merit age-appropriate specialist care. However, outcomes associated with such specialist care are not defined. Patient experience and patient-reported outcomes such as quality of life are gaining importance. Nevertheless, there is a lack of theoretical basis and patient involvement in experience surveys for young people. Objective: We previously proposed a conceptual model of the lived experience of cancer. We aimed to refine this model adding to areas that were lacking or underreported. The proposed conceptual framework will inform a bespoke patient experience survey for young people. Methods: Using participatory research, 11 young people aged 13 to 25 years at diagnosis, participated in a 1-day workshop consisting of semistructured peer-to-peer interviews. Results: Eight core themes emerged: impact of cancer diagnosis, information provision, place of care, role of health professionals, coping, peers, psychological support, and life after cancer. Conclusions: The conceptual framework has informed survey development for a longitudinal cohort study examining patient experience and outcomes associated with specialist cancer care. Implications for Practice: Young people must be kept at the center of interactions in recognition of their stated needs of engagement, of individually tailored information and support unproxied by parents/family. Age-appropriate information and support services that help young people deal with the impact of cancer on daily life and life after cancer must be made available. If we are to develop services that meet need, patient experience surveys must be influenced by patient involvement. Young people can be successfully involved in planning research relevant to their experience.

Developing a conceptual model of teenage and young adult experiences of cancer through meta-synthesis.

OBJECTIVES To systematically identify and analyse published research exploring teenage and young adult experience of cancer to inform the development of a patient-reported outcome survey intended to explore if a correlation exists between specialist cancer care and quality of life for young people with cancer. DESIGN Systematic review and meta-synthesis. DATA SOURCES Medline, CINAHL Plus and PsycInfo were searched for literature published between 1987 and 2011. REVIEW METHODS Search terms included those for: population (e.g. teen, young adult); intervention (e.g. cancer); outcome (e.g. experience); and study type (e.g. qualitative). INCLUSION CRITERIA adolescents and young adults were both represented; diagnosis of cancer; published in English; and used qualitative methods to report an aspect of the cancer experience. Studies were excluded if they were reporting: palliative care experience; secondary data; or proxy views, i.e. parent or health professional perspective. Methodological quality was assessed using Cesario criteria and meta-synthesis involved deconstruction and decontextualising findings to identify common themes. RESULTS Three hundred and fifteen studies were identified, 17 fulfilled the inclusion criteria. Of these, most (59%), were assessed as being high quality, none were rated poor. Nine common themes were identified: psychosocial function, importance of peers, experience of healthcare, importance of support, impact of symptoms, striving for normality, impact of diagnosis, positive experiences, and financial consequences. CONCLUSIONS The conceptual model developed from the meta-synthesis depicts the mediators and consequences of cancer care that impact on young peoples quality of life after a cancer diagnosis. The model highlights areas that require further exploration.

Development and validation of the BRIGHTLIGHT Survey, a patient-reported experience measure for young people with cancer

BackgroundPatient experience is increasingly used as an indicator of high quality care in addition to more traditional clinical end–points. Surveys are generally accepted as appropriate methodology to capture patient experience. No validated patient experience surveys exist specifically for adolescents and young adults (AYA) aged 13–24 years at diagnosis with cancer. This paper describes early work undertaken to develop and validate a descriptive patient experience survey for AYA with cancer that encompasses both their cancer experience and age-related issues. We aimed to develop, with young people, an experience survey meaningful and relevant to AYA to be used in a longitudinal cohort study (BRIGHTLIGHT), ensuring high levels of acceptability to maximise study retention.MethodsA three-stage approach was employed: Stage 1 involved developing a conceptual framework, conducting literature/Internet searches and establishing content validity of the survey; Stage 2 confirmed the acceptability of methods of administration and consisted of four focus groups involving 11 young people (14–25 years), three parents and two siblings; and Stage 3 established survey comprehension through telephone-administered cognitive interviews with a convenience sample of 23 young people aged 14–24 years.ResultStage 1: Two-hundred and thirty eight questions were developed from qualitative reports of young people’s cancer and treatment-related experience. Stage 2: The focus groups identified three core themes: (i) issues directly affecting young people, e.g. impact of treatment-related fatigue on ability to complete survey; (ii) issues relevant to the actual survey, e.g. ability to answer questions anonymously; (iii) administration issues, e.g. confusing format in some supporting documents. Stage 3: Cognitive interviews indicated high levels of comprehension requiring minor survey amendments.ConclusionCollaborating with young people with cancer has enabled a survey of to be developed that is both meaningful to young people but also examines patient experience and outcomes associated with specialist cancer care. Engagement of young people throughout the survey development has ensured the content appropriately reflects their experience and is easily understood. The BRIGHTLIGHT survey was developed for a specific research project but has the potential to be used as a TYA cancer survey to assess patient experience and the care they receive.

A scoping exercise of favourable characteristics of professionals working in teenage and young adult cancer care: 'thinking outside of the box'

GIBSON F., FERN L., WHELAN J., PEARCE S., LEWIS I.J., HOBIN D. & TAYLOR R.M. (2012) European Journal of Cancer Care21, 330–339 A scoping exercise of favourable characteristics of professionals working in teenage and young adult cancer care: ‘thinking outside of the box’ A scoping exercise to define the preferred competencies of professionals involved in teenage and young adult (TYA) cancer care. Data were generated during two workshops with health professionals. In groups, they ranked skills, knowledge and attitudes, previously identified through a literature search, onto a diamond template. Data were also used from an education day with TYA professionals, who generated lists of key skills, knowledge and attitudes. Individually, professionals then selected the top five areas of competence to care for young people with cancer. The workshops generated three diamonds, which exhibited agreement of 13 principle skills, knowledge and attitudes. The top two being: ‘expertise in treating paediatric and adult cancers’ and ‘understanding cancer’. The data from the education day suggested communication, technical knowledge and teamwork as being core role features for professionals who care for young people with cancer. Integration of both datasets; one derived inductively, the other deductively provides a comprehensive outline of core skills health professionals require to be proficient in young peoples cancer care. These results will form the basis of future discussion around workforce strategies and inform a Delphi survey.

“Your Place or Mine?” Priorities for a Specialist Teenage and Young Adult (TYA) Cancer Unit: Disparity Between TYA and Professional Perceptions

PURPOSE To identify key components of a specialist teenager and young adult (TYA) cancer unit from the perspective of young people and health professionals. PATIENTS AND METHODS A facilitated workshop was held in England at which participants prioritized 15 core features of a specialist cancer unit identified in a literature review. Themes were transferred onto cards and organized using a pyramid. Notes were made of the discussion and how decisions were reached. The exercise was repeated in a survey at a patient conference. Data were analyzed by weighting the ranked position and by content analysis. RESULTS Eleven young people and 22 health professionals attended the workshops, and 64 young people completed the survey. Young peoples top three priorities were a dedicated unit, contact with peers, and provision for partners/parents to live in the unit with them. Health professionals prioritized best chance of survival and best quality of life, access to expertise, access to computers/Internet, and age-appropriate equipment. CONCLUSIONS Priorities varied across and within healthcare professionals and young people, and were dependent on viewpoint and personal experience. This is an essential first step toward a fuller description of the benefit of specialist TYA cancer services and highlights the importance of consulting users in service development.

National Cancer Research Institute Teenage and Young Adult Clinical Studies Group: The United Kingdom Approach to Research. International Perspectives on AYAO, Part 4.

The unique psychosocial needs of teenagers and young adults (TYAs) with cancer have been recognized for some time in the United Kingdom. The non-profit Teenage Cancer Trust pioneered dedicated units for TYAs in 1990, and by 2005, the United Kingdom National Institute for Health and Clinical Excellence (NICE) issued healthcare policy advocating age-appropriate care. The National Cancer Research Institute Teenage and Young Adult Clinical Studies Group (NCRI TYA CSG) was also established in 2005. This national research group promotes and generates research specifically for TYAs with cancer, broadly those aged 13-24 years at diagnosis. The work of the TYA CSG to date has focused on six themes: (1) benchmarking clinical trial availability and access for TYAs; (2) developing links with other NCRI tumor-specific Clinical Studies Groups; (3) identifying priority areas for health services research; (4) evaluating the requirement for a cancer registry function for TYAs; (5) identifying issues for late effects and survivorship; and (6) identifying host- and tumor-specific biological differences in TYA cancer. Here we describe some of the research developments of the NCRI TYA CSG in the context of cancer research in the United Kingdom and healthcare policy for TYAs.

Novel participatory methods of involving patients in research: naming and branding a longitudinal cohort study, BRIGHTLIGHT.

BackgroundPatient and public involvement (PPI) is central to research and service planning. Identifying effective, meaningful ways of involvement is challenging. The cohort study ‘Do specialist services for teenagers and young adults with cancer add value?’ follows young people for three years, examining outcomes associated with specialist care. Participant retention in longitudinal research can be problematic potentially jeopardising study completion. Maximising study awareness through high impact branding and publicity may improve study retention. Study names are typically generated by researchers rather than designed with patients.We aimed to involve young people in developing a brand identity and name to ‘Do specialist services for teenagers and young adults with cancer add value?’.MethodsNine young people aged 17–26 years diagnosed with cancer when aged 14–25 years participated in a one day workshop with further data collection at a patient conference. Methodology was similar to conventional branding and naming exercises and was divided into six stages. The workshop comprised five stages. Stage 1: ‘What’s in a brand’ allowed young people to enquire why brands/logos are important, Stage 2: ‘Brand Transformation’ identified what young people needed to know and believe about the study when approached about participation, Stage 3: ‘Brand Essence’ determined how we wanted the study to be perceived by young people, Stage 4: ‘What’s in a name’ identified potential names for the study. Stage 5: ‘Logo creation’ assembled the mood and feel of logos. Stage 6 was logo design and an electronic survey of 249 young people attending a patient conference.ResultsBRIGHTLIGHT was the final study name and the brand essence (or study personality) was friendly, supportive and inspiring. Four logos were designed and the final logo received 47% (n = 115) of votes.ConclusionsAcceptance and retention to BRIGHTLIGHT is higher than anticipated (80% versus 60%), this may be related to our integral PPI strategy. We propose this reproducible methodology as an important, enjoyable, and novel way of involving patients in research and a welcome alternative to researcher-developed acronyms. Ideally this should be carried out prior to engaging with healthcare professionals to prevent confusion around study identity.