An interventional study of Digital information tool in Breast Cancer, sponsored by Jonkoping University. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-17.
Sponsored by Jonkoping University · Not applicable, Interventional, and Supportive care
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.
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 80 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Jonkoping University is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients (>18 years):
Exclusion Criteria:
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
Group B) a control group (n=80) who will receive standard care and information (oral and written).
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.
Change in distress
The National Comprehensive Cancer Network Distress Thermometer is a brief screening tool for cancer patients to assess psychosocial distress
Time frame: 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
Time frame: 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
Time frame: 6 months after the 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'').
Time frame: 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'').
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: up to five week of intervention
In-depth interviews
The individual in-depth and/or telephone interviews will take place on two occasions (1-4 weeks and 6 months post-RT completion) and with at least ten of the patients who have accepted participation and have made regular notes. Questions will include topics such as their experiences of receiving the information through the digital information tool during the waiting time and treatment period, of using the digital information tool, to what extent the digital information has affected their involvement and preparedness for the radiation treatment, as well as their experiences during the time since the end of RT
Time frame: 1 week after the intervention
In-depth interviews
The individual in-depth and/or telephone interviews will take place on two occasions (1-4 weeks and 6 months post-RT completion) and with at least ten of the patients who have accepted participation and have made regular notes. Questions will include topics such as their experiences of receiving the information through the digital information tool during the waiting time and treatment period, of using the digital information tool, to what extent the digital information has affected their involvement and preparedness for the radiation treatment, as well as their experiences during the time since the end of RT
Time frame: 6 months after the intervention
Plan to share: No
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