Investigating the Feasibility of a Physical Activity (tele)coachingv Intervention in Patients with Non-small Cell Lung Cancer: an Explorative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 4
- 主要终点
- Acceptability of the coaching programs
研究概览
简要总结
The aim of this study is to investigate the acceptability, actual usage, feasibility and safety of 1) a (semi) automated PA tele coaching intervention including smartphone application and stepcounter (Fitbit Charge 4) and 2) a manual PA tele coaching program using only a stepcounter (Fitbit Charge 4) without custom smartphone application but still linked with a smartphone using the Fitbit application and to make population specific adaptations to the intervention for patients with NSCLC after lung resection surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Three to nine months after a lung resection surgery for non-small cell lung cancer
- •If patients received adjuvant chemotherapy, the inclusion window will be three months to nine months after the end of adjuvant chemotherapy
- •Adults (+18 year)
排除标准
- •Progressive or recurrent lung cancer
- •Who had other malignancies in the last 2 years
- •Psychiatric disorders
- •Other ongoing treatments
- •Involved in or planned to start a multidisciplinary rehabilitation program
- •Unable to learn to work with a new electronic device (e.g. smartphone)
- •Not understanding and speaking Dutch
- •Patients with comorbidities precluding them from participation in a physical activity intervention
结局指标
主要结局
Acceptability of the coaching programs
时间窗: 9 weeks after the inclusion of the patient
(i.e. to what extent patients receiving the intervention consider it as appropriate) Acceptability will be assessed through quantitative data (a project-tailored questionnaire) and qualitative data collection (patient interview with open questions). Patients will be asked to fill in a self-administered, project-tailored, multiple choice questionnaire on their experiences with the intervention. Patient interviews with open questions will be conducted by the local PA coach in each center.
Feasibility of the coaching programs
时间窗: 9 weeks after the inclusion of the patient
(i.e. the extent to which the treatment can be successfully used within a given setting). Feasibility will be assessed through quantitative data (a project-tailored questionnaire) and qualitative data collection (patient interview with open questions). Patients will be asked to report the smartphone intervention and use of the step counter and indicate if it was not too much of a burden to work with when they are asked how they have experienced the technical aspects of the intervention. Coaches will collect contact time with patients and preparation time in a logbook in an Excel file. Also, how many times patients are contacted and the number of technical problems will be collected.
Actual usage of the coaching programs
时间窗: During the whole 8-week intervention
(i.e. the degree to which patients use the components of the intervention as it was designed) Actual usage of the custom application by patients will be assessed objectively through the smartphone app log (for participants in the ACP group). This will include information about completion of the app tasks and step counter data on a day-by-day basis and will be automatically collected in the back-end of the application. Actual usage of the step counter (for participants in both intervention groups) will be defined based on the presence of step count data (ie, ≥70 steps for that day). The frequency at which patients looked at their step counter will be assessed subjectively in the project-tailored questionnaire.
Safety of the coaching programs
时间窗: During the whole 8-week intervention
Detailed information of any adverse event (AE) will be collected during the pilot phase. Description, severity, start and stop, seriousness, outcome and relation to the intervention will be described for every reported AE. If problems occur during the intervention, patients are asked to contact the coach to discuss possible AE's. If necessary, an extra visit or consultation with a physician will be scheduled. During each patient contact coaches will also seek information on AE's. All events, whether reported by the patient or noted by the coach, will be recorded in the patient's medical record and in the (e)CRF within a reasonable time after becoming aware.
次要结局
- Symptoms(1 week before the start of the intervention and immediately after the 8-week intervention)
- Physical activity(1 whole week after inclusion and 1 whole week after the 8-week intervention)
- Functional exercise capacity(1 week before the start of the intervention and immediately after the 8-week intervention)
- Quality of Life - EORTC QLQ-C30-LC13(1 week before the start of the intervention and immediately after the 8-week intervention)
研究者
Chris Burtin
Associate Professor
Hasselt University