Condition category
Cancer
Date applied
27/11/2017
Date assigned
12/01/2018
Last edited
12/01/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 are 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 co-ordinated 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 October 2019

Who is funding the study?
Yorkshire Cancer Research (UK)

Who is the main contact?
Ms Yvonne Moriarty (Scientific)
abacus@cardiff.ac.uk

Trial website

http://www.cardiff.ac.uk/centre-for-trials-research/research/studies-and-trials/view/abacus

Contact information

Type

Scientific

Primary contact

Ms Yvonne Moriarty

ORCID ID

Contact details

Centre for Trials Research
College of Biomedical & Life Science
Cardiff University
4th floor Neuadd Meirionnydd
Heath Park
Cardiff
CF14 4YS
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

36714

Study information

Scientific title

Awareness and Beliefs About Cancer phase 3 (ABACus 3): Randomised controlled trial of the health check intervention to improve cancer symptom awareness and help-seeking among people living in socioeconomically deprived communities

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

London Surrey NHS Research Ethics Committee, 12/10/2017, ref: 17/LO/1507

Study design

Randomised; Interventional; Design type: Not Specified, Not Specified

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Drug names

Primary outcome measures

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 trial start date

31/05/2017

Overall trial end date

30/10/2019

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 246; UK Sample Size: 246

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

01/11/2017

Recruitment end date

31/10/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Cwm Taf University Health Board R&D
Research & Development Department Royal Glamorgan Hospital Ynysmaerdy Rhondda Cynon Taf
Llantrisant
CF72 8XR
United Kingdom

Trial participating centre

Aneurin Bevan University Health Board R&D
Research & Development Office Aneurin Bevan University Health Board Clinical Research and Innovation Centre St Woolos Hospital
Newport
NP20 4SZ
United Kingdom

Trial participating centre

West Yorkshire R&D
Douglas Mills Bowling Old Lane
Bradford
BD5 7JR
United Kingdom

Trial participating centre

South Yorkshire R&D
Research & Development Unit Sheffield Health & Social Care FT Fulwood House Old Fulwood Road
Sheffield
S10 3HT
United Kingdom

Sponsor information

Organisation

Cardiff University

Sponsor details

-
Cardiff
CF10 3AT
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Yorkshire Cancer Research

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Exact details of our publication policy is still being developed. However, broadly we plan on publishing a protocol paper in a high impact paper once we 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 statement:
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/01/2021

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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.