Supporting Women With Breast Cancer to Practice DIBH at Home Before Radiation Therapy
NCT ID: NCT05791084
Last Updated: 2023-03-30
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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NOT_YET_RECRUITING
NA
160 participants
INTERVENTIONAL
2023-09-01
2029-03-30
Brief Summary
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Detailed Description
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* 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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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A=Control group who receives customary information prior to RT with DIBH.
Usual care and information before start of radiotherapy with DIBH.
No interventions assigned to this group
B=Intervention group usual care and the DIBH-App to practice at-home before RT with DIBH.
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.
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
FEMALE
No
Sponsors
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Jonkoping University
OTHER
Responsible Party
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Maria Brovall
associated professor
Principal Investigators
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maria Brovall, ass prof
Role: PRINCIPAL_INVESTIGATOR
Jonkoping University
Central Contacts
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Other Identifiers
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2021-04031
Identifier Type: -
Identifier Source: org_study_id
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