Remote Monitoring of Wearable Activity Trackers for Detection of TOXicity in People Receiving Systemic Anticancer Treatment: a Feasibility Study
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Feasibility of undertaking a timely ambulatory review, of participants in whom a reduction of steps is detected
研究概览
简要总结
Accurate evaluation of activity status is an important part of the assessment of people with cancer. Clinician assessments currently used are valuable but have limitations; in particular, assessment only occurs when the patient attends clinic and is often subjective. Activity trackers, such as FitBits, give the opportunity to objectively assess activity status continuously, independent of clinic visits. Previous studies have shown that a reduction in 1000 steps while receiving cancer treatment is associated with an increased risk of hospitalisation but it is not known if using information from activity trackers to allow early intervention is feasible or if it can reduce admission to hospital and improve outcomes.
The investigators propose a prospective feasibility study in people with advanced lung cancer or upper gastrointestinal cancers who are starting a new line of systemic anti-cancer therapy.
Participants will receive a FitBit, which is a commercially available wearable activity tracker for the duration of their treatment or 4 months (whichever is shorter). Step counts will be monitored and a reduction in daily steps of >1000 from baseline will trigger contact by the study team and an ambulatory review. Participants will not receive treatment within the context of the study.
详细描述
A recent metanalysis reports that over 40% of people with cancer being treated with palliative intent have at least 1 unplanned hospital admission during treatment. Furthermore, up to 83% of people undergoing cancer treatment are likely to attend the Emergency Departments (ED). The 2019 NHS long-term plan has an emphasis on the use of digital technologies, remote monitoring to support patients, and acute ambulatory care as an alternative to ED attendance.
In observational studies of people with cancer, reductions in steps counts correlate with increased symptoms and risk of hospitalisation.
Therefore, the main aim of this study is to determine whether monitoring of activity and subsequent ambulatory review triggered by detecting a reduction in steps is feasible in a timely fashion within an NHS oncology centre.
People with advanced lung cancer (NSCLC, SCLC) or upper gastrointestinal cancers (gastric, oesophageal or pancreatic) starting a new line of systemic anti-cancer treatment (SACT) will be recruited at The Royal Marsden Hospital (Chelsea and Sutton sites). Eligible patients will be approached by clinical teams in the lung and gastrointestinal cancer outpatient clinics.
Participants who are due to start a new line of SACT will be asked to wear a FitBit activity tracker (resembling a watch). Baseline median daily steps count will be calculated prior starting SACT for those patients who wear the device for ideally 7 consecutive days, which must include both weekend and week days.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Advanced lung (NSCLC or SCLC) cancer or patients with upper gastrointestinal cancer (gastric, oesophageal, pancreatic) starting a new line of systemic anti-cancer therapy.
- •Willingness to wear an activity tracker and undergo remote monitoring
- •Access to a smart phone.
- •Willingness to have a Fitbit App installed on their smartphone
- •Willingness to have a pseudo- anonymised FitBit account created for the purposes of the study
- •1 or more previous lines of treatment.
排除标准
- •Physical conditions that preclude daily walking
- •Inability to give informed consent.
- •Medical or psychiatric condition which in the investigators opinion would affect the successful completion of the study.
- •Immediate need to start systemic anticancer therapy
结局指标
主要结局
Feasibility of undertaking a timely ambulatory review, of participants in whom a reduction of steps is detected
时间窗: Analysis 4 months after last patient recruited
Feasibility of a timely ambulatory review will be determined by measuring the proportion of participants who are invited for an ambulatory review and attend within 24 hours. If 70% of participants invited for a review attend, this will be considered feasible.
Feasibility of monitoring reductions in step count in people with advanced lung cancer or upper gastrointestinal cancers starting systemic anti-cancer therapy.
时间窗: Analysis 4 months after last patient recruited
Feasibility of step count monitoring will be determined by measuring the proportion of participants for whom step count was successfully monitored (step count checked for at least 4 out 5 weekdays) for at least 80% of the treatment weeks during the study period. Successful monitoring is defined as a member of the study team logging in to the Fitabase system to review the step count. If 80% of participants are monitored for 80% of the observational time (from the start until the end of treatment - either at completion or if treatment is stopped), this will be considered feasible.
次要结局
- Utility of monitoring steps counts as a trigger for ambulatory assessment for the identification of new or worsening adverse events in people with cancer.(Analysis 4 months after last patient recruited)
- Sensitivity of monitoring steps counts for the identification of new or worsening adverse events in people with cancer(Analysis 4 months after last patient recruited)
- Number of hospitalisation episodes.(Analysis 4 months after last patient recruited)
- Participant compliance with use of activity monitor(Analysis 4 months after last patient recruited)
- Proportion of hospitalisation episodes associated with WAT-triggered ambulatory reviews.(Analysis 4 months after last patient recruited)
- Acceptability of remote activity tracking(At study completion, approximately 1 year after beginning recruitment)