Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
The following questions will be posted:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| 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 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Logged data from the CT machine | will be collected at all treatment occasions on all included patients. Estimation of time for planning CT (min) | at Ct planning visit, one week |
| Logged data from the CT machine |
Inclusion Criteria:
Inclusion criteria for the study:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| maria Brovall, ass prof | Contact | +46705501097 | maria.brovall@ju.se |
| Name | Affiliation | Role |
|---|---|---|
| maria Brovall, ass prof | Jonkoping University | Principal Investigator |
Not provided
Not provided
RCT with an intervention and control group
Not provided
Not provided
Not provided
Not provided
|
| 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 |
number of correct and failed breathing attempts that the patient needs for approved CT. (nr of CT)
| at Ct planning visit, one week |
| Data from the journal | Data from the journal on all included patients, looking at extra visits for making planning CT. | at Ct planning visit, one week |
| 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 | at Ct planning visit, one week |
| Logged data from the CT machine | will be collected at all treatment occasions on all included patients. Estimation of time on planning CT (min) | 3 weeks post RT |
| Logged data from the CT machine | number of CT images, | 3 weeks post RT |
| Logged data from the journal | Logged data from the journal will be collected on all treatment occasions on all included patients. and extra visits during the treatment period and after. | 3 weeks post RT |
| Logged data from RT machine | Logged data from the radiation treatment devices (linear accelerators) will be collected at all treatment occasions on all included patients. Estimation of time on RT on each occasion. | 3 weeks post RT |
| Measurement of chest mobility | Respiratory Objective Measurements. Thorax extension: chest mobility will be measured with a measuring tape, during maximum breathing movements, with the addition of voluntary movements of the chest (the measurement is in centimeters and millimeters) | at baseline when inclusion/randomisation |
| Measurement of chest mobility | Respiratory Objective Measurements. Thorax extension: chest mobility will be measured with a measuring tape, during maximum breathing movements, with the addition of voluntary movements of the chest(the measurement is in centimeters and millimeters) | at planning CT, one week |
| RMMI test | Respiratory movements will be measured on ten patients in the pilot-test, from group B with the Respiratory Movement Measuring Instrument (RMMI) (ReMo Inc. Keldnaholt, Reykjavik, Iceland). The measurement will be performed during maximum breathing movements and is measured bilaterally in the upper and lower part of the thorax and the abdomen. The measurement will be performed by a physiotherapist in the project. The test will evaluate if the measurement with logged data in the app and the respiratory objective measurements are reliable measurements. If not, this measurement will be done to patients in the group B in the RCT study to evaluate the effect. | at planning CT visit, one week |
| Planned and given absorbed RT dose to the heart during RT | Given and planned RT-heart dose will be obtained from the journal. Note possibly heart or lung diseases | baseline at inclusion /randomisation |
| Planned and given absorbed RT dose to the heart during RT | Given and planned RT-heart dose will be obtained from the journal, 5 years after RT. Note possibly heart or lung diseases | 5 years post RT |
| Demographic information. Modified version of The self-administrated comorbidity, The Self-Administered Comorbidity | Modified version of The Self-Administered Comorbidity. Journal data will be collected. Data will be collected regarding type and dose of chemotherapy for control of e.g., heart toxicity, other diseases, medications, sick-leave. | baseline at inclusion/randomisation |
| Demographic information, Modified version of The self-administrated comorbidities, The Self-Administered Comorbidity | Modified version of The Self-Administered Comorbidity. Journal data will be collected. Data will be collected regarding type and dose of chemotherapy for control of e.g., heart toxicity, other diseases, medications, sick-leave. | 5 years follow up post RT |
| Training patterns | Number of times practiced and maximal movement at each training session (min vs max). Logged data from app. | from baseline at inclusion/randomisation |
| Training patterns | Number of times practiced and maximal movement at each training session (min vs max). Logged data from app. | up until the CT planning vistit, one week |
| Environmental effects | Modes of travelling, distance to clinic (km) and time spent for RT treatment (min). Questions answered i kilometer per mile, time estimation,type of transportation (car, buss, etc). | 3 weeks post RT |
| Focus group interview | The focus group interviews are based on open-ended questions, and they will be asked to describe their experience of the care process in breath-adapted radiation therapy (before, during and after the treatment) and the breathing practice based on their group affiliation. Participants are selected within each group with a view to a spread of age, socio-demographic characteristics, and treatment approach. | 3 weeks post RT |