A study to test an exercise and self-management application for people living with lung cancer
| ISRCTN | ISRCTN13603798 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13603798 |
| Integrated Research Application System (IRAS) | 333306 |
| Research Registry | 10619 |
| Sponsor | Oxford Brookes University |
| Funders | Oxford Brookes University, North Bristol NHS Trust |
- Submission date
- 10/02/2026
- Registration date
- 19/02/2026
- Last edited
- 16/02/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Lung cancer is one of the most common cancers worldwide and remains the leading cause of cancer-related death. Although treatments and early diagnosis have improved, many people living with lung cancer experience ongoing symptoms such as fatigue, breathlessness, and low mood. These symptoms can significantly affect physical function and quality of life.
Regular physical activity and exercise can help improve these symptoms and overall well-being. However, many people with lung cancer find it difficult to access or maintain exercise and rehabilitation programmes due to travel difficulties, health limitations, or other practical barriers. Digital health technologies, such as mobile and web-based applications, may offer a flexible and accessible way to support self-management and physical activity at home.
Researchers at Oxford Brookes University have co-developed a new digital self-management app specifically for people living with lung cancer, building on earlier pulmonary rehabilitation and exercise apps. The aim of this study is to test a beta version of the HandHeld Health Lung Cancer App to assess its acceptability and feasibility. The study will explore whether using the app can improve physical functioning, symptom management, health-related quality of life, and engagement in physical activity.
Who can participate?
Patients aged 18 years and over living with lung cancer who can use a smartphone, tablet, or computer, and are interested in using a digital app to support physical activity and self-management of symptoms. Additional eligibility criteria will be considered by the research team to ensure that participation is appropriate and safe.
What does the study involve?
Participants will be asked to use the HandHeld Health Lung Cancer App over a defined study period. The app enables users to record symptoms and physical activity, receive personalised exercise recommendations, and monitor changes in activity levels and symptoms over time. Participants will also be asked to complete questionnaires assessing health-related quality of life, digital proficiency, and symptom burden, and to complete physical functioning assessments at study visits. Participants will be invited to semi-structured interviews to provide feedback on their experience of using the app to inform further development and optimisation.
What are the possible benefits and risks of participating?
Potential benefits include improved self-management of symptoms, increased engagement in physical activity, greater awareness of physical functioning and wellbeing, and contribution to the development of a digital self-management intervention tailored to people living with lung cancer.
The risks associated with participation are expected to be minimal. Engagement in exercise-based activities may cause mild fatigue or discomfort, similar to that experienced during routine physical activity. The app is designed to promote safe and appropriate activity, and participants are encouraged to exercise within their individual capabilities. Participants will be advised to seek support from their usual healthcare team should any concerns arise.
Where is the study run from?
The study is sponsored by Oxford Brookes University. Study visits will occur at the Headington Campus Oxford Brookes University, Oxford OR Southmead Hospital, North Bristol NHS Trust, Bristol.
When is the study starting and how long is it expected to run for?
September 2024 to July 2025
Who is funding the study?
1. Oxford Brookes University (UK)
2. North Bristol NHS Trust (UK)
Who is the main contact?
Suriya Kirkpatrick, 19228607@brookes.ac.uk
Contact information
Principal investigator, Public, Scientific
Headington Campus
Oxford
OX3 0BP
United Kingdom
| Phone | +44 (0)7909921833 |
|---|---|
| 19228607@brookes.ac.uk |
Study information
| Primary study design | Interventional | |
|---|---|---|
| Allocation | Non-randomized controlled trial | |
| Masking | Open (masking not used) | |
| Control | Uncontrolled | |
| Assignment | Single | |
| Purpose | Device feasibility, Health services research, Supportive care | |
| Scientific title | A study to assess the feasibility of an exercise-based digital self-management platform for people living with lung cancer | |
| Study acronym | LungFit | |
| Study objectives | Primary objectives: 1. To measure participant uptake to a digital platform designed to empower them to self-manage their condition 2. To evaluate participant adherence to the exercise plan over an 8-week period 3. To assess acceptability and usefulness of the digital platform 4. To identify any barriers and facilitators to using an exercised based digital platform for people with lung cancer Secondary objectives: 1. To identify any potential safety issues for patients in using the digital platform 2. To explore whether a structured exercise based digital intervention has the potential to support a person diagnosed with lung cancer to increase their level of physical activity, health related quality of life and common symptoms of lung cancer, breathlessness, fatigue, and depression 3. To evaluate the feasibility of the outcome measures for the population under study | |
| Ethics approval(s) |
Approved 29/08/2024, HRA Seasonal REC (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; Not available; seasonal.rec@hra.nhs.uk), ref: 24/LO/0590 | |
| Health condition(s) or problem(s) studied | Lung cancer | |
| Intervention | Participants in this study will receive access to the HandHeld Health (HHH) lung cancer app from weeks 1 to 8. The app includes a bespoke exercise recommendation, useful information on increasing physical activity and management of common symptoms of breathlessness, fatigue, and depression. From week 0 to week 1 baseline activity data will be collected using the fitness tracker. During weeks 1-8 the participant will be encouraged to access the exercise prescription at least 3 times a week to complete the strength-based exercises and log any additional activity they might undertake. Patients will be followed up weekly (from baseline to week 9) by the lead researcher-to answer any questions/concerns, ensure the activity diary is being completed, troubleshoot any technology issues and undertake safety assessments. Baseline, end of weeks 4 and 9 follow up will be carried out face to face. In exceptional circumstances, where a participant is unable to attend the face-to-face visit at week 4 or 9, a remote visit will be conducted via telephone or Zoom. However, some functional assessments and vital signs will not be completed. | |
| Intervention type | Device | |
| Phase | Not Applicable | |
| Drug / device / biological / vaccine name(s) | HandHeld Health Lung Cancer Application (HHH-LC App) | |
| Primary outcome measure(s) |
| |
| Key secondary outcome measure(s) |
| |
| Completion date | 31/07/2025 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 99 Years |
| Sex | All |
| Target sample size at registration | 15 |
| Total final enrolment | 30 |
| Key inclusion criteria | 1. Aged ≥18 years 2. Confirmed diagnosis of primary lung cancer 3. English speaking to enable engagement with the app and completion of study questionnaires 4. Able to provide written informed consent 5. Eastern Cooperative Oncology Group (ECOG) performance status ≤1 6. Has access to a smart device with secure internet connection |
| Key exclusion criteria | 1. A medical reason for the patient not to take part (e.g. other comorbidities, cognitive impairment) or not recommended by their responsible clinician 2. Requiring oxygen at rest or on exertion 3. Enrolled in another interventional clinical trial 4. ≤6 weeks following surgery for lung cancer 5. ≤6 weeks since last radiotherapy 6. Presence of brain or bone metastases 7. Falls risk using Falls Risk Assessment Tool (FRAT) ≤11 8. Rockwood frailty score ≤5 9. Active fever or infection 10. New angina or new cardiac problems 11. New blood clotting issue like a DVT or pulmonary embolism 12. Refused next cycle of chemotherapy or immunotherapy due to a low blood count 13. New shortness of breath at rest 14. Presence of open wounds 15. Recent epilepsy, blackouts, fainting or change in normal blood pressure readings 16. Dizziness or unsteadiness at rest or when standing 17. Nausea or vomiting or diarrhoea in the past 48 hours 18. Unusual sudden weakness 19. A change in vision or hearing 20. New persistent or severe headaches/migraines 21. New pain (new or recent bone, back or neck pain) |
| Date of first enrolment | 02/09/2024 |
| Date of final enrolment | 30/04/2025 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
Oxford
OX3 0BP
England
Southmead Road
Westbury-on-trym
Bristol
BS10 5NB
England
Headley Way
Headington
Oxford
OX3 9DU
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Editorial Notes
16/02/2026: Study's existence confirmed by the HRA Seasonal REC.
