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临床试验/NCT02391454
NCT02391454已完成不适用

Self-monitoring and Empowering Physical Activity With a SMARTphone Application During or After Cancer Treatment in a 12 Week Follow-up: a Randomized Feasibility Study (SMART-trial)

University Medical Center Groningen2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2015年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
2
主要终点
Calculate the effect-size of the RunKeeper app use for 12 weeks on PA as compared to usual care

研究概览

简要总结

Rationale: Cancer treatment is increasingly successful, resulting in a rising number of cancer survivors. A substantial number of survivors may experience long-term and late side effects from their cancer treatment. In addition, evidence is accumulating that an active lifestyle positively influences cancer treatment outcome and changes the recurrence rates of the disease. Therefore, physical activity (PA) programs are urgently needed and should be incorporated in current treatment regimens. It is noted though that cancer patients and survivors experience difficulties in remaining physically active. A 'smartphone application' (app) may be an accessible way to counteract these problems. The app 'RunKeeper', founded by Mr. Jason Jacobs, 2008, FitnessKeeper Inc. (RunKeeper) is a free, widely spread and well-known app for self-monitoring PA. Convenient features of RunKeeper are self-monitoring PA with GPS or stopwatch, recording progress, goal setting, and personal records. In this study the investigators aim to determine if the RunKeeper app use improves PA by self-monitoring and empowering PA during or after cancer treatment in comparison with usual care in a 12-week follow-up.

Objective: The primary objective is to identify an improvement in PA as measured by the PASE questionnaire when using the RunKeeper app in comparison with usual care for 12 weeks during or after cancer treatment. The investigators hypothesize that the RunKeeper app might assist in stimulating and improving PA behavior. Secondary objectives are to explore the usability of the RunKeeper app.

Study design: The present study is a single-centre prospective two-armed randomized controlled feasibility study.

Study population: Adult patients diagnosed with cancer currently being treated or under surveillance at the department of Medical Oncology at the UMCG.

Intervention: Patients who give informed consent will be randomized in one of the two study arms; 'Group A', usual care (N=15) or 'Group B', usual care + the RunKeeper app (N=15). Directly after randomization, Group B will be sent a brief user's manual for RunKeeper and requested to install the RunKeeper app. Group B will use the RunKeeper app for 12 weeks to self-monitor PA.

Main study parameters/endpoints: The primary endpoint is to calculate the effect-size of the RunKeeper app use for 12 weeks on PA as compared to usual care as measured by the Physical Activity Scale for the Elderly (PASE) questionnaire. The investigators hypothesize that the RunKeeper app might assist in stimulating and improving PA behavior.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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

  • Patients >18 years of age diagnosed with cancer (regardless of type/taxonomy) at the medical oncology department, UMCG
  • Patients undergoing cancer treatment or surveillance
  • WHO-performance score ≤1
  • Signed informed consent

排除标准

  • Inability to read or understand the Dutch language
  • Inability to handle or not in possession of a smartphone
  • Active user of the RunKeeper app
  • Severe cardiac (recent cardiovascular event) or psychiatric disease
  • Severe kidney or liver impairment
  • Pancytopenia
  • Patients following supervised oncologic rehabilitation

结局指标

主要结局

Calculate the effect-size of the RunKeeper app use for 12 weeks on PA as compared to usual care

时间窗: 12 weeks

The primary endpoint is to calculate the effect-size of the RunKeeper app use for 12 weeks on PA as compared to usual care as measured by the PASE.

次要结局

  • To explore the usability of the RunKeeper app use for 12 weeks.(12 weeks)
  • To explore patients' experiences of the usability of the RunKeeper app use for 12 weeks.(12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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