Condition category
Cancer
Date applied
21/07/2020
Date assigned
31/07/2020
Last edited
05/08/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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 December 2021

Who is funding the study?
UK Research and Innovation

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

Trial website

https://www.cardiff.ac.uk/centre-for-trials-research/research/studies-and-trials/studies-and-trials-search

Contact information

Type

Scientific

Primary contact

Ms Yvonne Moriarty

ORCID ID

http://orcid.org/0000-0002-7608-4699

Contact details

Centre for Trials Research
4th floor Neuadd Meirrionydd
Heath Park
Cardiff
CF14 4YS
United Kingdom
+44 (0)2920687937
moriartyy@cardiff.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

COVID-19 cancer attitudes and behaviour study: a prospective mixed-methods cohort study

Acronym

CABS

Study hypothesis

To 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

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

Study design

Prospective mixed-methods cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Community

Trial type

Other

Patient information sheet

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

Condition

Cancer behaviour science in the general population

Intervention

Members 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 type

Other

Phase

Drug names

Primary outcome measure

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

Secondary outcome measures

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

Overall trial start date

30/06/2020

Overall trial end date

29/12/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Members of the public are eligible to take part if they are:
1. Aged over 18 years
2. Living in the UK

Participant type

All

Age group

Adult

Gender

Both

Target number of participants

3,535

Participant exclusion criteria

Members of the public are not eligible to take part if they are non-English speakers

Recruitment start date

05/08/2020

Recruitment end date

31/12/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

Cardiff University

Sponsor details

Main Building
Park Place
Cardiff
CF10 3AT
United Kingdom
+44 (0)29 2087 5834
resgov@cardiff.ac.uk

Sponsor type

University/education

Website

http://www.cardiff.ac.uk/

Funders

Funder type

Government

Funder name

UK Research and Innovation

Alternative name(s)

UKRI

Funding Body Type

private sector organisation

Funding Body Subtype

Other non-profit organizations

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Study documents are not currently available but will be made available on request. Exact details of the publication policy are still being developed. However, the researchers will provide rapid recommendations to drive tailored public health initiatives for cancer early detection and prevention in the pandemic recovery period. Longer-term, the study will lay the foundations for assessing policy impact in response to future global health threats.

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

31/12/2022

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

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