Digi-Do - a Digital Information Tool to Help Patients Diagnosed With Breast Cancer

Study Overview
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Brief Summary
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This project uses participatory design combined with qualitative and quantitative methods to develop, explore and evaluate the usefulness of a digital information tool to prepare and support patients before, during and after RT as treatment for breast cancer.

Detailed Description
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The study is a prospective and longitudinal Randomised Control Trial (RCT) study with an Action Research (AR) participatory design approach, including mixed-method data collection, i.e., standardised instruments, interviews (face-to-face and telephone), diaries, observation, and time measurements. The timeline for the study is scheduled between autumn 2020 to spring 2022. The study will consist of two arms: A) an intervention group (n=80), who will receive standard care and information and the digital information tool; and B) a control group (n=80) who will receive standard care and information (verbal and written). Recruitment and randomisation will be completed at two hospitals in the South western part of Sweden. As a pre-phase, a pilot study was performed for the development and testing of the digital information tool (Digi-Do), approved by the Regional Ethics Committee (Dnr 917-17) with 30 patients in total (15 women with breast cancer and 15 men with prostate cancer). According to the study's co-design, iterative methodology [26-27 in manuscript], changes have since been made to the digital information tool and a second version has now been developed for the full RCT. The present study has been approved by the Swedish Ethical Review Authority (Dnr 2020-00170). An ongoing systematic literature review will also guide the present study, and the project is registered in PROSPERO (PROSPERO;168073). The digital information tool applied in this project is divided into two separate but coherent applications (apps) for mobile devices: one (VR-app) with a guided tour of the RT-department with a voice-over to describe 360 images to create a sense of actually having visited the department prior to start of RT, and one (information app) containing information obtained through the pre-treatment phase. If a VR-effect is not desirable, the patient can complete the simulated study-visit on their mobile phone or tablet as well as present the images in the browser of an integrated media player. Three areas of information are available in the information app: 1) Q&As from the existing written information, presented both in writing and a recorded voice; 2) practical information, such as maps, public transportation options with relevant links to public transport, telephone numbers, and information about possibilities for staying at the patient hotel; and 3) three short animated films about cancer and physical activity during RT.

Official Title
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Digi-Do - a Digital Information Tool to Help Patients Diagnosed With Breast Cancer to be Involved and Prepared Before, During, and After Start of Radiotherapy Treatment

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: Digital information tool


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients (>18 years): diagnosed with breast cancer, stage I-II not receiving adjuvant or neo-adjuvant chemotherapy or anti-Her-2 treatment and with RT as additional treatment after surgery. ability to read, write and understand Swedish enough to adhere to the digital information tool and the applied instruments. that have access to a smartphone. Exclusion Criteria: not receiving RT have had RT before diagnosed with dementia

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A) Intervention group<br>Group A) an intervention group (n=80) who will receive the standard care and information (oral and written) + the digital information tool. | Behavioral: Digital information tool<br>* The patients randomized to group A will receive verbal and written information regarding the digital information tool and how to use it, as well as verbal and written information about the study. They will also receive information about the different instruments and surveys they will be asked to answer at different occasions during the RT treatment period. The applied instruments for data collection will be administrated in person or by post at the baseline collection and by post (including pre-paid return envelope) on consecutive collections. Approximately 30 patients (in group A) will be asked to make regular notes in a notebook during the waiting period prior start of RT as well as during RT treatment period. Following completion of the RT treatment period individual in-depth and telephone interviews will take place with 10-12 patients that accept participation.<br>|
| No Intervention: Group B) Control group<br>Group B) a control group (n=80) who will receive standard care and information (oral and written). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in distress | The National Comprehensive Cancer Network Distress Thermometer is a brief screening tool for cancer patients to assess psychosocial distress | Baseline pre intervention | 
| Change in distress | The National Comprehensive Cancer Network Distress Thermometer is a brief screening tool for cancer patients to assess psychosocial distress | up to one week of intervention | 
| Change in distress | The National Comprehensive Cancer Network Distress Thermometer is a brief screening tool for cancer patients to assess psychosocial distress | 6 months after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in general self-efficacy | The Swedish version of the General Self-efficacy (GSE) Scale. The GSE scale consists of 10 items rated on a fourpoint Likert scale (''not at all true'' to ''exactly true''). | Baseline pre intervention | 
| Change in general self-efficacy | The Swedish version of the General Self-efficacy (GSE) Scale. The GSE scale consists of 10 items rated on a fourpoint Likert scale (''not at all true'' to ''exactly true''). | 6 months after the intervention | 
| Change in communicative and critical health literacy | The communicative and critical health literacy scale - Swedish version. The first three items include statements focusing on the capacity for collecting, extracting, and understanding relevant health information. Each item is rated on a 4-point scale, ranging from 1 (never=better) to 4 (often=worse). | Baseline pre intervention | 
| Change in communicative and critical health literacy | The communicative and critical health literacy scale - Swedish version. The first three items include statements focusing on the capacity for collecting, extracting, and understanding relevant health information. Each item is rated on a 4-point scale, ranging from 1 (never=better) to 4 (often=worse). | 6 months after the intervention | 
| Change in functional health literacy | The Swedish Functional Health Literacy scale scale comprises five items about persons' skills in reading and understanding health information. Each item is rated on a 4-point scale, ranging from 1 (never=better) to 4 (often=worse). | Baseline pre intervention | 
| Change in functional health literacy | The Swedish Functional Health Literacy scale scale comprises five items about persons' skills in reading and understanding health information. Each item is rated on a 4-point scale, ranging from 1 (never=better) to 4 (often=worse). | 6 months after the intervention | 
| Change in eHealth literacy | The The eHealth Literacy Questionnaire (eHLQ) is a psychometrically robust multidimensional tool designed to be used to understand and evaluate people's interaction with digital health services | Baseline pre intervention | 
| Change in eHealth literacy | The The eHealth Literacy Questionnaire (eHLQ) is a psychometrically robust multidimensional tool designed to be used to understand and evaluate people's interaction with digital health services | 6 months after the intervention | 
| Time measurements and Observations | Ten patients respectively from groups A and B will be consequently asked to participate in the time measurement and observational part of the study (n=20). All planned treatments for the first week of RT (n=5), and, additionally, one session in the last week of treatment, will be measured based on seven timepoints; patient enters door of RT room, patient lies on table, first image, first field beam on, last field beam on, patient leaves table, and patient leaves RT room. This will result in approximately 120 points of measurement. During each RT session, observations of questions asked by patients and staff will be documented in a protocol, including what subjects are addressed, who initiates the question, and whether, how, and to where the staff refers the patient for further information. | up to one week of intervention | 
| Time measurements and Observations | Ten patients respectively from groups A and B will be consequently asked to participate in the time measurement and observational part of the study (n=20). All planned treatments for the first week of RT (n=5), and, additionally, one session in the last week of treatment, will be measured based on seven timepoints; patient enters door of RT room, patient lies on table, first image, first field beam on, last field beam on, patient leaves table, and patient leaves RT room. This will result in approximately 120 points of measurement. During each RT session, observations of questions asked by patients and staff will be documented in a protocol, including what subjects are addressed, who initiates the question, and whether, how, and to where the staff refers the patient for further information. | up to five week of intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Digital Technology, Radiotherapy (RT), Patient information, Virtual Reality (VR)