Prevalence of adjustment disorder among cancer patients, and the reach, effectiveness, cost-utility and budget impact of tailored psychological treatment: study protocol of a randomized controlled trial

BMC Psychology

Femke Jansen¹  Florie E. van Beek¹  Pim Cuijpers¹  Irma M. Verdonck-de Leeuw¹  Veerle M. H. Coupé²  Birgit I. Lissenberg-Witte²  Lonneke M. A. Wijnhoven³  José A. E. Custers³  Judith B. Prins³  Marije L. van der Lee⁴  Eline J. Aukema⁵  Ben Wijnen⁶ 

[1] Department of Clinical, Neuro & Developmental Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam;Department of Epidemiology and Biostatistics, Amsterdam UMC, Vrije Universiteit Amsterdam;Department of Medical Psychology, Radboudumc Nijmegen, Radboud Institute of Health Sciences;Helen Dowling Institute for Psycho-Oncology;Ingeborg Douwes Centrum, Centre for Psycho-Oncology;Trimbos Institute;

关键词: Psychological intervention;    Cancer patients;    Psychological distress;    Adjustment disorder;    Randomized controlled trial;   

DOI  :  10.1186/s40359-019-0368-y

来源: DOAJ

【 摘 要 】

Abstract Background Information on the prevalence of adjustment disorders among cancer patients and the value of psychological interventions in this group of patients is limited. This study investigates the prevalence of adjustment disorders among cancer patients as well as the reach, effectiveness, cost-utility and budget impact of a tailored psychological intervention. Method This study consists of two parts. Part 1 is an observational study among a representative group of mixed cancer patients after cancer treatment on the prevalence of adjustment disorder as well as the uptake (i.e. reach) of psychological treatment. In Part 2, patients diagnosed with an adjustment disorder are invited to participate in a randomized controlled trial. Patients will be randomized to the intervention (access to the tailored psychological intervention) or control group (waitlist period of 6 months). The psychological intervention consists of three modules: one module containing psycho-education (3 sessions, all patients) and two additional modules (maximum of 6 sessions per module) provided as continuum, in case needed. Module 2 and 3 can consist of several evidence-based interventions (e.g. group interventions, mindfulness, eHealth) The primary outcome is psychological distress (HADS). Secondary outcomes are mental adjustment to cancer (MAC) and health-related quality of life (EORTC QLQ-C30). To assess the cost-utility and budget impact, quality of life (EQ-5D-5 L) and costs (iMCQ and iPCQ) will be measured. Measures will be completed at baseline and 3 and 6-months after randomization. Discussion This study will provide data of the prevalence of adjustment disorders and the reach, effectiveness, cost-utility and budget impact of a tailored psychological intervention. Trial registration Netherlands Trial Register identifier: NL7763. Registered on 3 June 2019.

【 授权许可】

Unknown