Breast CancerNCT04394325
Digi-Do - a Digital Information Tool to Help Patients Diagnosed With Breast Cancer
A study testing Digital information tool in people with Breast Cancer, run by Jonkoping University at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Digital information tool
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2020to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- not receiving RT have had RT before
- diagnosed with dementia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Breast Cancer
- Being tested
- Digital information tool
- Keywords
- Digital Technology, Radiotherapy (RT), Patient information, Virtual Reality (VR)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital information toolBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A) Intervention group | Experimental | Group A) an intervention group (n=80) who will receive the standard care and information (oral and written) + the digital information tool. Receives: Behavioral: Digital information tool |
| Group B) Control group | No intervention | Group B) a control group (n=80) who will receive standard care and information (oral and written). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in distress
The National Comprehensive Cancer Network Distress Thermometer is a brief screening tool for cancer patients to assess psychosocial distress
Measured: 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
Measured: 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
Measured: 6 months after the intervention
Secondary outcomes (10)
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'').
Measured: 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'').
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: up to five week of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start1 Sep 2020
- Primary completion1 Jun 2022
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonkoping University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Brovall, Jonkoping University
- Investigators
- maria brovall, Principal investigator, Jonkoping Univeristy Box 1026, 551 11 Jonkoping
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04394325
- Sponsor's protocol ID
- JU 2020/1732-51
- Status last verified
- Dec 2025
- First submitted
- 6 May 2020
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33632215
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04394325
- Acronym / sponsor ID
- JU 2020/1732-51
- Conditions
- Breast Cancer
- Keywords
- Digital Technology, Radiotherapy (RT), Patient information, Virtual Reality (VR)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Jonkoping UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 19 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A) Intervention group | Experimental | Behavioral: Digital information toolGroup A) an intervention group (n=80) who will receive the standard care and information (oral and written) + the digital information tool. |
| Group B) Control group | No intervention | –Group B) a control group (n=80) who will receive standard care and information (oral and written). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- not receiving RT have had RT before
- diagnosed with dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital information toolThe 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. | Behavioural | Group A) Intervention group |
Primary outcome
Change in distress
Time frame: Baseline pre intervention
The National Comprehensive Cancer Network Distress Thermometer is a brief screening tool for cancer patients to assess psychosocial distress
Change in distress
Time frame: up to one week of intervention
The National Comprehensive Cancer Network Distress Thermometer is a brief screening tool for cancer patients to assess psychosocial distress
Change in distress
Time frame: 6 months after the intervention
The National Comprehensive Cancer Network Distress Thermometer is a brief screening tool for cancer patients to assess psychosocial distress
10 secondary outcomes
Change in general self-efficacy
Time frame: Baseline pre intervention
Change in general self-efficacy
Time frame: 6 months after the intervention
Change in communicative and critical health literacy
Time frame: Baseline pre intervention
Change in communicative and critical health literacy
Time frame: 6 months after the intervention
Change in functional health literacy
Time frame: Baseline pre intervention
Change in functional health literacy
Time frame: 6 months after the intervention
Change in eHealth literacy
Time frame: Baseline pre intervention
Change in eHealth literacy
Time frame: 6 months after the intervention
Time measurements and Observations
Time frame: up to one week of intervention
Time measurements and Observations
Time frame: up to five week of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Derived from this study: PubMed 33632215Fristedt 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
maria brovall principal investigator
Jonkoping Univeristy Box 1026, 551 11 Jonkoping
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital information tool in people with Breast Cancer, run by Jonkoping University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in distress (time frame: Baseline pre intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04394325, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.