Supporting Women With Breast Cancer to Practice DIBH at Home Before Radiation Therapy

Study Overview
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Brief Summary
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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
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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)?

Official Title
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Supporting Women With Left Sided Breast Cancer to Practice Deep Inspiration Breath Hold (DIBH) at Home Before Radiation Therapy Treatment

Conditions
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Health Literacy, Distress, Emotional, Preparedness, Mobile Application

Intervention / Treatment
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* 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.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion criteria for the study: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: RCT with an intervention and control group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: A=Control group who receives customary information prior to RT with DIBH.<br>Usual care and information before start of radiotherapy with DIBH. | |
| Experimental: B=Intervention group usual care and the DIBH-App to practice at-home before RT with DIBH.<br>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. | 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.<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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. | 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. | 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. | 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. | time 5, 5 years after RT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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). | 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) | 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 | 3 weeks post RT | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DIBH, RCT, radiotherapy, mobile application, distress