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NCT Number: NCT05791084

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

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.

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Key information

Conditions

Health Literacy Distress, Emotional Mobile Application Preparedness

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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)?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

  1. Distress (DIS-A)

    Time frame: Time 1, baseline at randomisation/inclusion

    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.

  2. Distress (DIS-A)

    Time frame: time 2, at CT-planning visit one week

    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.

  3. Distress (DIS-A)

    Time frame: time 3, 3 weeks post RT

    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.

  4. Distress (DIS-A)

    Time frame: time 4, 6 month post RT

    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.

  5. Distress (DIS-A)

    Time frame: time 5, 5 years after RT

    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.

Secondary outcomes

  1. HRQoL and Health economic (EQ-5D-5L)

    Time frame: at baseline when inclusion/randomisation

    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.

  2. HRQoL and Health economic (EQ-5D-5L)

    Time frame: 5 years post RT

    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.

  3. e-HL (eHLQ)

    Time frame: at baseline when inclusion/randomisation

    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.

  4. Communicative, critical and functional HL

    Time frame: at baseline when inclusion/randomisation

    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).

  5. Preparedness(PCSQ-24)

    Time frame: at CT planning visit, one week

    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)

  6. The Radiotherapy Experience Questionnaire, Swedish modified version

    Time frame: 3 weeks post RT

    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

Other outcomes

  1. Logged data from the CT machine

    Time frame: at Ct planning visit, one week

    will be collected at all treatment occasions on all included patients. Estimation of time for planning CT (min)

  2. Logged data from the CT machine

    Time frame: at Ct planning visit, one week

    number of correct and failed breathing attempts that the patient needs for approved CT. (nr of CT)

  3. Data from the journal

    Time frame: at Ct planning visit, one week

    Data from the journal on all included patients, looking at extra visits for making planning CT.

  4. Logged data from the RT machine

    Time frame: at Ct planning visit, one week

    Logged data from radiation treatment devices (linear accelerators) will be collected at all treatment occasions on all included patients. Estimation of time on RT

  5. Logged data from the CT machine

    Time frame: 3 weeks post RT

    will be collected at all treatment occasions on all included patients. Estimation of time on planning CT (min)

  6. Logged data from the CT machine

    Time frame: 3 weeks post RT

    number of CT images,

  7. Logged data from the journal

    Time frame: 3 weeks post RT

    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.

  8. Logged data from RT machine

    Time frame: 3 weeks post RT

    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.

  9. Measurement of chest mobility

    Time frame: at baseline when inclusion/randomisation

    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)

  10. Measurement of chest mobility

    Time frame: at planning CT, one week

    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)

  11. RMMI test

    Time frame: at planning CT visit, one week

    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.

  12. Planned and given absorbed RT dose to the heart during RT

    Time frame: baseline at inclusion /randomisation

    Given and planned RT-heart dose will be obtained from the journal. Note possibly heart or lung diseases

  13. Planned and given absorbed RT dose to the heart during RT

    Time frame: 5 years post RT

    Given and planned RT-heart dose will be obtained from the journal, 5 years after RT. Note possibly heart or lung diseases

  14. Demographic information. Modified version of The self-administrated comorbidity, The Self-Administered Comorbidity

    Time frame: baseline at inclusion/randomisation

    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.

  15. Demographic information, Modified version of The self-administrated comorbidities, The Self-Administered Comorbidity

    Time frame: 5 years follow up post RT

    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.

  16. Training patterns

    Time frame: from baseline at inclusion/randomisation

    Number of times practiced and maximal movement at each training session (min vs max). Logged data from app.

  17. Training patterns

    Time frame: up until the CT planning vistit, one week

    Number of times practiced and maximal movement at each training session (min vs max). Logged data from app.

  18. Environmental effects

    Time frame: 3 weeks post RT

    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).

  19. Focus group interview

    Time frame: 3 weeks post RT

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

maria Brovall, ass prof

CONTACT

[email protected]

+46705501097

Sponsors and collaborators

Lead sponsor

Jonkoping University

Other

Registry information

Official study title

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

Acronym: DIBHApp

Important dates

Study start
2023
Primary completion
2024
Study completion
2029
First posted
Mar 30, 2023
Registry last updated
Mar 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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