Health LiteracyDIBHAppNCT05791084
Supporting Women With Breast Cancer to Practice DIBH at Home Before Radiation Therapy
A study testing mobile application with breathing instructions and a sensor to attach around the chest. To be able to train at home before radiotherapy with DIBH starts. in people with Health Literacy and Distress, Emotional, run by Jonkoping University.
Trial summary
To examine the effect of a preparatory digital tool including a new instruction for deep inspiration breath hold (DIBH), before start of radiation therapy in women diagnosed with left sided breast cancer, compared with usual care. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Health Literacy, Distress, Emotional, Preparedness
- What is being tested?
- mobile application with breathing instructions and a sensor to attach around the chest. To be able to train at home before radiotherapy with DIBH starts.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 30 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients > 18 years of age
- with a left-sided breast cancer diagnosis or DCIS
- who are to receive RT with DIBH technology
- with curative intention
- preparatory CT visit minimum 7 days to a maximum of 4 weeks
- able to speak and understand good enough Swedish to be able to assimilate content in the mobile app and answer surveys and interview questions
- have access to a smart mobile phone.
Who cannot join
- patients receiving palliative RT or neoadjuvant chemotherap
- Planning CT starting < 7 days
- people with some form of orthopedic, rheumatological or neurological injury or disease that limits the possibility of carrying out the intervention.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Supporting Women With Left Sided Breast Cancer to Practice Deep Inspiration Breath Hold (DIBH) at Home Before Radiation Therapy Treatment
To examine the effect of a preparatory digital tool including a new instruction for deep inspiration breath hold (DIBH), before start of radiation therapy in women diagnosed with left sided breast cancer, compared with usual care.
Read the detailed description
The following questions will be posted:
- Are there any differences in levels of distress (primary outcome) between the control and intervention group at baseline and over time?
- Are there any differences in preparedness for RT (secondary outcomes) between the control and intervention group at baseline and over time?
- Are there any correlations between Health Literacy (HL) levels (secondary outcome) and levels of distress (primary outcome) in the control and intervention group?
- Are there any differences in objective clinical variables (chest mobility and respiratory movements and planned absorbed dose to the heart) between the control and intervention group before and after the intervention (baseline and at planning CT)?
- Which patterns of practice and use of the application (when, how, how often and for how long) can be discerned from the intervention group?
- Are there any correlations between different levels of practice and use of the digital tool and primary and secondary outcomes?
- How do patients in the different groups (control and intervention group) describe their experience of care and information process during RT with DIBH?
- Are there differences regarding health economic variables in terms of costs and health care usage (e.g., estimated time for planning and conducting computed tomography (CT), number of scheduled CT examinations) and patient effects (e.g. co-morbidities (heart related), sick leave, and quality-adjusted life year (QALYs) between patients in control- or interventions group?
- Are there any differences regarding effects on environmental aspects and costs in the different groups (control and intervention)?
- Conditions
- Health Literacy, Distress, Emotional, Preparedness, Mobile Application
- Being tested
- mobile application with breathing instructions and a sensor to attach around the chest. To be able to train at home before radiotherapy with DIBH starts.
- Keywords
- DIBH, RCT, radiotherapy, mobile application, distress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mobile application with breathing instructions and a sensor to attach around the chest. To be able to train at home before radiotherapy with DIBH starts.Other
The DIBH-App consists of 1) a mobile application that patients download to their own smart mobile phone, and 2) associated stretch-sensors that are attached around the chest and connected to the mobile phone via Bluetooth. Visually, the graphics is similar to the software used for DIBH in the RT department. Coaching takes place through instructional videos, text, and audio recordings (Image 2). The following information will be recorded and stored: date and time of practice, outcome of each session (including sensor data and calibration parameters), and user behavior within the application (such as screen visits, FAQ sections viewed, and key button presses).
| Study group | Role | What they receive |
|---|---|---|
| A=Control group who receives customary information prior to RT with DIBH. | No intervention | Usual care and information before start of radiotherapy with DIBH. |
| B=Intervention group usual care and the DIBH-App to practice at-home before RT with DIBH. | Experimental | Usual care and information and a mobile application with breathing instructions and a sensor to attach around the chest. To be able to train at home before radiotherapy with DIBH starts. Receives: Other: mobile application with breathing instructions and a sensor to attach around the chest. To be able to train at home before radiotherapy with DIBH starts. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distress (DIS-A)
The Distress Thermometer (DT) was developed as a simple tool to effectively screen for symptoms of distress. The instrument is a self-reported tool using a 0-to-10 rating scale, where 0 is no distress and 10 the worst distress.
Measured: Time 1, baseline at randomisation/inclusion
Distress (DIS-A)
The Distress Thermometer (DT) was developed as a simple tool to effectively screen for symptoms of distress. The instrument is a self-reported tool using a 0-to-10 rating scale, where 0 is no distress and 10 the worst distress.
Measured: time 2, at CT-planning visit one week
Distress (DIS-A)
The Distress Thermometer (DT) was developed as a simple tool to effectively screen for symptoms of distress. The instrument is a self-reported tool using a 0-to-10 rating scale, where 0 is no distress and 10 the worst distress.
Measured: time 3, 3 weeks post RT
Distress (DIS-A)
The Distress Thermometer (DT) was developed as a simple tool to effectively screen for symptoms of distress. The instrument is a self-reported tool using a 0-to-10 rating scale, where 0 is no distress and 10 the worst distress.
Measured: time 4, 6 month post RT
Distress (DIS-A)
The Distress Thermometer (DT) was developed as a simple tool to effectively screen for symptoms of distress. The instrument is a self-reported tool using a 0-to-10 rating scale, where 0 is no distress and 10 the worst distress.
Measured: time 5, 5 years after RT
Secondary outcomes (6)
HRQoL and Health economic (EQ-5D-5L)
Health economic measured with EQ-5D-5L a health-related quality of life instrument used to calculate quality-adjusted life years (QALY) . Its design accounts for the need for a direct link between the measurement and valuation of health, whereby every health state that patients might report on the EQ-5D-5L instrument can be summarised by a single value. In order to be used in the calculation of quality-adjusted life years (QALYs; a metric used in cost-utility anal-ysis that combines survival and HRQL), these values need to summarise how good or bad each health state is on a scale anchored at 1 (full health) and 0 (a state equivalent to dead). Values less than 0 represent health states considered to be or modelled as worse than dead.
Measured: at baseline when inclusion/randomisation
HRQoL and Health economic (EQ-5D-5L)
Health economic measured with EQ-5D-5L a health-related quality of life instrument used to calculate quality-adjusted life years (QALY) . Its design accounts for the need for a direct link between the measurement and valuation of health, whereby every health state that patients might report on the EQ-5D-5L instrument can be summarised by a single value. In order to be used in the calculation of quality-adjusted life years (QALYs; a metric used in cost-utility anal-ysis that combines survival and HRQL), these values need to summarise how good or bad each health state is on a scale anchored at 1 (full health) and 0 (a state equivalent to dead). Values less than 0 represent health states considered to be or modelled as worse than dead.
Measured: 5 years post RT
e-HL (eHLQ)
eHealth Literacy Questionnaire-Swedish version, aims to measure a broad range of literacy skills, which could make it useful in assessing the effects of strategies for delivering online information and applications. eHEALS is an 8-item instrument with each item scored on a 5-point Likert scale.Each item is rated on a 5-point. Likert scale, ranging from 1 = strongly disagree to 5 = strongly agree.
Measured: at baseline when inclusion/randomisation
Communicative, critical and functional HL
consists of 14 statements with 4 points Likert scales (1-4). The statements ask how often (never to often) patients have trouble with reading or understanding leaflets from healthcare providers/hospital or pharmacy (functional health literacy; 5 items), have difficulty (easy to rather difficult) performing certain actions in relation to health information (communicative (5 items) and critical (4 items) health literacy).
Measured: at baseline when inclusion/randomisation
Preparedness(PCSQ-24)
Modified version of the Preparedness for Colorectal Cancer Surgery Questionnaire, with 28 items measuring preparedness for surgery was developed covering four domains.All items were rated on a Likert-type scale with the following translated response options: Strongly agree, Agree somewhat, Disagree somewhat, and Totally disagree (with corresponding values ranging from 4 to 1)
Measured: at CT planning visit, one week
The Radiotherapy Experience Questionnaire, Swedish modified version
The Radiotherapy Experience Questionnaire (RTEQ) with 23 items. This instrument assesses the patient's experiences of the external RT procedure and includes psychological stress, physical discomfort and coping during the external RT procedure.t Likert-type scale for response options, which ranged from 1 = I strongly agree to 6 = I strongly disagree
Measured: 3 weeks post RT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start1 Sep 2023 (estimated)
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health LiteracyStudies 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
- Model description
- RCT with an intervention and control group
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jonkoping University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Brovall, Jonkoping University
- Investigators
- maria Brovall, ass prof, Principal investigator, Jonkoping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05791084
- Sponsor's protocol ID
- 2021-04031
- Acronym
- DIBHApp
- Status last verified
- Mar 2023
- First submitted
- 22 Feb 2023
- Last updated
- 30 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting Women With Left Sided Breast Cancer to Practice Deep Inspiration Breath Hold (DIBH) at Home Before Radiation Therapy Treatment
- ClinicalTrials.gov ID
- NCT05791084
- Acronym / sponsor ID
- DIBHApp / 2021-04031
- Conditions
- Health Literacy, Distress, Emotional, Preparedness, Mobile Application
- Keywords
- DIBH, RCT, radiotherapy, mobile application, distress
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Jonkoping UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Mar 2029 (estimated)
- First posted
- 30 Mar 2023 (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.
To examine the effect of a preparatory digital tool including a new instruction for deep inspiration breath hold (DIBH), before start of radiation therapy in women diagnosed with left sided breast cancer, compared with usual care.
Detailed description
The following questions will be posted:
- Are there any differences in levels of distress (primary outcome) between the control and intervention group at baseline and over time?
- Are there any differences in preparedness for RT (secondary outcomes) between the control and intervention group at baseline and over time?
- Are there any correlations between Health Literacy (HL) levels (secondary outcome) and levels of distress (primary outcome) in the control and intervention group?
- Are there any differences in objective clinical variables (chest mobility and respiratory movements and planned absorbed dose to the heart) between the control and intervention group before and after the intervention (baseline and at planning CT)?
- Which patterns of practice and use of the application (when, how, how often and for how long) can be discerned from the intervention group?
- Are there any correlations between different levels of practice and use of the digital tool and primary and secondary outcomes?
- How do patients in the different groups (control and intervention group) describe their experience of care and information process during RT with DIBH?
- Are there differences regarding health economic variables in terms of costs and health care usage (e.g., estimated time for planning and conducting computed tomography (CT), number of scheduled CT examinations) and patient effects (e.g. co-morbidities (heart related), sick leave, and quality-adjusted life year (QALYs) between patients in control- or interventions group?
- Are there any differences regarding effects on environmental aspects and costs in the different groups (control and intervention)?
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- RCT with an intervention and control group
| Arm | Type | Receives |
|---|---|---|
| A=Control group who receives customary information prior to RT with DIBH. | No intervention | –Usual care and information before start of radiotherapy with DIBH. |
| B=Intervention group usual care and the DIBH-App to practice at-home before RT with DIBH. | Experimental | Other: mobile application with breathing instructions and a sensor to attach around the chest. To be able to train at home before radiotherapy with DIBH starts.Usual care and information and a mobile application with breathing instructions and a sensor to attach around the chest. To be able to train at home before radiotherapy with DIBH starts. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- patients > 18 years of age
- with a left-sided breast cancer diagnosis or DCIS
- who are to receive RT with DIBH technology
- with curative intention
- preparatory CT visit minimum 7 days to a maximum of 4 weeks
Key exclusion criteria (3 listed)
- patients receiving palliative RT or neoadjuvant chemotherap
- Planning CT starting < 7 days
- people with some form of orthopedic, rheumatological or neurological injury or disease that limits the possibility of carrying out the intervention.
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 |
|---|---|---|
| mobile application with breathing instructions and a sensor to attach around the chest. To be able to train at home before radiotherapy with DIBH starts.The DIBH-App consists of 1) a mobile application that patients download to their own smart mobile phone, and 2) associated stretch-sensors that are attached around the chest and connected to the mobile phone via Bluetooth. Visually, the graphics is similar to the software used for DIBH in the RT department. Coaching takes place through instructional videos, text, and audio recordings (Image 2). The following information will be recorded and stored: date and time of practice, outcome of each session (including sensor data and calibration parameters), and user behavior within the application (such as screen visits, FAQ sections viewed, and key button presses). | Other | B=Intervention group usual care and the DIBH-App to practice at-home before RT with DIBH. |
Primary outcome
Distress (DIS-A)
Time frame: Time 1, baseline at randomisation/inclusion
The Distress Thermometer (DT) was developed as a simple tool to effectively screen for symptoms of distress. The instrument is a self-reported tool using a 0-to-10 rating scale, where 0 is no distress and 10 the worst distress.
Distress (DIS-A)
Time frame: time 2, at CT-planning visit one week
The Distress Thermometer (DT) was developed as a simple tool to effectively screen for symptoms of distress. The instrument is a self-reported tool using a 0-to-10 rating scale, where 0 is no distress and 10 the worst distress.
Distress (DIS-A)
Time frame: time 3, 3 weeks post RT
The Distress Thermometer (DT) was developed as a simple tool to effectively screen for symptoms of distress. The instrument is a self-reported tool using a 0-to-10 rating scale, where 0 is no distress and 10 the worst distress.
Distress (DIS-A)
Time frame: time 4, 6 month post RT
The Distress Thermometer (DT) was developed as a simple tool to effectively screen for symptoms of distress. The instrument is a self-reported tool using a 0-to-10 rating scale, where 0 is no distress and 10 the worst distress.
Distress (DIS-A)
Time frame: time 5, 5 years after RT
The Distress Thermometer (DT) was developed as a simple tool to effectively screen for symptoms of distress. The instrument is a self-reported tool using a 0-to-10 rating scale, where 0 is no distress and 10 the worst distress.
6 secondary outcomes
HRQoL and Health economic (EQ-5D-5L)
Time frame: at baseline when inclusion/randomisation
HRQoL and Health economic (EQ-5D-5L)
Time frame: 5 years post RT
e-HL (eHLQ)
Time frame: at baseline when inclusion/randomisation
Communicative, critical and functional HL
Time frame: at baseline when inclusion/randomisation
Preparedness(PCSQ-24)
Time frame: at CT planning visit, one week
The Radiotherapy Experience Questionnaire, Swedish modified version
Time frame: 3 weeks post RT
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
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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.
maria Brovall, ass prof principal investigator
Jonkoping University
Questions about this trial
What is this clinical trial studying?
A study testing mobile application with breathing instructions and a sensor to attach around the chest. To be able to train at home before radiotherapy with DIBH starts. in people with Health Literacy and Distress, Emotional, run by Jonkoping University.
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 7 inclusion and 3 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: opening soon, as of the sponsor's last update on 30 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact maria Brovall, ass prof (+46705501097, maria.brovall@ju.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distress (DIS-A) (time frame: Time 1, baseline at randomisation/inclusion). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Mar 2023.