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临床试验/NCT07591376
NCT07591376已完成不适用

A Reminder App to Improve Physical Activity During Radiotherapy for Lung Cancer - a Pre-study in Healthy Volunteers

University Hospital Schleswig-Holstein2 个研究点 分布在 2 个国家目标入组 30 人开始时间: 2026年3月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2

研究概览

简要总结

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 fatigue or other adverse events.

The question arose whether an easy-to-use mobile app installed on the patient's smart phone reminding patients several times daily 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 has been developed within the Interreg project HeAT (Health Advancing Technologies for Elderly). However, before this app can be tested in a prospective trial involving patients, its usability should to be evaluated by healthy volunteers. In the present prospective study, 30 healthy volunteers test and rate ten aspects related to the usability of the app.

The healthy volunteers have to download a reminder app, which has been designed by the Lübeck based company Nextlabel Offene Handelsgesellschaft (OHG). After receiving the link for the download of the app from Nextlabel OHG by e-mail, the participants are asked to test the app and complete a questionnaire. They are asked to affirm or negate ten statements in three sections (download and installation, navigation, and content/functions) regarding the usability of the reminder app. The satisfaction rate represents the rate of participants who affirmed a statement. If this rate was <60%, the reminder app was rated as not being useful. If the rate was between ≥60% but <80%, the app was regarded useful but required further optimization regarding the corresponding section. In addition, iPhone and Android users are compared with respect to the satisfaction rates.

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. In a retrospective study of 184 cancer patients (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. 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 fatigue or other adverse events. The question arose whether an easy-to-use mobile app installed on the patient's smart phone reminding patients several times daily 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 has been developed within the Interreg project HeAT (Health Advancing Technologies for Elderly). However, before this app can be tested in a prospective trial involving patients, its usability should to be evaluated by healthy volunteers. In the present prospective study, 30 healthy volunteers test and rate ten aspects related to the usability of the app. This study will be followed by a clinical trial in lung cancer patients.

The primary objective of this study is to evaluate the usability of a reminder app designed to improve physical activity during radiation therapy for lung cancer. This is a prospective multi-center study (one arm), which is performed in 30 healthy volunteers. The healthy volunteers have to download a reminder app, which has been designed by the Lübeck based company Nextlabel OHG. After receiving the link for the download of the app from Nextlabel OHG by e-mail, the participants are asked to test the app and complete a questionnaire. They are asked to affirm or negate ten statements in three sections (download and installation, navigation, and content/functions) regarding the usability of the reminder app. The satisfaction rate represents the rate of participants who affirmed a statement. If this rate was <60%, the reminder app was rated as not being useful. If the rate was between ≥60% but <80%, the app was regarded useful but required further optimization regarding the corresponding section. In addition, iPhone and Android users are compared with respect to the satisfaction rates (Fisher's exact tests).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

入选标准

  • Possession of and ability to use a smart phone plus a step counter
  • Age ≥18 years
  • Written informed consent
  • Capacity of the participant to consent

排除标准

  • 1. Expected non-compliance

研究组 & 干预措施

Healthy volunteers evaluating a reminder app

Other

Participants are asked to test the app and complete a questionnaire. They are asked to affirm or negate ten statements in three sections (download and installation, navigation, and content/functions) regarding the usability of the reminder app.

干预措施: Questionnaire (Other)

研究者

发起方
University Hospital Schleswig-Holstein
申办方类型
Other
责任方
Sponsor

研究点 (2)

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