Protocol for a within-trial economic evaluation of a psychoeducational intervention tailored to people at high risk of developing a second or subsequent melanoma

M Dieng; A E Cust; N A Kasparian; P Butow; D S J Costa; S W Menzies; G J Mann; R L Morton

doi:10.1136/bmjopen-2016-012153

Protocol for a within-trial economic evaluation of a psychoeducational intervention tailored to people at high risk of developing a second or subsequent melanoma

BMJ Open. 2016 Oct 6;6(10):e012153. doi: 10.1136/bmjopen-2016-012153.

Authors

M Dieng¹, A E Cust^{1

2}, N A Kasparian³, P Butow⁴, D S J Costa^{4

5}, S W Menzies^{6

7}, G J Mann^{2

8}, R L Morton⁹

Affiliations

¹ Cancer Epidemiology and Prevention Research, Sydney School of Public Health, The University of Sydney, Sydney, New South Wales, Australia.
² Melanoma Institute Australia, The University of Sydney, North Sydney, New South Wales, Australia.
³ Discipline of Paediatrics, School of Women's and Children's Health, UNSW Medicine, The University of New South Wales, Sydney, New South Wales, Australia.
⁴ Psycho-oncology Co-operative Research Group, School of Psychology, The University of Sydney, Sydney, New South Wales, Australia.
⁵ Pain Management Research Institute, University of Sydney at Royal North Shore Hospital, St Leonards, New South Wales, Australia.
⁶ Discipline of Dermatology, Sydney Medical School, The University of Sydney, Camperdown, New South Wales, Australia.
⁷ The Sydney Melanoma Diagnostic Centre, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia.
⁸ Centre for Cancer Research, Westmead Institute for Medical Research, The University of Sydney, Westmead, New South Wales, Australia.
⁹ NHMRC Clinical Trials Centre, The University of Sydney, Camperdown, New South Wales, Australia.

Abstract

Introduction: Psychological support programmes are not currently funded for people with a history of melanoma. A major barrier to the implementation of effective psychological interventions in routine clinical care is a lack of cost-effectiveness data. This paper describes the planned economic evaluation alongside a randomised controlled trial of a psychoeducational intervention for people with a history of melanoma who are at high risk of developing new primary disease.

Method and analysis: The economic evaluation is a within-trial analysis to evaluate the incremental costs and health outcomes of a psychoeducational intervention compared to usual care from the perspective of the Australian healthcare system. Cost-effectiveness and cost-utility analyses will be conducted, providing estimates of the cost to reduce fear of melanoma recurrence and the cost per quality-adjusted life-year (QALY) gained. Fear of melanoma recurrence will be measured using the Fear of Cancer Recurrence Inventory and preference-based quality of life measured using the Assessment of Quality of Life-8 Dimensions (AQoL-8D) instrument. The AQoL-8D will provide utilities for estimation of QALYs in the cost-utility analysis. Unit costs of health services and medicines will be taken from the Medicare Benefits Schedule and the Pharmaceutical Benefits Scheme national databases. Health outcomes, and health service and medication use will be collected at baseline, 6 and 12 months follow-up. The within-trial analysis will be conducted at 12 months, consistent with the end point of the trial.

Ethics and dissemination: Approval to conduct the study was granted by the Sydney Local Health District (RPAH zone) Ethics Review Committee (X13-0065 and HREC/13/RPAH/86), the Department of Health and Ageing Human Research Ethics Committee (21/2013), the University of Sydney Human Research Ethics Committee (2013/595), and the Australian Institute of Health and Welfare Ethics Committee (EO 2013/4/58).

Trial registration number: ACTRN12613000304730; Pre-results.

Keywords: Cost-effectiveness analysis; Fear of cancer recurrence; Psychological intervention; QALY; cancer; cost-utility analysis.

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Australia / epidemiology
Cost-Benefit Analysis
Critical Pathways
Humans
Melanoma / economics
Melanoma / psychology*
Melanoma / therapy*
Neoplasm Recurrence, Local / economics
Neoplasm Recurrence, Local / psychology*
Neoplasm Recurrence, Local / therapy*
Patient Education as Topic / economics*
Patient Education as Topic / methods*
Quality of Life / psychology*
Randomized Controlled Trials as Topic
Risk Assessment

Associated data

ANZCTR/ACTRN12613000304730