APPROACH: a mobile phone app to encourage increased health & wellbeing after cancer
| ISRCTN | ISRCTN14149329 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14149329 |
| IRAS number | 330862 |
| Secondary identifying numbers | CPMS 58274, IRAS 330862 |
- Submission date
- 06/09/2023
- Registration date
- 11/09/2023
- Last edited
- 20/01/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English Summary
Background and study aims
People living with and beyond cancer are at increased risk of many long-term consequences of cancer and its treatment, including fatigue, pain, sleep disturbance, anxiety and depression. Physical activity has many benefits after a cancer diagnosis, including reduction of these symptoms as well as reduced risk of cancer recurrence and mortality. Cancer patients have reported that they view walking as the type of physical activity they would be most likely to engage in. The aim of this study is to explore the clinical and cost-effectiveness of a smartphone app-based intervention (with additional support) that promotes brisk walking among those living with localised breast, prostate or colorectal cancer across hospital sites in Yorkshire. This is a potentially low-cost intervention which could be integrated into routine care and increase activity levels in this group and therefore improve their health and well-being.
Who can participate?
Men and women, aged over 16 years old, who are not currently meeting physical activity guidelines and have been diagnosed with breast, prostate or colorectal cancer at one of the recruiting NHS hospital sites in Yorkshire.
What does the study involve?
At the start of the study, participants will be asked to complete an online questionnaire about different aspects of their health, including their physical activity, quality of life, fatigue, sleep, anxiety and depression, their confidence about doing physical activity and managing their cancer, habit strength for walking and health and social care service use. They will also be asked to weigh and measure themselves and to wear a small device (an accelerometer) on their thigh for 7 days. This device measures the amount of time spent sitting, lying down, asleep and moving around. These measures will be repeated at 3 and 6 months after they are randomised. Participants will be randomly allocated to an intervention or control group. The control group will continue to receive their usual care. The intervention group will receive a leaflet about physical activity and cancer, guidance about how to download the app being recommended to participants (the app promotes and tracks brisk walking) and a walking planner. Intervention participants will also receive two behavioural support telephone/video calls, focusing on the benefits of brisk walking and how participants may use the app to increase their walking and resolve any problems downloading the app. Participants in the intervention group may also be invited to participate in an interview to tell the researchers what they thought about participating in the study and how they found using the app.
What are the possible benefits and risks of participating?
It is hoped that people in the intervention group may notice an improvement in their health or wellbeing, but at the moment it is unknown what effect the intervention will have (if any). Some people may find the study assessments (e.g. completing questionnaires, wearing the accelerometer device) inconvenient. The accelerometers are very small and are worn underneath clothes, so they are not visible. Wearing the device should not interfere with usual activities, but some people may find them uncomfortable.
Where is the study run from?
The study is run by University College London (UCL), with collaborators at the University of Leeds, Anglia Ruskin University, the University of Sheffield, Sheffield Teaching Hospitals NHS Foundation Trust and the recruiting hospital sites in the UK.
When is the study starting and how long is it expected to run for?
September 2022 to December 2025
Who is funding the study?
1. Yorkshire Cancer Research (UK)
2. National Institute for Health and Care Research (NIHR) (UK)
Who is the main contact?
1. Dr Fiona Kennedy, f.r.kennedy@leeds.ac.uk
2. Prof Abigail Fisher, abigail.fisher@ucl.ac.uk
Contact information
Scientific
Leeds Institute of Health Sciences
University of Leeds
Worsley Building, Level 10
Clarendon Way
Leeds
LS2 9NL
United Kingdom
 ORCID ID |
0000-0002-4910-2505 |
|---|---|
| Phone | +44 (0)113 3430813 |
| f.r.kennedy@leeds.ac.uk |
Principal Investigator
University College London
Gower Street
London
WC1E 6BT
United Kingdom
| ORCID ID |
0000-0001-9284-6780 |
|---|---|
| Phone | +44 (0)2076791722 |
| abigail.fisher@ucl.ac.uk |
Study information
| Study design | Randomized interventional process of care study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | ISRCTN14149329_PIS_v5.pdf |
| Scientific title | APPROACH: an app for health & wellbeing after cancer – a randomised controlled trial |
| Study acronym | APPROACH RCT |
| Study hypothesis | The primary research objective is to compare the effect of a theory-driven, app-based intervention that promotes brisk walking in addition to usual care and usual care, on activPAL-assessed average minutes of brisk walking (≥100 steps per minute) in adults living with breast, prostate or colorectal cancer after 3 months. The key secondary objectives are: 1. To compare the effect of a theory-driven, app-based intervention that promotes brisk walking in addition to usual care and usual care, in adults living with breast, prostate or colorectal cancer on: 1.1. activPAL-assessed average minutes of brisk walking (≥100 steps per minute) after 6 months 1.2. activPAL-assessed average total steps, minutes of light physical activity, standing time and sitting time at 3 and 6 months 1.3. Body Mass Index (BMI) at 3 and 6 months (self-reported) 1.4. Waist circumference at 3 and 6 months (self-reported) 1.5. Self-reported physical activity at 3 and 6 months 1.6. Health status, cancer-specific quality of life, fatigue, sleep quality, anxiety, depression, social support, self-efficacy to manage cancer and physical activity self-efficacy at 3 and 6 months 1.7. Habit strength for walking at 3 and 6 months 2. To assess the cost-effectiveness of a theory-driven, app-based intervention that promotes brisk walking in addition to usual care and usual care, in adults living with breast, prostate or colorectal cancer. |
| Ethics approval(s) |
Approved 03/10/2023, London-Surrey Research Ethics Committee (Meeting held by video-conference via Zoom, London, None available, United Kingdom; +44 (0)207 104 8088, (0)207 104 8131; surrey.rec@hra.nhs.uk), ref: 23/LO/0740 |
| Condition | Cancer |
| Intervention | Participants will be randomised into intervention or control groups using minimisation with a 1:1 allocation ratio. Stratification factors will be cancer type (breast, prostate or colorectal) and hospital location. The first participant will be randomly allocated, then each subsequent participant will be allocated based on the imbalance scores (calculated as a function of current allocations after a hypothetical allocation of the new participant in each study arm). The new participant will be allocated to the arm with the lowest imbalance score. A 20% random element will be included in the algorithm. Researchers collecting follow-up assessments and statisticians will be blind to group allocation. Control: Usual care Intervention: An app that promotes and tracks brisk walking. A leaflet that provides information on physical activity guidelines and promotes brisk walking and the use of the app. Two telephone calls with a researcher to provide behavioural support for increasing brisk walking and using the app. |
| Intervention type | Behavioural |
| Primary outcome measure | Daily average minutes of brisk walking (≥100 steps per minute) measured using an objective measure (an activPAL accelerometer), worn for 7 days at baseline, 3 and 6 months |
| Secondary outcome measures | 1. Average total steps, minutes of light physical activity, standing time and sitting time measured using an activPAL accelerometer at baseline, 3 and 6 months 2. Body Mass Index (BMI) self-reported using scales provided by the study at baseline, 3 and 6 months 3. Waist circumference self-reported using tape measure provided by the study at baseline, 3 and 6 months 4. Self-reported physical activity measured using the Godin Leisure Time Exercise Questionnaire (GLTEQ) at baseline, 3 and 6 months 5. Self-reported health status (using the five-level EuroQol-5D questionnaire,EQ-5D-5L), cancer-specific quality of life (using the Functional Assessment of Cancer Therapy-general, FACT-G), fatigue (FACT-F), sleep quality (Pittsburgh Sleep Quality Index, PSQI), anxiety (Generalised Anxiety Disorder Assessment, GAD-7), depression (Patient Health Questionnaire, PHQ-9), social support (brief form of the Perceived Social Support Questionnaire, F-Soz-UK-6), self-efficacy to manage cancer (Cancer Survivorship Self-Efficacy Scale, CS-SES) and physical activity self-efficacy (Physical Activity Appraisal Inventory, PAAI) at baseline, 3 and 6 months 6. Habit strength for walking measured using the Self-Report Behavioural Automaticity Index (SRBAI) at baseline, 3 and 6 months 7. App usage (in the intervention group) measured using questions from the Digital Behaviour Change Interventions Engagement Scale at 3 and 6 months 8. Health and social care service use measured using the Client Service Receipt Inventory (CSRI) at baseline, 3 and 6 months 9. Hospital service use measured using medical records over the 30 weeks after randomisation |
| Overall study start date | 01/09/2022 |
| Overall study end date | 31/12/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 472; UK Sample Size: 472 |
| Participant inclusion criteria | Note, points 1 and 2 are checked by the clinical care team in the initial medical record eligibility screening. 1. Diagnosed with breast, prostate or colorectal cancer within the last 2 and a half years at a participating hospital site 2. Aged 16 years or older 3. Own a smartphone (that uses Android or iOS (Apple) operating systems) 4. Willing and able to provide informed consent 5. Has access to a computer or tablet and an email address, and is willing to complete online questionnaires. 6. Willing to wear an accelerometer for a week at the assessment points |
| Participant exclusion criteria | Note, points 1a, 4, 5, 6 and 13 are checked by the clinical care team in the initial medical record eligibility screening. 1. Patients who are more than 2 years post-diagnosis at the point of screening by hospital staff. Due to the potential time gap between screening/inviting participants and then consenting we will exclude patients who are more than 2 and a half years post-diagnosis at consent. 2. Unable to understand spoken/written English 3. ECOG status > 3 4. Diagnosed cognitive impairment (e.g. dementia) 5. Cognitive and/or physical impairment that prevents participation in brisk walking 6. Those who have a current diagnosis of metastatic disease 7. Due to have surgery to remove cancer in the next 5 months 8. < 6 weeks after surgery to remove cancer at consent 9. Reports achieving 150 minutes of at least moderate intensity PA weekly [80] 10. Report previous/current use of the study app app 11. Current participation in a health behaviour change study 12. Live with someone already participating in the trial 13. Incarcerated (i.e. address is a prison) 14. Already participated in the APPROACH pilot study (only applies at the pilot hospital site) |
| Recruitment start date | 23/10/2023 |
| Recruitment end date | 31/05/2025 |
Locations
Countries of recruitment
- United Kingdom
Study participating centres
Doncaster
DN2 5LT
United Kingdom
Sheffield
S5 7AU
United Kingdom
Leeds
LS9 7TF
United Kingdom
Barnsley
S75 2EP
United Kingdom
Wakefield
WF1 4DG
United Kingdom
Acre Street
Lindley
Huddersfield
HD3 3EA
United Kingdom
Gower Street
London
WC1E 6BT
United Kingdom
Worsley Building, Woodhouse
Leeds
LS2 9TU
United Kingdom
Rotherham
S60 2UD
United Kingdom
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom
Sponsor information
Hospital/treatment centre
UCLH/UCL Joint Research Office
4th Floor, West
250 Euston Road
London
NW1 2PG
England
United Kingdom
| Phone | +44 (0)20 7679 2000 |
|---|---|
| uclh.randd@nhs.net | |
| Website | http://www.ucl.ac.uk/ |
"ROR" |
https://ror.org/02jx3x895 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Government organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- YCR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a publicly available repository. At the end of the trial, a dataset that is functionally anonymous in the hands of the public (ID number and hospital site removed and date of birth translated into an age bracket for the age of the participant on the date of randomisation) will be shared publicly on Open Science Framework. This has been approved by UCLs Data Protection Officer. 12 years after the end of the trial all identifiable information will deleted and the data will remain available on the Open Science Framework. The consent form states “I understand that information collected about me may be used to support other research in the future, and may be shared anonymously with other researchers. I will not be identified.” |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 5 | 17/10/2023 | No | Yes |
Additional files
Editorial Notes
20/01/2025: The following changes were made to the study record:
1. The recruitment end date was changed from 31/01/2025 to 31/05/2025.
2. The overall study end date was changed from 31/05/2025 to 31/12/2025.
3. The intention to publish date was changed from 31/10/2026 to 31/12/2026.
4. Bradford Teaching Hospitals NHS Foundation Trust was added to the study participating centres.
25/07/2024: The study participating centre Rotherham District General Hospital was added.
17/10/2023: Participant information sheet uploaded.
16/10/2023: Ethics approval details added. The recruitment start date was changed from 30/09/2023 to 23/10/2023.
06/09/2023: Study's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
