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NCT Number: NCT05121259

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

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).

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Key information

Conditions

Lung Cancer Behavior Lung Diseases Lung Neoplasms Motor Activity Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Survivorship Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen's Centre for Oncology and Haematology (Castle Hill)

Hull, East Riding Of Yorkshire, HU16 5JQ, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

ExerciseGuide Intervention Group

Other

The single group which will be given access to the eight-week ExerciseGuide UK website containing a tailored physical activity programme and supportive and educational resources.

Primary outcomes

  1. The recruitment rate (Website Feasibility)

    Time frame: 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.

  2. The retention rate (Website Feasibility)

    Time frame: 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.

  3. Participant Satisfaction (Acceptability)

    Time frame: 39 weeks

    The metric which will be assessed to explore acceptability will be satisfaction.

    Satisfaction will be explored in four approaches:

    • 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.
    • Real-time open-ended feedback will be collected upon the first completion of a module
    • 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.
    • 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.

Secondary outcomes

  1. Quality of Life (or Global Health Status) will be assessed using the EORTC QLQ-C30 (version 3).

    Time frame: Eight weeks

    Quality of Life (or Global Health Status) will be assessed using the EORTC QLQ-C30 (version 3). The scoring value will be provided as a numerical value from the questionnaire and compared at baseline and study completion.

    The questionnaire used a four-point Likert scale reporting method 1, "Not at all"; 2, "A Little"; 3, "Quite a bit"; and 4, "Very much" in relation to their agreement to statements. Two questions (Q29 ad Q30) use a seven-point Likert scale reporting method ranging from 1 (Very poor) to 7 (Excellent).

  2. Fatigue will be assessed using the EORTC QLQ-C30 (version 3

    Time frame: Eight weeks

    Fatigue will be assessed using the EORTC QLQ-C30 (version 3). The scoring value will be provided in a numerical value from the questionnaire and compared at baseline and study completion.

    The questionnaire used a four-point Likert scale reporting method 1, "Not at all"; 2, "A Little"; 3, "Quite a bit"; and 4, "Very much" in relation to their agreement to statements.

  3. Pain will be assessed using the EORTC QLQ-C30 (version 3)

    Time frame: Eight weeks

    Pain will be assessed using the EORTC QLQ-C30 (version 3). The scoring value will be provided in a numerical value from the questionnaire and compared at baseline and study completion.

    The questionnaire used a four-point Likert scale reporting method 1, "Not at all"; 2, "A Little"; 3, "Quite a bit"; and 4, "Very much" in relation to their agreement to statements.

  4. Breathlessness

    Time frame: Eight weeks

    Breathlessness will be assessed using the EORTC QLQ-C30 (version 3). The scoring value will be provided in a numerical value from the questionnaire and compared at baseline and study completion.

    The questionnaire used a four-point Likert scale reporting method 1, "Not at all"; 2, "A Little"; 3, "Quite a bit"; and 4, "Very much" in relation to their agreement to statements.

  5. Physical Functioning

    Time frame: Eight weeks

    Physical functioning will be assessed using the EORTC QLQ-C30 (version 3). The scoring value will be provided in a numerical value from the questionnaire and compared at baseline and study completion.

    The questionnaire used a four-point Likert scale reporting method 1, "Not at all"; 2, "A Little"; 3, "Quite a bit"; and 4, "Very much" in relation to their agreement to statements.

  6. Emotional Functioning

    Time frame: Eight weeks

    Emotional functioning will be assessed using the EORTC QLQ-C30 (version 3). The scoring value will be provided in a numerical value from the questionnaire and compared at baseline and study completion.

  7. Hospital Anxiety Depression Scale (HADS)

    Time frame: Eight weeks

    Hospital Anxiety Depression Scale (HADS) will be used pre-and post-study to explore changes in anxiety and depression.

    The HADS assigns statements to a numerical value (between 0 and 3) which is selected in agreement to the statement. These scores are totalled providing an overall score for both Anxeity and Depression.

Sponsors and collaborators

Lead sponsor

University of Hull

Other

Collaborators

  • Hull University Teaching Hospitals NHS Trust

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 16, 2021
Registry last updated
Nov 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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