title: Observational study of the development and evaluation of a fertility preservation patient decision aid for teenage and adult women diagnosed with cancer: the Cancer, Fertility and Me research protocol.
abstract: Women diagnosed with cancer and facing potentially sterilising cancer treatment have to make time-pressured decisions regarding fertility preservation with specialist fertility services while undergoing treatment of their cancer with oncology services. Oncologists identify a need for resources enabling them to support women's fertility preservation decisions more effectively; women report wanting more specialist information to make these decisions. The overall aim of the 'Cancer, Fertility and Me' study is to develop and evaluate a new evidence-based patient decision aid (PtDA) for women with any cancer considering fertility preservation to address this unmet need.
  
  
  
  This is a prospective mixed-method observational study including women of reproductive age (16 years +) with a new diagnosis of any cancer across two regional cancer and fertility centres in Yorkshire, UK. The research involves three stages. In stage 1, the aim is to develop the PtDA using a systematic method of evidence synthesis and multidisciplinary expert review of current clinical practice and patient information. In stage 2, the aim is to assess the face validity of the PtDA. Feedback on its content and format will be ascertained using questionnaires and interviews with patients, user groups and key stakeholders. Finally, in stage 3 the acceptability of using this resource when integrated into usual cancer care pathways at the point of cancer diagnosis and treatment planning will be evaluated. This will involve a quantitative and qualitative evaluation of the PtDA in clinical practice. Measures chosen include using count data of the PtDAs administered in clinics and accessed online, decisional and patient-reported outcome measures and qualitative feedback. Quantitative data will be analysed using descriptive statistics, paired sample t-tests and CIs; interviews will be analysed using thematic analysis.
  
  
  
  Research Ethics Committee approval (Ref: 16/EM/0122) and Health Research Authority approval (Ref: 194751) has been granted. Findings will be published in open access peer-reviewed journals, presented at conferences for academic and health professional audiences, with feedback to health professionals and program managers. The Cancer, Fertility and Me patient decision aid (PtDA) will be disseminated via a diverse range of open-access media, study and charity websites, professional organisations and academic sources. External endorsement will be sought from the International Patient Decision Aid Standards (IPDAS) Collaboration inventory of PtDAs and other relevant professional organisations, for example, the British Fertility Society.
  
  
  
  NCT02753296; pre-results.
authors.affiliation: Department of Psychology, School of Social Sciences, Leeds Beckett University, City Centre Campus, Leeds, UK.
authors.forename: G L
authors.initials: GL
authors.lastname: Jones
authors.affiliation: Department of Psychology, School of Social Sciences, Leeds Beckett University, City Centre Campus, Leeds, UK.
authors.forename: J
authors.initials: J
authors.lastname: Hughes
authors.affiliation: Department of Psychology, School of Social Sciences, Leeds Beckett University, City Centre Campus, Leeds, UK.
authors.forename: N
authors.initials: N
authors.lastname: Mahmoodi
authors.affiliation: Department of Oncology, Sheffield Teaching NHS Hospitals Foundation Trust, Sheffield University, Sheffield, UK.
authors.forename: D
authors.initials: D
authors.lastname: Greenfield
authors.affiliation: Breast Cancer Care, London, UK.
authors.forename: G
authors.initials: G
authors.lastname: Brauten-Smith
authors.affiliation: Jessop Wing, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.
authors.forename: J
authors.initials: J
authors.lastname: Skull
authors.affiliation: Independent Cancer Patients' Voice, London, UK.
authors.forename: J
authors.initials: J
authors.lastname: Gath
authors.affiliation: Sheffield Children's Hospital NHS Foundation Trust, Sheffield, UK.
authors.forename: D
authors.initials: D
authors.lastname: Yeomanson
authors.affiliation: Seacroft Hospital, Leeds Teaching Hospitals, Leeds, UK.
authors.forename: E
authors.initials: E
authors.lastname: Baskind
authors.affiliation: Department of Haematology, Sheffield Teaching Hospitals NHS Foundation Trust, Royal Hallamshire Hospital, Sheffield.|Department of Oncology and Metabolism, University of Sheffield, Sheffield, UK.
authors.forename: J A
authors.initials: JA
authors.lastname: Snowden
authors.affiliation: School of Health and Related Research, University of Sheffield, Sheffield, UK.
authors.forename: R M
authors.identifier: 0000-0001-6710-5403
authors.initials: RM
authors.lastname: Jacques
authors.affiliation: University of Leeds, St James Hospital, Leeds Teaching Hospitals, Leeds, UK.
authors.forename: G
authors.initials: G
authors.lastname: Velikova
authors.affiliation: Centre for Health and Social Care Research, Sheffield Hallam University, Sheffield, UK.
authors.forename: K
authors.initials: K
authors.lastname: Collins
authors.affiliation: University of Leeds, St James Hospital, Leeds Teaching Hospitals, Leeds, UK.
authors.forename: D
authors.initials: D
authors.lastname: Stark
authors.affiliation: Center for Review and Dissemination, University of York, Leeds General Infirmary, Leeds Teaching Hospitals, York, UK.
authors.forename: R
authors.initials: R
authors.lastname: Phillips
authors.affiliation: Oxford Radcliffe Hospitals NHS Trust, Oxford, UK.
authors.forename: S
authors.initials: S
authors.lastname: Lane
authors.affiliation: Leeds Institute of Health Sciences, School of Medicine, University of Leeds, Leeds, UK.
authors.forename: H L
authors.initials: HL
authors.lastname: Bekker
mesh_terms: D000293:Adolescent; D000328:Adult; D003657:Decision Making; D003661:Decision Support Techniques; D005260:Female; D005298:Fertility; D059247:Fertility Preservation; D006296:Health Services; D006801:Humans; D007246:Infertility; D009369:Neoplasms / Q000628:therapy*; D010342:Patient Acceptance of Health Care; D010358:Patient Participation; D011446:Prospective Studies; D012107:Research Design; D006113:United Kingdom
keywords: Cancer; Decision aid; Decision-making; Fertility preservation; Protocol