title: The Melanoma care study: protocol of a randomised controlled trial of a psycho-educational intervention for melanoma survivors at high risk of developing new primary disease.
abstract: BACKGROUND
  Despite a good prognosis for most melanoma survivors, many experience substantial fear of new or recurrent melanoma, worry and anxiety about the future, and unmet healthcare needs. In this protocol, we outline the design and methods of the Melanoma Care Study for melanoma survivors at high risk of developing new primary disease. The objective of this study is to evaluate the efficacy and cost-effectiveness of a psycho-educational intervention for improving psychological and behavioural adjustment to melanoma risk.
  
  
  METHODS
  The study design is a two-arm randomised controlled trial comparing a psycho-educational intervention to usual care.
  
  
  METHODS
  The intervention is comprised of a newly-developed psycho-educational booklet and three telephone sessions delivered by a trained psychologist. A total of 154 melanoma survivors at high risk of developing new primary disease who are attending one of three melanoma high risk clinics in New South Wales, Australia, will be recruited. Participants will be assessed at baseline (6 weeks before their high risk clinic dermatological appointment), and then 4 weeks and 6 months after their appointment. If effectiveness of the intervention is demonstrated at 6 months, an additional assessment at 12 months is planned. The primary outcome is fear of new or recurrent melanoma, as assessed by the Fear of Cancer Recurrence Inventory (FCRI). Secondary outcomes include anxiety, depression, unmet supportive care needs, satisfaction with clinical care, knowledge, behavioural adjustment to melanoma risk, quality of life, and cost-effectiveness of the intervention from a health system perspective. Following the intention-to-treat principle, linear mixed models will be used to analyse the data to account for repeated measures. A process evaluation will also be carried out to inform and facilitate potential translation and implementation into clinical practice.
  
  
  CONCLUSIONS
  This study will provide high quality evidence on the efficacy and cost-effectiveness of a psycho-educational intervention aimed at improving psychological and behavioural adjustment amongst melanoma survivors at high risk of new primary disease.
  
  
  BACKGROUND
  ACTRN 12613000304730.
authors.affiliation: Cancer Epidemiology and Services Research, Sydney School of Public Health, The University of Sydney, The Lifehouse, Level 6 North, 119-143 Missenden Road, Camperdown, NSW 2050 Australia.
authors.forename: Mbathio
authors.initials: M
authors.lastname: Dieng
authors.affiliation: Discipline of Paediatrics, School of Women's and Children's Health, UNSW Medicine, The University of New South Wales, Sydney, NSW 2031 Australia.
authors.forename: Nadine A
authors.initials: NA
authors.lastname: Kasparian
authors.affiliation: Sydney School of Public Health, The University of Sydney, Sydney, NSW 2006 Australia.
authors.forename: Rachael L
authors.initials: RL
authors.lastname: Morton
authors.affiliation: Westmead Institute for Cancer Research, University of Sydney at Westmead Millennium Institute and Melanoma Institute Australia, Sydney, NSW 2145 Australia.
authors.forename: Graham J
authors.initials: GJ
authors.lastname: Mann
authors.affiliation: Centre for Medical Psychology and Evidence-based Decision-making, School of Psychology, University of Sydney, Sydney, NSW 2006 Australia.
authors.forename: Phyllis
authors.initials: P
authors.lastname: Butow
authors.affiliation: Discipline of Dermatology, The University of Sydney at The Sydney Melanoma Diagnostic Centre, Royal Prince Alfred Hospital, Camperdown, NSW 2050 Australia.
authors.forename: Scott
authors.initials: S
authors.lastname: Menzies
authors.affiliation: Psycho-oncology Co-operative Research Group, School of Psychology, University of Sydney, Sydney, NSW 2006 Australia.
authors.forename: Daniel S J
authors.initials: DS
authors.lastname: Costa
authors.affiliation: Cancer Epidemiology and Services Research, Sydney School of Public Health, The University of Sydney, The Lifehouse, Level 6 North, 119-143 Missenden Road, Camperdown, NSW 2050 Australia.
authors.forename: Anne E
authors.initials: AE
authors.lastname: Cust
keywords: Cancer; Intervention; Melanoma; Protocol; Psycho-education; Psychological stress; Randomised controlled trial; Recurrence