Supporting Women With Breast Cancer to Practice DIBH at Home Before Radiation Therapy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorJonkoping University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
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 interventionThe 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).
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: A=Control group who receives customary information prior to RT with DIBH.No intervention 0 interventions
Group B: B=Intervention group usual care and the DIBH-App to practice at-home before RT with DIBH.Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Time 1, baseline at randomisation/inclusion2
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.
Time frame
time 2, at CT-planning visit one week3
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.
Time frame
time 3, 3 weeks post RT4
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.
Time frame
time 4, 6 month post RTSecondary outcomes
1
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.
Time frame
at baseline when inclusion/randomisation2
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.
Time frame
5 years post RT3
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.
Time frame
at baseline when inclusion/randomisation4
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).
Time frame
at baseline when inclusion/randomisationOther outcomes
1
Logged data from the CT machine
will be collected at all treatment occasions on all included patients. Estimation of time for planning CT (min)
Time frame
at Ct planning visit, one week2
Logged data from the CT machine
number of correct and failed breathing attempts that the patient needs for approved CT. (nr of CT)
Time frame
at Ct planning visit, one week3
Data from the journal
Data from the journal on all included patients, looking at extra visits for making planning CT.
Time frame
at Ct planning visit, one week4
Logged data from the RT machine
Logged data from radiation treatment devices (linear accelerators) will be collected at all treatment occasions on all included patients. Estimation of time on RT
Time frame
at Ct planning visit, one weekLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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