Dataset Information

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.

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.

SUBMITTER: Akechi T

PROVIDER: S-EPMC6231603 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature

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Publications

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.

Akechi Tatsuo T Yamaguchi Takuhiro T Uchida Megumi M Imai Fuminobu F Momino Kanae K Katsuki Fujika F Sakurai Naomi N Miyaji Tempei T Horikoshi Masaru M Furukawa Toshi A TA Iwata Hiroji H Uchitomi Yosuke Y

BMJ open 20181108 11

<h4>Introduction</h4>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 smar ...[more]

PMID: 30413519

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Project description:In this paper we argue that a synthesis of findings across the various sub-areas of research in complex problem solving and consequently progress in theory building is hampered by an insufficient differentiation of complexity and difficulty. In the proposed framework of person, task, and situation (PTS), complexity is conceptualized as a quality that is determined by the cognitive demands that the characteristics of the task and the situation impose. Difficulty represents the quantifiable level of a person's success in dealing with such demands. We use the well-documented "semantic effect" as an exemplar for testing some of the conceptual assumptions derived from the PTS framework. We demonstrate how a differentiation between complexity and difficulty can help take beyond a potentially too narrowly defined psychometric perspective and subsequently gain a better understanding of the cognitive mechanisms behind this effect. In an empirical study a total of 240 university students were randomly allocated to one of four conditions. The four conditions resulted from contrasting the semanticity level of the variable labels used in the CPS system (high vs. low) and two instruction conditions for how to explore the CPS system's causal structure (starting with the assumption that all relationships between variables existed vs. starting with the assumption that none of the relationships existed). The variation in the instruction aimed at inducing knowledge acquisition processes of either (1) systematic elimination of presumptions, or (2) systematic compilation of a mental representation of the causal structure underpinning the system. Results indicate that (a) it is more complex to adopt a "blank slate" perspective under high semanticity as it requires processes of inhibiting prior assumptions, and (b) it seems more difficult to employ a systematic heuristic when testing against presumptions. In combination, situational characteristics, such as the semanticity of variable labels, have the potential to trigger qualitatively different tasks. Failing to differentiate between 'task' and 'situation' as independent sources of complexity and treating complexity and difficulty synonymously threaten the validity of performance scores obtained in CPS research.

Dataset Information

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.

Introduction

Methods and analysis

Ethics and dissemination

Trial status

Trial registration number

Publications

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.

Similar Datasets

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