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

October 31, 2022 updated by: Cynthia Forbes, University of Hull

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.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • East Riding Of Yorkshire
      • Hull, East Riding Of Yorkshire, United Kingdom, HU16 5JQ
        • Queen's Centre for Oncology and Haematology (Castle Hill)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise Guide
Single group feasibility group. Single group (intervention group) will be given access to the intervention (Exercise Guide UK) for eight-weeks.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
39 weeks
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.
39 weeks
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.
39 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Eight weeks
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.
Eight weeks
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.
Eight weeks
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.
Eight weeks
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.
Eight weeks
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.
Eight weeks
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.
Eight weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Hull

Collaborators

Hull University Teaching Hospitals NHS Trust

Investigators

  • Study Chair: Cynthia C Forbes, PhD, University of Hull

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2021

Primary Completion (Actual)

August 8, 2022

Study Completion (Actual)

August 11, 2022

Study Registration Dates

First Submitted

October 20, 2021

First Submitted That Met QC Criteria

November 15, 2021

First Posted (Actual)

November 16, 2021

Study Record Updates

Last Update Posted (Actual)

November 1, 2022

Last Update Submitted That Met QC Criteria

October 31, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RS145-281450-JC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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