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

doi:10.1093/jjco/hyae111

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 Aug 28:hyae111. doi: 10.1093/jjco/hyae111. Online ahead of print.

Authors

Tatsuo Akechi^{1

2}, Toshi A Furukawa³, Hiroya Hashimoto⁴, Yoshihiko Harada^{1

2}, Yoshinori Ito², Yosuke Furukawa², Atsuko Kitano⁵, Naoko Maeda⁶, Yuki Kojima⁷, Yuma Tada⁸, Atsuko Watanabe⁹, Akiko Kurata¹⁰, Toshio Matsubara¹¹, Naomi Sakurai¹², Yosuke Uchitomi¹³, Masako Okamura¹⁴, Maiko Fujimori¹⁴

Affiliations

¹ Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.
² Division of Palliative Care and Psycho-oncology, Nagoya City University Hospital, Nagoya, Japan.
³ Kyoto University Office of Institutional Advancement and Communications, Kyoto, Japan.
⁴ Laboratory of Biostatistics, Clinical Research Center, NHO Nagoya Medical Center, Nagoya, Japan.
⁵ Department of Medical Oncology, St. Luke's International Hospital, Tokyo, Japan.
⁶ Department of Pediatrics, NHO Nagoya Medical Center, Nagoya, Japan.
⁷ Department of Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.
⁸ Department of Hematology, Osaka International Cancer Institute, Osaka, Japan.
⁹ Department of Palliative Medicine, Teikyo University School of Medicine, Tokyo, Japan.
¹⁰ Department of Psychiatry and Neurosciences, Graduate School of Biomedical Sciences, Hiroshima University, Hiroshima, Japan.
¹¹ Division of Neuropsychiatry, Department of Neuroscience, Yamaguchi University Graduate School of Medicine, Ube, Japan.
¹² Cancer Solutions Co., Ltd., Tokyo, Japan.
¹³ Department of Cancer Survivorship and Digital Medicine, the Jikei University School of Medicine, Tokyo, Japan.
¹⁴ Division of Survivorship Research, National Cancer Center Institute for Cancer Control, Tokyo, Japan.

PMID: 39193645
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.

Abstract

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