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

BackgroundDespite 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.DesignThe study design is a two-arm randomised controlled trial comparing a psycho-educational intervention to usual care.MethodsThe 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.DiscussionThis 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.Trial registrationACTRN 12613000304730

Psychoeducational intervention for people at high risk of developing another melanoma: a pilot randomised controlled trial

“…These findings inform the possible implementation of this model of psychological support in clinical care of patients with melanoma. We are currently carrying out a larger randomised controlled trial to evaluate the efficacy and cost-effectiveness of this intervention, comprising the full colour psychoeducational booklet and three telephone-based sessions with a psychologist compared with usual care 12. These findings will further inform the implementation of this model of psychological support in clinical care of patients with melanoma.…”

“…People who received five sessions participated in two additional sessions; the fourth occurred 1 week before their subsequent high-risk clinic appointment and the fifth occurred the following week. Two psychologists received extensive training in intervention delivery prior to trial commencement 12. With participants’ permission, all sessions were audiotaped and early sessions were reviewed by the clinical psychology supervisor (NAK), who also provided weekly supervision during which sessions were discussed in-depth.…”

“…Two psychologists received extensive training in intervention delivery prior to trial commencement. 12 With participants' permission, all sessions were audiotaped and early sessions were reviewed by the clinical psychology supervisor (NAK), who also provided weekly supervision during which sessions were discussed in-depth. Participants randomised to the control arm received the Cancer Council booklet 2 weeks before their 6-monthly high-risk clinic appointment.…”

“…Despite this, psychological support is not currently offered in Australian high-risk clinics that provide a specialised clinical service for people at very high-risk of primary melanoma11 nor have specific interventions been designed for this high-risk subgroup. To address this gap, our team developed a multifaceted psychological care programme for people at high-risk of developing another primary melanoma (the Melanoma Care Study ) 12. The intervention comprised up to five individual, telephone-based sessions with a psychologist, combined with an evidence-based psychoeducational booklet designed to respond to the unmet supportive care needs of people who have had melanoma.…”

“…To address this gap, our team developed a multifaceted psychological care programme for people at high-risk of developing another primary melanoma (the Melanoma Care Study). 12 The intervention comprised up to five individual, telephone-based sessions with a psychologist, combined with an evidence-based psychoeducational booklet designed to respond to the unmet supportive care needs of people who have had melanoma.…”