ISRCTN ISRCTN17782018
DOI https://doi.org/10.1186/ISRCTN17782018
ClinicalTrials.gov (NCT) Nil known
Clinical Trials Information System (CTIS) Nil known
Protocol serial number Nil known
Sponsor Cardiff University
Funder UK Research and Innovation
Submission date
21/07/2020
Registration date
31/07/2020
Last edited
30/12/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
During the COVID-19 pandemic, people may not be aware of the importance of seeking early medical help for signs of cancer or taking up screening, when available, to diagnose cancer sooner. In addition, some people may not want to be referred to a hospital for diagnostic tests due to fear of catching coronavirus in the healthcare setting. COVID-19 may also affect whether people take part in healthy behaviours that can reduce the chances of getting cancer. These factors may lead to more cancers occurring, and more cancers being diagnosed at a late stage when treatment may be less successful.
The researchers want to understand how people are thinking about getting help from doctors at the moment. Due to the coronavirus pandemic, the numbers of people visiting their GP with potentially serious symptoms have reduced dramatically. The researchers are concerned that people may not be aware of the importance of seeking medical help if they notice any changes in their body or health. They also want to understand how coronavirus may affect whether people take part in health behaviours.

Who can participate?
Adults aged 18+ who live across the UK. The aim is to include adults from a range of different backgrounds including people from a Black, Asian or minority ethnic background and those who live in disadvantaged communities as data suggests that they may have been more affected by coronavirus than other groups.

What does the study involve?
Working closely with Cancer Research UK, the researchers will carry out an online survey with at least 3,500 people to ask about any recent symptoms, cancer screening and health behaviours during the UK lockdown period. Survey questions will include the delay in visiting the GP with a range of possible cancer symptoms, attitudes to cancer screening and anxiety about seeking help in the current situation. Other barriers to seeking help will be explored together with health behaviours including smoking, alcohol, diet and physical activity. People will also be asked how they would prefer to receive public health information. Each survey will take about 15-20 minutes to complete. The researchers will ask people to provide some personal information (e.g. name, date of birth and address). They would like to use these details to be able to link peoples responses with routinely collected health service data which already exist (e.g. admissions to hospital or contact with your GP). They will also interview by telephone around 30 people who have taken part in the survey to understand their attitudes and behaviours in more detail. The survey and interviews will be repeated with the same people around six months later, to assess any changes in their views and information preferences.

What are the possible benefits and risks of participating?
There will be no direct advantages or benefits to people from taking part. However, THE participants' contribution will help the researchers to understand the impact of coronavirus on health and health behaviours. The results will help them work with the NHS, public health services and charities to reduce the negative impact of coronavirus in the future.

Where is the study run from?
Cardiff University (UK)

When is the study starting and how long is it expected to run for?
June 2020 to March 2022

Who is funding the study?
UK Research and Innovation

Who is the main contact?
Yvonne Moriarty
MoriartyY@cardiff.ac.uk

Contact information

Ms Yvonne Moriarty
Scientific

Centre for Trials Research
4th floor Neuadd Meirrionydd
Heath Park
Cardiff
CF14 4YS
United Kingdom

ORCiD logoORCID ID 0000-0002-7608-4699
Phone +44 (0)2920687937
Email moriartyy@cardiff.ac.uk

Study information

Primary study designObservational
Study designProspective mixed-methods cohort study
Secondary study designCohort study
Study type Participant information sheet
Scientific titleCOVID-19 cancer attitudes and behaviour study: a prospective mixed-methods cohort study
Study acronymCABS
Study objectivesTo generate rapid evidence-based on public views/response, informing public health interventions to encourage timely symptom presentation, screening engagement and cancer-related health behaviours in the wake of the pandemic.
Ethics approval(s)Approved 29/07/2020, Cardiff University School of Medicine Ethics Committee (Cardiff University School of Medicine, College of Biomedical and Life Sciences, Heath Park, Cardiff, CF14 4XN, UK; no telephone number provided; EvansCR9@cardiff.ac.uk), ref: none provided
Health condition(s) or problem(s) studiedCancer behaviour science in the general population
InterventionMembers of the public will be invited to complete an online survey to ask about any recent symptoms, cancer screening and health behaviours during the COVID-19 pandemic. Survey questions will include the delay in visiting the GP with a range of possible cancer symptoms, attitudes to cancer screening and anxiety about seeking help in the current situation. Other barriers to seeking help will be explored together with health behaviours including smoking, alcohol, diet and physical activity. People will also be asked how they would prefer to receive public health information.

The researchers will also interview by telephone around 30 people who have taken part in the survey to understand their attitudes and behaviours in more detail. The survey and interviews will be repeated with the same people around 6 months later to assess any changes in their views and information preferences.

Finally, the researchers will link the survey data with medical records available in Wales to assess the number of GP referrals and tests for suspected cancer symptoms, whether people have taken part in cancer screening, whether people who smoke have quit, and the number and stage of new cancers diagnosed.
Intervention typeOther
Primary outcome measure(s)

Self-reported time to presentation in those who have experienced a potential cancer symptom measured using online survey at baseline and 6 months

Key secondary outcome measure(s)

1. Anticipated time to presentation with hypothetical cancer symptoms measured using online survey at baseline and 6 months
2. Cancer screening intentions measured using online survey at baseline and 6 months
3. Health behaviours – smoking, alcohol, diet, exercise measured using online survey at baseline and 6 months

Completion date31/03/2022

Eligibility

Participant type(s)All
Age groupAdult
Lower age limit18 Years
SexAll
Target sample size at registration3535
Total final enrolment7543
Key inclusion criteriaMembers of the public are eligible to take part if they are:
1. Aged over 18 years
2. Living in the UK
Key exclusion criteriaMembers of the public are not eligible to take part if they are non-English speakers
Date of first enrolment05/08/2020
Date of final enrolment31/12/2020

Locations

Countries of recruitment

  • United Kingdom
  • Wales

Study participating centre

Centre for Trials Research
Neuadd Meirrionydd
Heath Park
Cardiff
CF14 4YS
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
IPD sharing planThe data sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Cancer symptom experience and help-seeking behaviour 16/09/2021 21/09/2021 Yes No
Results article cancer screening intentions 01/12/2021 30/12/2021 Yes No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes
Study website Study website 11/11/2025 11/11/2025 No Yes

Editorial Notes

30/12/2021: The following changes have been made:
1. Publication reference added.
2. The overall trial end date has been changed from 29/12/2021 to 31/03/2022 and the plain English summary updated accordingly.
21/09/2021: Publication reference added.
12/03/2021: The total final enrolment number has been added.
05/08/2020: The following changes were made to the trial record:
1. The ethics approval was added.
2. The recruitment start date was changed from 04/08/2020 to 05/08/2020.
21/07/2020: Trial’s existence confirmed by Economic and Social Research Council