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  • Smartphone problem-solving and behavioural activation therapy to reduce fear of recurrence among patients with breast cancer (SMartphone Intervention to LEssen fear of cancer recurrence: SMILE project): protocol for a randomised controlled trial

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Mental health
Protocol
Smartphone problem-solving and behavioural activation therapy to reduce fear of recurrence among patients with breast cancer (SMartphone Intervention to LEssen fear of cancer recurrence: SMILE project): protocol for a randomised controlled trial
  1. Tatsuo Akechi1,2,
  2. Takuhiro Yamaguchi3,
  3. Megumi Uchida1,2,
  4. Fuminobu Imai1,2,
  5. Kanae Momino4,
  6. Fujika Katsuki5,
  7. Naomi Sakurai6,
  8. Tempei Miyaji7,
  9. Masaru Horikoshi8,
  10. Toshi A Furukawa9,
  11. Hiroji Iwata10,
  12. Yosuke Uchitomi11
  1. 1 Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan
  2. 2 Division of Palliative Care and Psycho-oncology, Nagoya City University Hospital, Nagoya, Japan
  3. 3 Division of Biostatistics, Tohoku University Graduate School of Medicine, Sendai, Japan
  4. 4 Department of Nursing Administration and Management, Nagoya City University School of Nursing, Nagoya, Japan
  5. 5 Department of Psychiatric and Mental Health Nursing, Nagoya City University School of Nursing, Nagoya, Japan
  6. 6 Cancer Solutions, Tokyo, Japan
  7. 7 Department of Clinical Trial Data Management, Tokyo University Graduate School of Medicine, Tokyo, Japan
  8. 8 National Center for Cognitive Behavior Therapy and Research, National Center of Neurology and Psychiatry, Tokyo, Japan
  9. 9 Department of Health Promotion of Human Behavior, Graduate School of Medicine and School of Public Health, Kyoto University, Kyoto, Japan
  10. 10 Department of Breast Oncology, Aichi Cancer Center Hospital, Nagoya, Japan
  11. 11 Behavioral and Survivorship Research Group, Innovation Center for Supportive, Palliative and Psychosocial Care, National Cancer Center Hospital, Center for Public Health Sciences, National Cancer Center, Tokyo, Japan
  1. Correspondence to Dr Tatsuo Akechi; takechi{at}med.nagoya-cu.ac.jp

Abstract

Introduction One of the most common distressing conditions experienced by breast cancer survivors is fear of cancer recurrence (FCR). There is, however, no standard intervention for ameliorating FCR. Our clinical experience and previous studies have suggested the potential benefits of problem-solving therapy (PST) and behavioural activation (BA). Given the huge number of cancer survivors and limited number of therapists to competently conduct PST and BA, we have developed PST and BA smartphone applications. This study aimed to evaluate the efficacy of the smartphone-based PST (Kaiketsu-App) and BA (Genki-App) apps in reducing FCR in patients with breast cancer.

Methods and analysis The SMartphone Intervention to LEssen fear of cancer recurrence project is an open-label, individually randomised, parallel-group trial. Allocation will be managed by a central server using a computer-generated random allocation sequence provided by an independent data centre. Participants will be randomised to smartphone-based intervention plus treatment as usual (TAU) or waitlist control with TAU alone. The primary endpoint of the study is the Japanese version of the Concerns About Recurrence Scale, which will be administered as an electronic patient-reported outcome on the patients’ smartphone after 8 weeks.

Ethics and dissemination The present study is subject to the ethical guidelines for clinical studies published by Japan’s Ministry of Education, Science and Technology and Ministry of Health, Labour and Welfare and the modified Act on the Protection of Personal Information as well as the ethical principles established for research on humans stipulated in the Declaration of Helsinki and further amendments thereto. The protocol was approved by the Institutional Review Board of Nagoya City University on 15 January 2018 (ID: 60-00-1171).

Trial status The randomised trial, which commenced on 2 April 2018, currently enrols participants. The estimated end date for this study is in March 2020.

Trial registration number UMIN000031140; Pre-results.

  • neoplasma
  • fear of recurrence
  • cancer survivorship
  • psychosocial intervention
  • information and communication technology
  • quality of life

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2018-024794

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    Footnotes

    • Contributors TA, TAF and MH developed the smartphone applications and MU and FI also contributed to modification of these applications. TA, TY, KM, FK, NS, TM, TAF, HI and YU participated in the design of the study. TY played a chief role in the statistical parts. TA drafted the manuscript. All authors participated in, read and approved the final manuscript.

    • Funding This study is supported by a Grant-in-Aid for Japan Agency for Medical Research and Development (JP17ck0106324h). This study is supported in part by a Grant-in-Aid for Scientific Research (25285194) and Young Scientists (17k13942) from the Japanese Ministry of Education, Culture, Science and Technology, grant from Nagoya City University, Foundation for Promotion of Cancer Research in Japan and the National Cancer Center Research and Development Fund (27-A-3 and 30-A-11).

    • Competing interests TA has received lecture fees from AstraZeneca, Daiichi-Sankyo, Dainippon-Sumitomo, Eizai, Hisamitsu, Lilly, MSD, Meiji-seika Pharma, Mochida, Pfizer, Novartis, Otsuka, Shionogi, Takeda, Tanabe-Mitsubishi, Terumo and Yoshitomi. TA has received research funds from Daiichi-Sankyo, Eizai, MSD, Pfizer, Novartis and Tanabe-Mitsubishi. TY received research funds from AC MEDICAL, A2 Healthcare, CAC Croit, FMD K&L Japan, Japan Tobacco, Japan Media, Luminary Medical, Medidata Solutions, ONO PHARMACEUTICAL, Kyowa Hakko Kirin and DAIICHI SANKYO. TY received consulting fees from ONO PHARMACEUTICAL, Kowa, Japan Tobacco, CHUGAI PHARMACEUTICAL, TSUMURA & CO, CAC Croit, ASAHI INTECC, Asahi Kasei Pharma and Clinical Trial. FK has received lecture fees from MSD. TAF has received lecture fees from Janssen, Meiji, Mitsubishi-Tanabe, MSD and Pfizer. He has received research support from Mitsubishi-Tanabe. HI has received lecture fees from Daiichi Sankyo, Chugai, AstraZeneca, Pfizer and Eisai. He has received research support from Daiichi Sankyo, Chugai, AstraZeneca, Pfizer, MSD, Kyowahakou Kirin, GSK, Lilly, Novartis and Bayer. YU has received lectures fees from Asteras, Daiichi-Sankyo, Dainippon-Sumitomo, Eizai, Jannsen, Kyowahakko-Kirin, Ono, Meiji-seika Pharma, Mochida, Pfizer, Novartis, Otsuka, Sawai, Shionogi, Taiho, Tanabe-Mitsubishi and Tsumura Pharma.

    • Patient consent Not required.

    • Ethics approval The protocol was approved by the Institutional Review Board of Nagoya City University on 15 January 2018 (ID: 60-00-1171).

    • Provenance and peer review Not commissioned; externally peer reviewed.