Digi-Do - a Digital Information Tool to Help Patients Diagnosed With Breast Cancer
NCT ID: NCT04394325
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2020-09-01
2023-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Group A) Intervention group
Group A) an intervention group (n=80) who will receive the standard care and information (oral and written) + the digital information tool.
Digital information tool
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.
Group B) Control group
Group B) a control group (n=80) who will receive standard care and information (oral and written).
No interventions assigned to this group
Interventions
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Digital information tool
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* diagnosed with dementia
18 Years
ALL
No
Sponsors
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Jonkoping University
OTHER
Responsible Party
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Maria Brovall
Associate Professor
Principal Investigators
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maria brovall
Role: PRINCIPAL_INVESTIGATOR
Jonkoping Univeristy Box 1026, 551 11 Jonkoping
Locations
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Sahlgrenska universitetssjukhuset
Gothenburg, , Sweden
Countries
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References
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Fristedt S, Smith F, Grynne A, Browall M. Digi-Do: a digital information tool to support patients with breast cancer before, during, and after start of radiotherapy treatment: an RCT study protocol. BMC Med Inform Decis Mak. 2021 Feb 25;21(1):76. doi: 10.1186/s12911-021-01448-3.
Other Identifiers
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JU 2020/1732-51
Identifier Type: -
Identifier Source: org_study_id