Supporting Women With Left Sided Breast Cancer to Practice Deep Inspiration Breath Hold (DIBH) at Home Before Radiation Therapy Treatment
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 160
- 主要终点
- Distress (DIS-A)
研究概览
简要总结
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.
详细描述
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)?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
A=Control group who receives customary information prior to RT with DIBH.
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.
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.
干预措施: 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)
结局指标
主要结局
Distress (DIS-A)
时间窗: 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.
Distress (DIS-A)
时间窗: 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.
Distress (DIS-A)
时间窗: 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.
Distress (DIS-A)
时间窗: 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.
Distress (DIS-A)
时间窗: 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.
次要结局
- HRQoL and Health economic (EQ-5D-5L)(5 years post RT)
- e-HL (eHLQ)(at baseline when inclusion/randomisation)
- Communicative, critical and functional HL(at baseline when inclusion/randomisation)
- Preparedness(PCSQ-24)(at CT planning visit, one week)
- The Radiotherapy Experience Questionnaire, Swedish modified version(3 weeks post RT)
- HRQoL and Health economic (EQ-5D-5L)(at baseline when inclusion/randomisation)
研究者
Maria Brovall
associated professor
Jonkoping University