Efficacy of a smartphone-based care support programme in improving post-traumatic stress in families with childhood cancer: protocol of a randomised controlled trial

BMJ Open. 2022 Sep 22;12(9):e060629. doi: 10.1136/bmjopen-2021-060629.

Abstract

Introduction: Diagnosis and treatment represent distressing experiences for the families of children with cancer. Psychosocial challenges are faced by these families in China because of limited health services and resources for psychosocial oncology care. Effective interventions tailored to the knowledge level and cultural values of this population are needed. The goal of this study is to evaluate a smartphone-based care support (SBCS) programme for the families of children with cancer in China.

Methods and analysis: A parallel randomised controlled trial will be conducted to examine the efficacy of an evidence-based and culturally tailored SBCS programme for the families of children with cancer in China. A total of 180 families will be recruited. The intervention will consist of an introduction session and four main sessions and will be conducted sequentially on a single weekend day. Participating families will be included in the intervention group. The post-traumatic stress and quality of life of families will be evaluated at baseline, during the intervention, immediately after the intervention, and 2 and 6 months after the intervention.

Ethics and dissemination: Ethical approval for this protocol has been obtained from the Nursing and Behavioural Medicine Research Ethics Review Committee, Xiangya School of Nursing, Central South University (Protocol #: E2020125). The findings of the trial will be disseminated through conference presentations and publications in peer-reviewed journals.

Trial registration number: ChiCTR2000040510.

Keywords: adverse events; change management; paediatric oncology; protocols & guidelines; quality in health care.

Publication types

  • Clinical Trial Protocol
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Child
  • Humans
  • Motivation
  • Neoplasms* / therapy
  • Quality of Life
  • Randomized Controlled Trials as Topic
  • Smartphone
  • Stress Disorders, Post-Traumatic* / therapy

Associated data

  • ChiCTR/ChiCTR2000040510