1. Developing a programme grant: the importance of feasibility work to inform design and conduct Dr Rachel Taylor Research Associate University College London & London South Bank University

2. Why the Essence of Care study? Teenage and Young Adult (TYA) cancer care experience relatively unknown Poorer outcomes in 15 – 24 year olds compared to children Increased interest in specialist TYA cancer care  NICE Children & Young people’s Improving Outcome Guidance  Internationally Critically asking for evidence of outcomes associated with TYA care

3. Aim To determine whether specialist TYA cancer care in England, for young people aged 13 – 24 years, is associated with improved outcomes during and after treatment BUT…

4. Challenges What study design?  Ideally randomised controlled trial, BUT Services are already in place Unethical to randomise to specialist care vs. not Variation in services across country What sample?  Too much variability to be single centre  National cohort, BUT How do you identify ALL young people? How do you recruit ALL young people? What outcomes?

5. Solution Feasibility studies

6. MRC framework for evaluating complex interventions

7. Essence of Care: Phase I

8. Study 1: Current & future policy underpinning TYA cancer Semi-structured interviews with four commissioners of TYA cancer services Documentary analysis of implementation plans  Progress reports from Sept ‘08 to Nov ‘09

9. What this informed… Aspects of study design:  Multi-centre, national

10. Study 2: Nature of TYA cancer care Non-participant observation  Single principle treatment centre  Observation over 2 weeks  All areas providing TYA cancer care Semi-structured interviews  Three health care professionals  Three young people

11. What this informed… Observation schedule for a multiple case study using non-participant observation Guided the sampling strategy for a multiple case study

12. Studies 3 - 5 Study 3: Towards a definition of TYA cancer care unit Study 4: Identifying the professional competencies for TYA cancer care Study 5: Young people’s experiences of cancer care  Workshops with young people and health professionals

13. Workshop participants Young people n = 11 (4 CCG) Age at diagnosis:  13 – 25 years Current age:  16 – 29 years All off treatment Health Care Professionals Two workshops n = 22 Clinical leads = 5 Doctors = 2 Nurses = 9 Other = 6

14. Study 3: Towards a definition of TYA cancer care unit Included in both young person and health professional workshop + ‘Find Your Sense of Tumour’ 2010 conference ‘Pyramid of importance’  Key features of a TYA cancer unit (identified from literature) + blank cards  Rank according to importance on a pyramid  Features given a rank score according to placement in pyramid

16. What this informed… Importance of involving young people if researching ‘experience’  Involve young people in study design  Involve young people in study conduct

17. Study 4: Identifying the professional competencies for TYA cancer care Included in the health professional workshop Diamond ranking  61 key skills, knowledge, attitudes (identified from a review of the literature) + blank cards  Rank on a diamond  Focus on the top half of the pyramid

19. What this informed… Highlighted the pattern of communication in TYA healthcare Initial survey for an international Delphi survey

20. Study 5: Young people’s experiences of cancer care Included in the workshop with young people Peer interviews  Conducted by the CCG (young person user group)  Concluded with a newspaper headline Spider diagram  Expansion of headlines through group discussion Group analysis with the CCG using thematic analysis of headlines & transcripts

21. What this informed… Quality of life as important as survival  Implication for primary outcome Basic framework for the Essence of Care Survey

22. Study 6: Self-reported outcome after treatment for cancer Literature review  Search terms related to outcome, i.e., quality of life  Cochrane + 4 databases  Young people aged 13 – 45 years with cancer (US definition of ‘young adult’)  Any study design  Study quality assessed with Cesario/CONSORT/STROBE guidelines

23. What this informed… Identify significant non-medical outcomes Understand young people’s experiences of cancer [care]  Underpin content of the Essence of Care Survey

24. Study 7: Outcome measures validated for young people aged 13 – 24 years Literature review  Search terms related to outcome, i.e., quality of life  Cochrane + 4 databases  Participants <16 years and ≥19 years  Only quantitative designs  Instrument quality assessed with McMaster Outcome Measure Rating Form

25. What this informed… Identify outcome measures that can be used in the Essence of Care study Develop a toolkit of outcome measures used in TYA, with a validity & reliability profile, for use in future research

26. Study 8: Evaluation of NHS datasets Aims  Identify young people within 90 days of diagnosis  To provide clinical data Review national datasets Criteria:  Population based  Minimum data: NHS number, name, gender, age, address, diagnosis & place of care

27. Results: identification of a dataset

28. What this informed… Cancer Waiting Time dataset had overall completeness of 99%  Young people can be identified within 90 days Only suspected therefore needs confirmation Additional data in other datasets  Clinical data available without relying on medical notes Quality of data is not confirmed Missing data Lack of reliable death data

29. Study 9: Young people’s preference for participation in a longitudinal study Recruitment in two principal treatment centres Six young people aged 17 – 21 years Complete outcome measures  PedsQL, INPATSAT, HUI2, EQ5D Semi-structured interviews

30. What this informed… Primary and secondary outcome measures Study design issues Importance of involving young people in study design

31. Study 10: Framework for the Essence of Care study Challenges for Phase II  Can we identify all newly diagnosed young people in England in 2012?  How can they be recruited??????  How can data be collected?????? Yes

32. Solutions NIHR funded project = access to NCRN nurses  Will they recruit young people? Search existing national cohort studies (e.g. Millennium Cohort Study) How do they data collect?  Commercial research companies  Is this economically feasible? Yes

33. The 2012 TYA Cancer Cohort Study UCLH: Dr Jeremy Whelan (CI) Susie Pearce Martin Lerner UCL: Dr Julie Barber Professor Steve Morris Professor Rosalind Raine Dr Rachel Taylor University of Leeds: Dr Richard Feltbower St James’ University Hospital Dr Dan Stark Cancer Research UK Dr Lorna Fern GOSH/LSBU Professor Faith Gibson NCAT Louise Hooker NWCIS Dr Tony Moran Dr Catherine O’Hara NCRI CSG TYA CCG: Hannah Millington

34. Workstream 1: the description of specialist TYA cancer care Explore the culture of care through non- participant observation, interviews and documents analysis Identify the specialist competencies and added value of specialist health professionals through a Delphi survey Validate a bespoke scale to categorise 3 levels of TYA care (TYA Cancer Specialism Scale)

35. Workstream 2: cohort study of all TYA diagnosed during an 18 month period Accrual within 3 months of diagnosis and follow- up will continue for 3 years Relate the level of specialist care received to:  Patient reported outcome  Clinical processes and outcomes  Experience of cancer care  Achieving social and educational milestones  Geographic and socio-demographic inequalities

36. Workstream 3: health economics Compare costs to the NHS and personal social services between TYA receiving different levels of specialist care Estimate the cost to TYA and families of specialist care Calculate the cost effectiveness of different levels of TYA care Workstream 4: intervention development & service evaluation

37. Summary Complex evaluation of health care need complex study designs MRC framework for evaluating complex interventions  Importance of feasibility & pilot studies NIHR recognition  Programme development grant

38. Conclusion So how did we do?  Stage 1 submission: March 2010  Reviewer feedback: May 2010  Stage 2 submission: October 2010  Sub-panel comments: March 2011  Amended submission: May 2011 Outcome?

39. Dr Lorna Fern Professor Faith Gibson Dr Catherine O’Hara Susie Pearce Dr Rachel Taylor Dr Jeremy Whelan Research team: Phase I NCRI Clinical Studies Group Teenage & Young Adult Core Consumer Group  James Ashton  Katie Brooman  Tom Grew  Hannah Millington  Carol Starkey

40. Acknowledgements Teenage Cancer Trust for funding the ‘Essence of Care’ project Carol Irving & David Wright for their support with the CCG Professor Ian Lewis, Dr David Hobin & members of TYAC for permission to work with their data Participants & Steering Committee of ‘Find Your Sense of Tumour’