跳至主要内容
临床试验/NCT05927636
NCT05927636招募中不适用

Systemic Treatment Related Toxicity Identified With a Smartphone APPlication Measuring Step Count - Prospective Cohort Study

Radboud University Medical Center3 个研究点 分布在 1 个国家目标入组 411 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
411
试验地点
3
主要终点
Number of patients with a RDI <70%

研究概览

简要总结

The goal of this observational study is to investigate whether daily physical activities measured with a smartphone are related to the possible side effects or other physical complaints that arise as a result of cancer treatment. The investigators want to test whether the number of steps per day, both before and during treatment, are related to possible side effects or other physical complaints of the treatment using a smartphone. Knowledge about this relationship gives us possible starting points to prevent and/or reduce side effects and improve treatment outcomes. Additional research would then be needed.

The investigators also want to investigate whether these daily measurements are feasible for patients undergoing treatment.

Participation in the study involves measuring daily physical activity from the week before treatment until the first 3 months of treatment have been completed. This is done by tracking daily steps with patients own phone using the OncoSTAPP application.

详细描述

Rationale: Systemic treatment of patients with cancer has a multimodal approach with the goal of balancing quantity and quality of life. Treatment decisions are influenced by tumour and patient-related characteristics. Additionally, in clinical practice performance status is used to identify whether a patient is sufficiently fit for systemic treatment, as it has shown to be a valid prognostic factor for survival and adverse events during treatment. However, treatment-related toxicities and hospitalisations occur frequently during systemic treatment.

The disadvantages of performance status assessed with ECOG or Karnofsky, is that it is a subjective measurement which is prone to bias and has high interobserver variability. Also a patient's self-reported physical function is significantly associated with shorter (progression-free) survival, but it is also subjective and is prone to multiple forms of bias. Objective assessment of physical function might be a good alternative to counteract these shortcomings. A higher level of physical activity is associated with a reduction in cancer specific mortality and can be measured with accelerometers, pedometers or multisenor systems like smartphones.

Wearable measured step count assessed with a wrist worn device provided by the investigators has shown to be associated with adverse events. However, these devices cannot be provided to all patients in clinical practice.

Recently, the investigators showed that the smartphones' assessments of physical activity (step count), have excellent agreement with accelerometer assessments of physical activity and good test-retest reliability. Furthermore this smartphone measurements were associated with early trial discontinuation in phase 1/2 cancer trials.

The investigators hypothesize that a low baseline and/or a reduction in physical activity (step count) measured with smartphones will be predictive for clinically relevant adverse events during systemic treatment. Adding objective information of physical function in the process of selecting the best treatment for a patient may help prevent unnecessary adverse events. Additionally, a detection of a decline in physical activity during treatment may identify upcoming adverse events early, allowing timely management/support. This may help to optimize treatment and quality of life.

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

入选标准

  • Age ≥18 years;
  • Diagnosis of cancer with an indication of starting systemic treatment
  • Knowledge how to handle smartphone with iOS version 11 or higher or Android version 7.0 or higher.
  • Mastery of Dutch language
  • Able and willing to give written informed consent

排除标准

  • Cognitive disorders or severe emotional instability
  • Wheelchair-depended at home, or immobile due to for example fracture
  • Already participating in an exercise trial

结局指标

主要结局

Number of patients with a RDI <70%

时间窗: From enrollment to the end of observation period (90 days on systemic treatment)

Relative dose intensity (RDI) below 70%; will be combined into Clinically relevant adverse events during treatment

Rate of mortality

时间窗: From enrollment to the end of observation period (90 days on systemic treatment)

Mortality due to treatment toxicity; will be combined into Clinically relevant adverse events during treatment

Number of patients with a hospitalization

时间窗: From enrollment to the end of observation period (90 days on systemic treatment)

Hospitalizations during treatment related to the therapy; will be combined into Clinically relevant adverse events during treatment

Physical activity

时间窗: From enrollment to the end of observation period (90 days on systemic treatment)

Mean number of steps per day measured with a smartphone. At baseline and during treatment

Number of patients with a treatment discontinuation

时间窗: From enrollment to the end of observation period (90 days on systemic treatment)

Early treatment discontinuation, within the first 3 months; will be combined into Clinically relevant adverse events during treatment

Relative dose intensity (RDI) of systemic treatment

时间窗: From enrollment to the end of observation period (90 days on systemic treatment)

The percentage of planted dose and time between doses will be retrieved form patients' medical records (EPIC). The RDI will be calculated by total percentage of given dose divided by the proportion of the actual time in relation to the standard time. RDI=(Total percentage of given dose)/((Actual time)/(Standard time))\*100

次要结局

  • Physician's rated performance status(At enrollment)
  • Oncologists' estimates of high toxicity risk during treatment(At enrollment)
  • Progression free survival(From enrollment until the date of first documented progression assessed up to 2 years)
  • Proportion of patients with correctly collected data(From enrollment to the end of observation period (90 days on systemic treatment))
  • Patients experience with smartphone application(At the end of the observation period (90 days on systemic treatment), or reported spontaniously by the patient)
  • Overall survival(From enrollment until the date of death from any cause, assessed up to 2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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