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

Distress, Emotional Clinical Trial

— DIBHApp  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05791084
• Other study ID #: 2021-04031
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: March 30, 2029

Study information

• Verified date: March 2023
• Source: Jonkoping University
• Contact: maria Brovall, ass prof
• Phone: +46705501097
• Email: maria.brovall[@]ju.se
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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)?

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: March 30, 2029
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.
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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jonkoping University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Logged data from the CT machine	number of correct and failed breathing attempts that the patient needs for approved CT. (nr of CT)	at Ct planning visit, one week
Other	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
Other	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
Other	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
Other	Logged data from the CT machine	number of CT images,	3 weeks post RT
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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