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

Jonkoping University

Status: Not yet enrolling

Conditions: Preparedness; Mobile Application; Distress, Emotional; Health Literacy

Treatments: 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.

Study type: Interventional

Funder types: Other

Identifiers

NCT05791084

2021-04031

Details and patient eligibility

About

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.

Full 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)?

Enrollment: 160 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

A=Control group who receives customary information prior to RT with DIBH.

No Intervention group

Description:

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 group

Description:

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.

Treatment:

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.