Smartphone-based distress screening, information provision, and psychotherapy for reducing psychological distress among AYA cancer survivors: protocol for a fully decentralized multicenter randomized controlled clinical trial

Jpn J Clin Oncol. 2024 Dec 7;54(12):1351-1357. doi: 10.1093/jjco/hyae111.

Abstract

Fear of cancer recurrence (FCR) is a common and distressing condition among adolescents and young adults (AYAs). This study aims to investigate the efficacy of digital interventions, including distress screening-based information provision and smartphone problem-solving therapy, on common psychological distress, especially FCR, in AYA patients with cancer. Participants will be 224 AYA outpatients with cancer aged 15-39 years who will be randomly assigned to either an 8-week smartphone-based intervention or a waitlist control group. This intervention includes smartphone-based distress screening, information provision, and psychotherapy (problem-solving therapy). The primary endpoint will be the Fear of Cancer Recurrence Inventory-Short Form score at week 8. This study will be conducted as a fully decentralized, randomized, and multicenter trial. The study protocol was approved by the Institutional Review Board of Nagoya City University on 19 April 2024 (ID: 46-23-0005). Trial registration: UMIN-CTR: UMIN000054583.

Keywords: AYA; decentralized clinical trial; digital intervention; psychotherapy; screening.

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Adolescent
  • Adult
  • Cancer Survivors* / psychology
  • Female
  • Humans
  • Male
  • Multicenter Studies as Topic
  • Neoplasm Recurrence, Local / psychology
  • Neoplasms / psychology
  • Neoplasms / therapy
  • Psychological Distress*
  • Psychotherapy* / methods
  • Randomized Controlled Trials as Topic
  • Smartphone*
  • Stress, Psychological / therapy
  • Young Adult