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临床试验/NCT05121259
NCT05121259已完成不适用

Feasibility and Acceptability of an Online Web-based Physical Activity Program, for Those Living With and Beyond Lung Cancer.

University of Hull2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2021年11月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
18
试验地点
2
主要终点
The recruitment rate (Website Feasibility)

研究概览

简要总结

Lung cancer is a life changing disease which can cause negative effects on an individual's ability to perform daily tasks and their quality of life (QoL). Lung cancer is the third most common cancer in the UK and is estimated affects approximately 33,000 individuals per year.

The most common side effects from lung cancer and treatments are breathlessness, fatigue, nausea, diarrhoea, and depression. Those living beyond cancer often suffer from extreme feelings of isolation and have increased chance of cardiovascular disease and diabetes.

Physical activity is a vital component of the prevention and management of cancer. Being active can improve one's physical health (ability to carry out tasks of daily living and breathlessness) and emotional wellbeing (feelings of depression and isolation).

Electronic platforms (websites and mobile applications) are increasingly popular within developing nations, particularly with products that aim to increase and keep track of physical activity. Though, literature suggests older adults prefer websites opposed to mobile applications. Online delivery of physical activity could be highly beneficial for patients living with and beyond cancer, reducing the location-based inequality of those who can not attend face-to-face programmes, allowing individuals to carry out a session whenever they can, in the comfort of their own home.

Exploring how those living with and beyond lung cancer use a website and investigating the feasibility and acceptability on an online platform which aims to provide tailored physical activity programs will provide fundamental data and possible supporting data for a randomised controlled trail (RCT).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
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

  • Be 18 years of age or older.
  • Have had a lung cancer diagnosis.
  • Be able to speak and read in English.
  • Willing and able to provide informed consent.
  • Have internet connectivity.
  • Access to a laptop, computer, or smart device to access the web-based platform.

排除标准

  • Psychological or linguistic inability to provide informed consent.
  • Physical or psychological impairments which prevent or inhibit participation in physical activity. Examples include:
  • Uncontrolled atrial fibrillation
  • Abdominal aortic aneurysm (AAA)
  • Recent heart attack (less than one year)
  • Recent stroke (less than one year)
  • Psychiatric disorder
  • Those who lack capacity under the Mental Capacity Act 2005 (MCA).

结局指标

主要结局

The recruitment rate (Website Feasibility)

时间窗: 39 weeks

The recruitment rate will be established by the number of potential participants approached and how many agree to participate. The recruitment rate will be provided in a factorial or percentage format.

The retention rate (Website Feasibility)

时间窗: 39 weeks

The retention rate will be given based on the initial value of those who provide consent vs those who complete the eight-week intervention. The retention rate will be provided in a factorial or percentage format.

Participant Satisfaction (Acceptability)

时间窗: 39 weeks

The metric which will be assessed to explore acceptability will be satisfaction. Satisfaction will be explored in four approaches: 1. Satisfaction via research team developed questionnaire. The questionnaire will be a five-point Likert scale reporting method from "Strongly Agree" to "Strongly Disagree" in relation to their agreement to statements. 2. Real-time open-ended feedback will be collected upon the first completion of a module 3. Systems Usability Scale (Brooke, 1986). The 10-item questionnaire will provide a five-point Likert scale reporting method from "Strongly Agree" to "Strongly Disagree" in relation to their agreement to statements. 4. A selection of participants based on recruitment will be asked to take part in an interview to further explore satisfaction and acceptability. An interview guide covering the experience of using the website, concerns, and suggested revisions will be followed. The interviews will be transcribed verbatim and analysed.

次要结局

  • Breathlessness(Eight weeks)
  • Fatigue will be assessed using the EORTC QLQ-C30 (version 3(Eight weeks)
  • Physical Functioning(Eight weeks)
  • Emotional Functioning(Eight weeks)
  • Pain will be assessed using the EORTC QLQ-C30 (version 3)(Eight weeks)
  • Quality of Life (or Global Health Status) will be assessed using the EORTC QLQ-C30 (version 3).(Eight weeks)
  • Hospital Anxiety Depression Scale (HADS)(Eight weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cynthia Forbes

Career Development Fellow

University of Hull

研究点 (2)

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