A workbook- and audio-administered, telephone-guided, low-intensity cognitive behavioural therapy intervention (EJDeR) for parents of persons treated for cancer during childhood: protocol for the CHANGE-pilot randomised controlled trial.

چکیده اصلی

INTRODUCTION: Childhood cancer and its treatment place substantial demands on parents, causing significant disruptions in multiple areas of life. Parents report psychological, psychosocial, and economic consequences related to their child's illness. In Sweden, psychosocial support is available to parents via paediatric oncology care during cancer treatment; however, only a minority of parents have access to psychological support after treatment completion. Increasing and improving access to such support could enhance parental mental well-being and help prevent or alleviate negative consequences. One potential solution to provide support is the EJDeR intervention, a co-created workbook- and audio-administered, telephone-guided, low-intensity cognitive behavioural therapy (LICBT) intervention for parents of persons treated for cancer during childhood. Objectives are to examine the feasibility of (1) EJDeR delivered via workbooks, audio files and video case vignettes with telephone guidance from a parent guide, and (2) planned study procedures for a future superiority randomised controlled trial of EJDeR. METHODS AND ANALYSIS: This is a parallel-group, two-arm, pilot randomised controlled trial with a 1:1 allocation ratio. A Parent Advisory Board (PAB) contributes to the research. We aim to recruit 60 parents of persons diagnosed with cancer at age 0-18 years whose treatment was completed 3 months to 5 years earlier. Participants will be randomly allocated to EJDeR plus usual care or usual care alone. EJDeR is delivered over 12 weeks via workbooks, audio files and video case vignettes, with telephone guidance from a parent guide. We will examine feasibility outcomes related to procedural, intervention, and methodological uncertainties using a priori progression criteria following a GO-AMEND-STOP progression framework. We will measure clinical (mental well-being, symptoms of depression, anxiety, and post-traumatic stress) and health economic (health-related quality of life and societal resource use) outcomes at baseline, post-treatment (12 weeks), and follow-up (6 months post-treatment). Data analysis is primarily descriptive. ETHICS AND DISSEMINATION: This trial was approved by the Swedish Ethical Review Authority (Dnr 2025-09024-01, approval date: 2 February 2026). We will obtain written informed consent from all participants and disseminate findings in collaboration with the PAB through peer-reviewed publications, conference presentations, and non-academic dissemination activities such as co-writing plain language summaries and dissemination via childhood cancer organisations. TRIAL REGISTRATION NUMBER: ISRCTN51549508.

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