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Published in: BMC Medical Informatics and Decision Making 1/2021

01-12-2021 | Breast Cancer | Study protocol

Digi-Do: a digital information tool to support patients with breast cancer before, during, and after start of radiotherapy treatment: an RCT study protocol

Authors: Sofi Fristedt, Frida Smith, Annika Grynne, Maria Browall

Published in: BMC Medical Informatics and Decision Making | Issue 1/2021

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Abstract

Background

Radiation Therapy (RT) is a common treatment after breast cancer surgery and a complex process using high energy X-rays to eradicate cancer cells, important in reducing the risk of local recurrence. The high-tech environment and unfamiliar nature of RT can affect the patient’s experience of the treatment. Misconceptions or lack of knowledge about RT processes can increase levels of anxiety and enhance feelings of being unprepared at the beginning of treatment. Moreover, the waiting time is often quite long. The primary aim of this study will be to evaluate whether a digital information tool with VR-technology and preparatory information can decrease distress as well as enhance the self-efficacy and health literacy of patients affected by breast cancer before, during, and after RT. A secondary aim will be to explore whether the digital information tool increase patient flow while maintaining or increasing the quality of care.

Method

The study is a prospective and longitudinal RCT study with an Action Research participatory design approach including mixed-methods data collection, i.e., standardised instruments, qualitative interviews (face-to-face and telephone) with a phenomenological hermeneutical approach, diaries, observations, and time measurements, and scheduled to take place from autumn 2020 to spring 2022. The intervention group (n = 80), will receive standard care and information (oral and written) and the digital information tool; and the control group (n = 80), will receive standard care and information (oral and written). Study recruitment and randomisation will be completed at two centres in the west of Sweden.

Discussion

Research in this area is scarce and, to our knowledge, only few previous studies examine VR as a tool for increasing preparedness for patients with breast cancer about to undergo RT that also includes follow-ups six months after completed treatment. The participatory approach and design will safeguard the possibilities to capture the patient perspective throughout the development process, and the RCT design supports high research quality. Digitalisation brings new possibilities to provide safe, person-centred information that also displays a realistic picture of RT treatment and its contexts. The planned study will generate generalisable knowledge of relevance in similar health care contexts.
Trial registration: ClinicalTrials.gov Identifier: NCT04394325. Registered May 19, 2020. Prospectively registered.
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Metadata
Title
Digi-Do: a digital information tool to support patients with breast cancer before, during, and after start of radiotherapy treatment: an RCT study protocol
Authors
Sofi Fristedt
Frida Smith
Annika Grynne
Maria Browall
Publication date
01-12-2021
Publisher
BioMed Central
Published in
BMC Medical Informatics and Decision Making / Issue 1/2021
Electronic ISSN: 1472-6947
DOI
https://doi.org/10.1186/s12911-021-01448-3

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