Impact of a Reminder App on Physical Activity During Radiation Therapy for Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 32
- 试验地点
- 7
研究概览
简要总结
The primary objective of this prospective randomized trial is to explore whether the use of a smart phone-based reminder application is associated with a change in physical activity during radiation therapy in patients with lung cancer. The primary endpoint focuses on the within-patient change in physical activity between Week 1 and Week 5, with comparison between treatment groups to assess potential differences attributable to the intervention.
Secondary objectives include the exploratory assessment of patient satisfaction with the reminder app, its impact on the use and perception of digital health technology.
A total of 28 evaluable patients in the Full Analysis Set (approximately 14 per treatment arm) are required to detect a clinically relevant difference corresponding to a probability of superiority of approximately 0.65 with 80% power at a two-sided significance level of 0.05. Assuming that approximately 10% of patients will not be evaluable for the primary endpoint, a total of 32 patients will be randomized.
详细描述
Lung cancer belongs to the most common types of solid cancer in Europe and Northern America. A considerable number of patients with non-small cell lung cancer (NSCLC) and small-cell lung cancer (SCLC) receive conventionally fractionated radiation therapy with or without systemic treatment. Radiation therapy may be associated with adverse events affecting healthy tissues within the radiation field but also with fatigue and a decreased level of physical activity or function. Patients who experience significant treatment-related toxicity may not be able to receive the complete radiation therapy as planned. Maintaining or even improving the level of activity by physical exercise or walking a certain number of steps per day may be helpful in this context. A benefit of exercise has been suggested in a retrospective study of 184 cancer patients receiving neoadjuvant chemotherapy, including 31 patients with lung cancer. Adherence to an exercise program was associated with fewer dose reductions and delays of chemotherapy. Moreover, several studies performed in patients with lung cancer suggested that physical activity had a positive effect on the patient's quality of live. Furthermore, in a retrospective study of 50 patients who received chemotherapy for advanced or recurrent lung cancer, low physical activity was negatively associated with survival. Thus, physical activity prior to and during chemo- and/or immunotherapy for lung cancer appears important. This may also be true for patients with lung cancer treated with radiation therapy. However, adherence to an exercise program sometimes may be challenging for the patients, particularly if they experience treatment-related fatigue or other adverse events.
The question arose whether an app installed on the patient's smart phone reminding them several times per day to perform a certain number of steps will have a positive effect on their physical activity during a course of radiation therapy. Such an app was developed within the project Health Advancing Technologies for Elderly (HeAT). The current trial evaluates whether the use of the reminder app leads to a reduction of the intra-individual difference of the mean number of steps than without a reminder app.
The primary objective of this prospective randomized trial is to explore whether the use of a smart phone-based reminder application is associated with a change in physical activity during radiation therapy in patients with lung cancer.
The primary endpoint focuses on the within-patient change in physical activity between Week 1 and Week 5, with comparison between treatment groups to assess potential differences attributable to the intervention. Secondary objectives include the exploratory assessment of patient satisfaction with the reminder app, its impact on the use and perception of digital health technology.
This is a multicenter prospective randomized study conducted in patients undergoing radiation therapy for lung cancer. Patients will be randomized in a 1:1 ratio to receive either standard radiation therapy supported by the reminder application (Arm A) or standard radiation therapy without additional support (Arm B). In Arm A, patients are supported by a smart phone-based application that provides reminders three or four times per day (according to the patient's preference) to perform a predefined number of steps per day during the course of radiation therapy. In Arm B, patients receive standard care without the use of a reminder application. Physical activity will be assessed at predefined time point during treatment, specifically during Week 1 and Week 5 of radiation therapy, using step count data recorded by a smart phone application.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven lung cancer
- •Treatment with ≥50 Gy of conventionally fractionated radiation therapy
- •Possession of and ability to use a smart phone plus a step counter
- •Age ≥18 years
- •Written informed consent
- •Capacity of the patient to consent
排除标准
- •1. Expected non-compliance
