The Melanoma care study

Protocol of a randomised controlled trial of a psychoeducational intervention for melanoma survivors at high risk of developing new primary disease

Mbathio Dieng*, Nadine A. Kasparian, Rachael L. Morton, Graham J. Mann, Phyllis Butow, Scott Menzies, Daniel S J Costa, Anne E. Cust

*Corresponding author for this work

Research output: Contribution to journalArticle

9 Citations (Scopus)
1 Downloads (Pure)

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. Design: 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. Discussion: 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.

Original languageEnglish
Article number23
Pages (from-to)1-13
Number of pages13
JournalBMC Psychology
Volume3
Issue number1
DOIs
Publication statusPublished - 2015
Externally publishedYes

Bibliographical note

Copyright the Author(s) 2015. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.

Keywords

  • Cancer
  • Intervention
  • Melanoma
  • Protocol
  • Psycho-education
  • Psychological stress
  • Randomised controlled trial
  • Recurrence

Fingerprint Dive into the research topics of 'The Melanoma care study: Protocol of a randomised controlled trial of a psychoeducational intervention for melanoma survivors at high risk of developing new primary disease'. Together they form a unique fingerprint.

  • Cite this