Clinical trial NCT05791084: Supporting Women With Breast Cancer to Practice DIBH at Home Before Radiation Therapy
Official title: Supporting Women With Left Sided Breast Cancer to Practice Deep Inspiration Breath Hold (DIBH) at Home Before Radiation Therapy Treatment
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Health Literacy
Distress, Emotional
Preparedness
Mobile Application
Keywords: DIBH
RCT
radiotherapy
mobile application
distress
Lead sponsor: Jonkoping University
Sponsor class: OTHER
First posted: 2023-03-30
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT with an intervention and control group
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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)?

Eligibility criteria: 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.

Primary outcomes:
measure: Distress (DIS-A)
timeFrame: Time 1, baseline at randomisation/inclusion
measure: Distress (DIS-A)
timeFrame: time 2, at CT-planning visit one week
measure: Distress (DIS-A)
timeFrame: time 3, 3 weeks post RT
measure: Distress (DIS-A)
timeFrame: time 4, 6 month post RT
measure: Distress (DIS-A)
timeFrame: time 5, 5 years after RT
Secondary outcomes:
measure: HRQoL and Health economic (EQ-5D-5L)
timeFrame: at baseline when inclusion/randomisation
measure: HRQoL and Health economic (EQ-5D-5L)
timeFrame: 5 years post RT
measure: e-HL (eHLQ)
timeFrame: at baseline when inclusion/randomisation
measure: Communicative, critical and functional HL
timeFrame: at baseline when inclusion/randomisation
measure: Preparedness(PCSQ-24)
timeFrame: at CT planning visit, one week
measure: The Radiotherapy Experience Questionnaire, Swedish modified version
timeFrame: 3 weeks post RT
Other outcomes:
measure: Logged data from the CT machine
timeFrame: at Ct planning visit, one week
measure: Logged data from the CT machine
timeFrame: at Ct planning visit, one week
measure: Data from the journal
timeFrame: at Ct planning visit, one week
measure: Logged data from the RT machine
timeFrame: at Ct planning visit, one week
measure: Logged data from the CT machine
timeFrame: 3 weeks post RT
measure: Logged data from the CT machine
timeFrame: 3 weeks post RT
measure: Logged data from the journal
timeFrame: 3 weeks post RT
measure: Logged data from RT machine
timeFrame: 3 weeks post RT
measure: Measurement of chest mobility
timeFrame: at baseline when inclusion/randomisation
measure: Measurement of chest mobility
timeFrame: at planning CT, one week
measure: RMMI test
timeFrame: at planning CT visit, one week
measure: Planned and given absorbed RT dose to the heart during RT
timeFrame: baseline at inclusion /randomisation
measure: Planned and given absorbed RT dose to the heart during RT
timeFrame: 5 years post RT
measure: Demographic information. Modified version of The self-administrated comorbidity, The Self-Administered Comorbidity
timeFrame: baseline at inclusion/randomisation
measure: Demographic information, Modified version of The self-administrated comorbidities, The Self-Administered Comorbidity
timeFrame: 5 years follow up post RT
measure: Training patterns
timeFrame: from baseline at inclusion/randomisation
measure: Training patterns
timeFrame: up until the CT planning vistit, one week
measure: Environmental effects
timeFrame: 3 weeks post RT
measure: Focus group interview
timeFrame: 3 weeks post RT
Locations:
Study officials:
affiliation: Jonkoping University
name: maria Brovall, ass prof
role: PRINCIPAL_INVESTIGATOR
References: