Lung CancerNCT05121259
Feasibility and Acceptability of an Web-based Physical Activity Program, for Those Diagnosed With Lung Cancer.
A study testing ExerciseGuide Intervention Group in people with Lung Cancer and Survivorship, run by University of Hull at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Survivorship
- What is being tested?
- ExerciseGuide Intervention Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Nov 2021to 11 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Queen's Centre for Oncology and Haematology (Castle Hill)
Hull, East Riding Of Yorkshire, HU16 5JQ
About this study
Official title: Feasibility and Acceptability of an Online Web-based Physical Activity Program, for Those Living With and Beyond 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.
Read more
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).
- Conditions
- Lung Cancer, Survivorship
- Being tested
- ExerciseGuide Intervention Group
- Keywords
- Physical Activity, Exercise, Digtial Technology
- Medical subject headings
- Lung Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseGuide Intervention GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Guide | Experimental | Single group feasibility group. Single group (intervention group) will be given access to the intervention (Exercise Guide UK) for eight-weeks. Receives: Other: ExerciseGuide Intervention Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 39 weeks
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.
Measured: 39 weeks
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.
Measured: 39 weeks
Secondary outcomes (7)
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).
Measured: Eight weeks
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.
Measured: Eight weeks
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.
Measured: Eight weeks
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.
Measured: Eight weeks
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.
Measured: Eight weeks
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.
Measured: Eight weeks
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.
Measured: Eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study start22 Nov 2021
- Primary completion8 Aug 2022
- Study completion11 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group feasibility study. Upon obtaining informed consent, participants will be allocated to the intervention group.
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hull
- Sponsor type
- University, hospital or other
- Collaborators
- Hull University Teaching Hospitals NHS Trust
- Responsible party
- Principal investigator, Cynthia Forbes, University of Hull
- Investigators
- Cynthia C Forbes, PhD, Study chair, University of Hull
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05121259
- Sponsor's protocol ID
- RS145-281450-JC
- Status last verified
- Oct 2022
- First submitted
- 20 Oct 2021
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will be retained and stored for five years within an online secure folder within the Hull York Medical School server. Post five years, the data will be permanently destroyed by IT services based at the University of Hull. Per the data management plan, data will be anonymised and presented in publications arising from this study, including but no limited to the doctoral thesis of Mr. Jordan Curry and scientific article publications. Only Dr Forbes and Mr Curry will have access to the full IPD. In the thesis, blank documents pertaining to this study (informed consent form, information document, etc), will be provided.
Publications
Curry J, Pearson M, Short CE, Vandelanotte C, Evans HEL, Lind M, Forbes CC. Feasibility and acceptability of ExerciseGuideUK for those living with and beyond lung cancer: a mixed methods study. Support Care Cancer. 2026 Jun 12;34(7):646. doi: 10.1007/s00520-026-10858-w.
PubMed 42277446Curry J, Lind M, Short CE, Vandelanotte C, Evans HEL, Pearson M, Forbes CC. Evaluating a web-based computer-tailored physical activity intervention for those living with and beyond lung cancer (ExerciseGuide UK): protocol for a single group feasibility and acceptability study. Pilot Feasibility Stud. 2022 Aug 13;8(1):182. doi: 10.1186/s40814-022-01129-6.
PubMed 35964141
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of an Online Web-based Physical Activity Program, for Those Living With and Beyond Lung Cancer.
- ClinicalTrials.gov ID
- NCT05121259
- Acronym / sponsor ID
- RS145-281450-JC
- Conditions
- Lung Cancer, Survivorship
- Keywords
- Physical Activity, Exercise, Digtial Technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of HullUniversity, hospital or other
- Collaborators
- Hull University Teaching Hospitals NHS Trust
- Study start
- 22 Nov 2021 (actual)
- Primary completion
- 8 Aug 2022 (actual)
- Study completion
- 11 Aug 2022 (actual)
- First posted
- 16 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group feasibility study. Upon obtaining informed consent, participants will be allocated to the intervention group.
| Arm | Type | Receives |
|---|---|---|
| Exercise Guide | Experimental | Other: ExerciseGuide Intervention GroupSingle group feasibility group. Single group (intervention group) will be given access to the intervention (Exercise Guide UK) for eight-weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- Psychological or linguistic inability to provide informed consent.
- Physical or psychological impairments which prevent or inhibit participation in physical activity. Examples include:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseGuide Intervention GroupThe 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. | Other | Exercise Guide |
Primary outcome
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.
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.
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: 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.
7 secondary outcomes
Quality of Life (or Global Health Status) 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
Time frame: Eight weeks
Pain will be assessed using the EORTC QLQ-C30 (version 3)
Time frame: Eight weeks
Breathlessness
Time frame: Eight weeks
Physical Functioning
Time frame: Eight weeks
Emotional Functioning
Time frame: Eight weeks
Hospital Anxiety Depression Scale (HADS)
Time frame: Eight weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Derived from this study: PubMed 42277446Curry J, Pearson M, Short CE, Vandelanotte C, Evans HEL, Lind M, Forbes CC. Feasibility and acceptability of ExerciseGuideUK for those living with and beyond lung cancer: a mixed methods study. Support Care Cancer. 2026 Jun 12;34(7):646. doi: 10.1007/s00520-026-10858-w.
- Derived from this study: PubMed 35964141Curry J, Lind M, Short CE, Vandelanotte C, Evans HEL, Pearson M, Forbes CC. Evaluating a web-based computer-tailored physical activity intervention for those living with and beyond lung cancer (ExerciseGuide UK): protocol for a single group feasibility and acceptability study. Pilot Feasibility Stud. 2022 Aug 13;8(1):182. doi: 10.1186/s40814-022-01129-6.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will be retained and stored for five years within an online secure folder within the Hull York Medical School server. Post five years, the data will be permanently destroyed by IT services based at the University of Hull. Per the data management plan, data will be anonymised and presented in publications arising from this study, including but no limited to the doctoral thesis of Mr. Jordan Curry and scientific article publications. Only Dr Forbes and Mr Curry will have access to the full IPD. In the thesis, blank documents pertaining to this study (informed consent form, information document, etc), will be provided.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia C Forbes, PhD study chair
University of Hull
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ExerciseGuide Intervention Group in people with Lung Cancer and Survivorship, run by University of Hull at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The recruitment rate (Website Feasibility) (time frame: 39 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05121259, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2022.