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

Официальное название

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

Обзор

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.

Подробное описание

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)?

Вмешательства

• Другое 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 sess

Первичные конечные точки

• Distress (DIS-A) [Срок оценки: Time 1, baseline at randomisation/inclusion]
• Distress (DIS-A) [Срок оценки: time 2, at CT-planning visit one week]
• Distress (DIS-A) [Срок оценки: time 3, 3 weeks post RT]
• Distress (DIS-A) [Срок оценки: time 4, 6 month post RT]
• Distress (DIS-A) [Срок оценки: time 5, 5 years after RT]

Вторичные конечные точки (6)

• HRQoL and Health economic (EQ-5D-5L) [Срок оценки: at baseline when inclusion/randomisation]
• HRQoL and Health economic (EQ-5D-5L) [Срок оценки: 5 years post RT]
• e-HL (eHLQ) [Срок оценки: at baseline when inclusion/randomisation]
• Communicative, critical and functional HL [Срок оценки: at baseline when inclusion/randomisation]
• Preparedness(PCSQ-24) [Срок оценки: at CT planning visit, one week]
• The Radiotherapy Experience Questionnaire, Swedish modified version [Срок оценки: 3 weeks post RT]

Критерии участия

Критерии включения

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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT05791084 · 2021-04031

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗