NCT05121259

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable lung-cancer

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2021

Completed
27 days until next milestone

First Posted

Study publicly available on registry

November 16, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

November 22, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2022

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2022

Completed
Last Updated

November 1, 2022

Status Verified

October 1, 2022

Enrollment Period

9 months

First QC Date

October 20, 2021

Last Update Submit

October 31, 2022

Conditions

Keywords

Physical ActivityExerciseDigtial Technology

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • Participant Satisfaction (Acceptability)

    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 Outcomes (7)

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

    Eight weeks

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

    Eight weeks

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

    Eight weeks

  • Breathlessness

    Eight weeks

  • Physical Functioning

    Eight weeks

  • +2 more secondary outcomes

Study Arms (1)

Exercise Guide

EXPERIMENTAL

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

Interventions

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.

Exercise Guide

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

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

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Lung NeoplasmsMotor Activity

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesBehavior

Study Officials

  • Cynthia C Forbes, PhD

    University of Hull

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single group feasibility study. Upon obtaining informed consent, participants will be allocated to the intervention group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Career Development Fellow

Study Record Dates

First Submitted

October 20, 2021

First Posted

November 16, 2021

Study Start

November 22, 2021

Primary Completion

August 8, 2022

Study Completion

August 11, 2022

Last Updated

November 1, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

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.

Locations