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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05121259
• Other study ID #: RS145-281450-JC
• Status: Completed
• Phase: N/A
• Start date: November 22, 2021
• Est. completion date: August 11, 2022

Study information

• Verified date: October 2022
• Source: University of Hull
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: August 11, 2022
• Est. primary completion date: August 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Survivorship

Intervention

Other:
• ExerciseGuide Intervention Group
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.

Locations

Country	Name	City	State
United Kingdom	Queen's Centre for Oncology and Haematology (Castle Hill)	Hull	East Riding Of Yorkshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Hull	Hull University Teaching Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The recruitment rate (Website Feasibility)	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.	39 weeks
Primary	The retention rate (Website Feasibility)	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.	39 weeks
Primary	Participant Satisfaction (Acceptability)	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.	39 weeks
Secondary	Quality of Life (or Global Health Status) will be assessed using the EORTC QLQ-C30 (version 3).	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).	Eight weeks
Secondary	Fatigue will be assessed using the EORTC QLQ-C30 (version 3	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.	Eight weeks
Secondary	Pain will be assessed using the EORTC QLQ-C30 (version 3)	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.	Eight weeks
Secondary	Breathlessness	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.	Eight weeks
Secondary	Physical Functioning	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.	Eight weeks
Secondary	Emotional Functioning	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.	Eight weeks
Secondary	Hospital Anxiety Depression Scale (HADS)	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.	Eight weeks

External Links

•   Exercise Guide UK