Improving Awareness and Beliefs About Cancer (ABACus) symptoms by using a bespoke online cancer health check interactive tool with personally tailored advice regarding lifestyle risk factors from a trained lay advisor
| ISRCTN | ISRCTN16872545 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16872545 |
| Secondary identifying numbers | 36714 |
- Submission date
- 27/11/2017
- Registration date
- 12/01/2018
- Last edited
- 24/02/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English Summary
Background and study aims
Evidence shows that cancer survival rates are lower in disadvantaged communities, possibly due to low awareness of symptoms and delayed help-seeking. It is important that people increase their knowledge of cancer symptoms, so that they know when to go seek medical advice about their concerns, and therefore possibly detecting cancer earlier, which will improve their outlook. We have developed an interactive online health check questionnaire to be delivered in these communities by trained advisors which is designed to help people recognise possible cancer signs early. The health check is a short questionnaire completed on an iPad with the help of a trained advisor. There are 29 questions which ask participants about their background, lifestyle and health. They are then given a summary page at the end which colour codes their responses using a traffic light system (red, amber, green) to highlight areas where action and or advice should be taken. There is already some research to test what people think about the health check. Based on this changes have been made to improve it. The aim of this study is to see if the health check increases people’s knowledge of cancer signs and lifestyle risks and to see if increased knowledge encourages people to ask for help earlier.
Who can participate?
Adults aged 40 and older who live in a socioeconomically deprived areas of South and West Yorkshire (UK).
What does the study involve?
Participants are asked to complete a questionnaire on an iPad. This can be done by themselves or with the help of an advisor. It will ask about their knowledge of cancer symptoms and cancer lifestyle risks. It will also ask some background information about them. This will take around 20 minutes. Participants are then randomly allocated to one of two groups. Participants who are allocated to the first group do not do anything else on the day. Participants allocated to the second group are then asked to complete the online health check with the help of an advisor. Their results are summarised at the end on a single page. A red, amber, green traffic light system are used to show their results and the advisor will discuss their results with them. This takes around 25 minutes. Some sessions are recorded or observed. All participants are contacted again in two weeks and six months’ time to complete the questionnaire again. This is done on the telephone. In addition to the main study, some of the participants (around 45-50) are asked if they want to take part in an interview with one of the researchers. Interviews either takes place after the two week or six month questionnaire and lasts around 30 minutes. Participants are asked about their experiences of taking part and if they have any experiences of wider cancer awareness campaigns.
What are the possible benefits and risks of participating?
Participants will be providing important information about what people know and think about cancer symptoms. The questionnaires will help us test if the online health check improves people’s knowledge of cancer symptoms and cancer-related lifestyle risks. Those participants who are in the treatment group will also receive a one page summary of their health check results. Participants also receive high street shopping vouchers for completing the study. There is no direct risk to taking part in this trial, however, some people don’t like talking about cancer or find talking about cancer upsetting. If participants get upset they can talk directly to the advisor or contact local services for support, which are listed on the information booklet.
Where is the study run from?
The study is being coordinated by the Centre for Trials Research (CTR) in Cardiff University (UK).
When is the study starting and how long is it expected to run for?
May 2017 to August 2020
Who is funding the study?
Yorkshire Cancer Research (UK)
Who is the main contact?
Ms Yvonne Moriarty (Scientific)
abacus@cardiff.ac.uk
Contact information
Scientific
Centre for Trials Research
College of Biomedical & Life Science
Cardiff University
4th floor Neuadd Meirionnydd
Heath Park
Cardiff
CF14 4YS
United Kingdom
Study information
| Study design | Randomised; Interventional; Design type: Not Specified, Not Specified |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Awareness and Beliefs About Cancer phase 3 (ABACus 3): Randomised controlled trial of a health check intervention to improve cancer symptom awareness and help-seeking among people living in socioeconomically deprived communities |
| Study acronym | ABACus 3 |
| Study hypothesis | The aim of this study is to undertake a phase 3 randomised controlled trial of the ABACus Health Check (previously developed and tested for feasibility/acceptability) as a means of improving cancer symptom awareness and help-seeking behaviour among adults living in socioeconomically deprived communities. |
| Ethics approval(s) | London Surrey NHS Research Ethics Committee, 12/10/2017, ref: 17/LO/1507 |
| Condition | Specialty: Cancer, Primary sub-specialty: Primary Care; UKCRC code/ Disease: Cancer/ Neoplasms of uncertain or unknown behaviour |
| Intervention | The ABACus Health Check is an innovative community outreach intervention designed to improve cancer symptom knowledge, encourage positive beliefs in relation to cancer early detection, and increase motivation to seek help among adults (aged 40 years and older) living in deprived communities. The health check has been informed by a theoretical understanding of the barriers and enablers to timely help-seeking among people living in disadvantaged communities, and comprises an interactive touchscreen questionnaire with behavioural support delivered face-to-face by a trained advisor, taking around 35 – 45 minutes to complete. The intervention is primarily designed to reduce the “patient interval”, defined as the time between appraising a bodily change as a potential symptom of cancer and presenting in primary care, but also attempts to synergise cancer screening and early symptom detection by including cancer symptom content and screening messages. Individualised results are provided in a traffic light system, with ‘green’ indicating results where no signposting or change is suggested, ‘amber’ indicating an area where signposting or change could be considered, and ‘red’ results indicating that action should be taken. Results can be printed on a one page summary format for participants to take away. Information and signposting to relevant services (for example, General Practitioner, stop smoking and weight loss services) are provided based on individual results. Participants are recruited from community (i.e. local groups) and health (i.e. GP surgeries) settings and randomised to either intervention (online health check) or control (usual available care/support) on a 1:1 ratio. Quantitative data is collected at baseline, two weeks and six months post randomisation. Measured used include: Adapted Awareness and Beliefs about Cancer measure (ABC), 6-item State-Trait Anxiety Inventory (STAI-6), Lifestyle using Theory of Planed Behaviour, self-rated health, screening behaviour, Client Service Receipt Inventory, Demographics, Contact Details and Recruitment Information (setting type etc). The primary analysis will predict follow-up cancer symptom recognition at 2 weeks using baseline cancer symptom recognition as well as key demographic variables in a linear analysis of covariance model (ANCOVA). All participants receive a total of £15 high street shopping vouchers (£10 at baseline and £5 at six months) as a thank you for taking part. Qualitative data supports the process evaluation and includes: interviews with lay advisors (n=3) pre and post-delivery, audio recordings/observations (n=24-25/n=12-13) of health check delivery sessions, interviews with participants at 2-4 weeks post randomisation (n=30), interviews with participants post 6 months (n=15-20). All participants who take part in an interview additionally receive £10 as a thank you for completing an interview). |
| Intervention type | Other |
| Primary outcome measure | Cancer symptom knowledge (calculated as the mean aggregated symptom recognition score), measured using the adapted (Awareness and Beliefs about Cancer) measure at 2 weeks. |
| Secondary outcome measures | 1. Cancer Beliefs, measured using the adapted ABC measure at 2 weeks and 6 months 2. Barriers to presentation, measured using the adapted ABC measure at 2 weeks and 6 months 3. Help-seeking intentions, measured using the adapted ABC measure at 2 weeks and 6 months 4. Cancer worry, measured using the State Trait Anxiety Inventory (STAI) measure at 2 weeks and 6 months 5. Intervention implementation costs, measured using the Client Service Receipt Inventory at 6 months Exploratory outcomes measures: 1. Cancer screening intentions, beliefs and self-reported behaviours measured using the Theory of Planned Behaviour Questionnaire at 2 weeks and 6 months 2. Lifestyle intentions (stop smoking, weight loss, reduce alcohol consumption), measured using the Theory of Planned Behaviour Questionnaire at 2 weeks and 6 months 3. Cancer risk factor awareness, measured using the adapted ABC at 2 weeks and 6 months |
| Overall study start date | 31/05/2017 |
| Overall study end date | 31/08/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 246; UK Sample Size: 246 |
| Total final enrolment | 234 |
| Participant inclusion criteria | 1. Aged 40 years and over 2. Recruited from socioeconomically deprived areas of South and West Yorkshire (i.e. Sheffield, Barnsley, Rotherham, Wakefield) or Southeast Wales (i.e. Merthyr Tydfil and Newport) |
| Participant exclusion criteria | 1. Non-English speakers 2. Unable to give informed consent 3. A participant from the phase 2 feasibility study (only relevant in South East Wales) |
| Recruitment start date | 07/12/2017 |
| Recruitment end date | 31/01/2019 |
Locations
Countries of recruitment
- England
- United Kingdom
- Wales
Study participating centres
Royal Glamorgan Hospital
Ynysmaerdy
Rhondda Cynon Taf
Llantrisant
CF72 8XR
United Kingdom
Aneurin Bevan University Health Board
Clinical Research and Innovation Centre
St Woolos Hospital
Newport
NP20 4SZ
United Kingdom
Bowling Old Lane
Bradford
BD5 7JR
United Kingdom
Sheffield Health & Social Care FT
Fulwood House
Old Fulwood Road
Sheffield
S10 3HT
United Kingdom
Sponsor information
Hospital/treatment centre
-
Cardiff
CF10 3AT
Wales
United Kingdom
"ROR" |
https://ror.org/03kk7td41 |
|---|
Funders
Funder type
Government
Government organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- YCR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/01/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Exact details of the publication policy are still being developed. However, broadly the researchers plan on publishing a protocol paper in a high impact paper once they are into recruitment (2018/2019) and the main trial results in a high-impact paper at the end of the trial (post-2020). |
| IPD sharing plan | The datasets generated during the current study will be available upon request from the study manager Yvonne Moriarty (Moriartyy@cardiff.ac.uk) with an agreed/signed data-sharing agreement. De-identified participant data will be made available to the scientific community with as few restrictions as feasible, whilst retaining exclusive use until the publication of major outputs. Cardiff University holds data for 15 years. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 11/03/2019 | 15/03/2019 | Yes | No |
| Results article | 27/08/2021 | 01/09/2021 | Yes | No | |
| Other publications | 04/11/2020 | 24/02/2023 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
24/02/2023: Publication reference added.
01/09/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
24/07/2020: IPD sharing statement added.
23/07/2020: The overall trial end date was changed from 30/04/2020 to 31/08/2020.
15/03/2019: Publication reference added.
11/12/2018: The recruitment start date was changed from 01/11/2017 to 07/12/2017.
29/10/2018: The following changes were made:
1. The recruitment end date was updated from 31/10/2018 to 31/01/2019.
2. The overall trial end date was updated from 30/10/2019 to 30/04/2020.
12/01/2018: The ISRCTN prospective/retrospective flag compares the date of registration with the recruitment start date and does not include any grace period. The registration of this study was requested through the NIHR Portfolio and was finalised within 6 months of the recruitment starting.
