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

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

NCT ID: NCT05791084

Condition: Health Literacy
Distress, Emotional
Preparedness
Mobile Application

Conditions: Keywords:
DIBH
RCT
radiotherapy
mobile application
distress

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: RCT with an intervention and control group

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: 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.
Description: 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).
Arm group label: B=Intervention group usual care and the DIBH-App to practice at-home before RT with DIBH.

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)?

Criteria for 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.

Gender: Female

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Start date: September 1, 2023

Completion date: March 30, 2029

Lead sponsor:
Agency: Jonkoping University
Agency class: Other

Source: Jonkoping University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05791084