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

Primary Purpose

Lung Cancer, Survivorship

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
ExerciseGuide Intervention Group
Sponsored by
University of Hull
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring Physical Activity, Exercise, Digtial Technology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exercise Guide

Arm Description

Single group feasibility group. Single group (intervention group) will be given access to the intervention (Exercise Guide UK) for eight-weeks.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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).
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.
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.
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.
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.
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.
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.

Full Information

First Posted
October 20, 2021
Last Updated
October 31, 2022
Sponsor
University of Hull
Collaborators
Hull University Teaching Hospitals NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT05121259
Brief Title
Feasibility and Acceptability of an Web-based Physical Activity Program, for Those Diagnosed With Lung Cancer.
Official Title
Feasibility and Acceptability of an Online Web-based Physical Activity Program, for Those Living With and Beyond Lung Cancer.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
November 22, 2021 (Actual)
Primary Completion Date
August 8, 2022 (Actual)
Study Completion Date
August 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Hull
Collaborators
Hull University Teaching Hospitals NHS Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Survivorship
Keywords
Physical Activity, Exercise, Digtial Technology

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single group feasibility study. Upon obtaining informed consent, participants will be allocated to the intervention group.
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise Guide
Arm Type
Experimental
Arm Description
Single group feasibility group. Single group (intervention group) will be given access to the intervention (Exercise Guide UK) for eight-weeks.
Intervention Type
Other
Intervention Name(s)
ExerciseGuide Intervention Group
Intervention Description
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 Outcome Measure Information:
Title
The recruitment rate (Website Feasibility)
Description
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.
Time Frame
39 weeks
Title
The retention rate (Website Feasibility)
Description
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.
Time Frame
39 weeks
Title
Participant Satisfaction (Acceptability)
Description
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.
Time Frame
39 weeks
Secondary Outcome Measure Information:
Title
Quality of Life (or Global Health Status) will be assessed using the EORTC QLQ-C30 (version 3).
Description
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).
Time Frame
Eight weeks
Title
Fatigue will be assessed using the EORTC QLQ-C30 (version 3
Description
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.
Time Frame
Eight weeks
Title
Pain will be assessed using the EORTC QLQ-C30 (version 3)
Description
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.
Time Frame
Eight weeks
Title
Breathlessness
Description
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.
Time Frame
Eight weeks
Title
Physical Functioning
Description
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.
Time Frame
Eight weeks
Title
Emotional Functioning
Description
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.
Time Frame
Eight weeks
Title
Hospital Anxiety Depression Scale (HADS)
Description
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.
Time Frame
Eight weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia C Forbes, PhD
Organizational Affiliation
University of Hull
Official's Role
Study Chair
Facility Information:
Facility Name
Queen's Centre for Oncology and Haematology (Castle Hill)
City
Hull
State/Province
East Riding Of Yorkshire
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
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.
Citations:
PubMed Identifier
35964141
Citation
Curry 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.
Results Reference
derived
Links:
URL
https://www.exerciseguide.org.uk/eng/pages/homepage
Description
Exercise Guide UK

Learn more about this trial

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

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