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

Tatsuo Akechi, Toshi A. Furukawa, Hiroya Hashimoto, Yoshihiko Harada, Yoshinori Ito, Yosuke Furukawa, Atsuko Kitano, Naoko Maeda, Yuki Kojima, Yuma Tada, Atsuko Watanabe, Akiko Kurata, Toshio Matsubara, Naomi Sakurai, Yosuke Uchitomi, Masako Okamura, Maiko Fujimori

Research output: Contribution to journalArticlepeer-review

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).

Original languageEnglish
Pages (from-to)1351-1357
Number of pages7
JournalJapanese Journal of Clinical Oncology
Volume54
Issue number12
DOIs
StatePublished - 1 Dec 2024

Keywords

  • AYA
  • decentralized clinical trial
  • digital intervention
  • psychotherapy
  • screening

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