Submission date
05/06/2020
Registration date
09/06/2020
Last edited
19/07/2023
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Not Applicable
Retrospectively registered
? Protocol not yet added
? SAP not yet added
Results added
? Raw data not yet added
Study completed

Plain English Summary

Background and study aims
There is lots of information about e-cigarettes online, especially on social media. This type of information may be hindering efforts to reduce tobacco smoking and in turn result in more cases of cancer. Researchers would like to find out how information about e-cigarettes impacts on people’s attitudes towards using e-cigarettes. They have created a questionnaire designed to find out what people think about e-cigarettes after seeing different types of information about e-cigarettes.

Who can participate?
Current smokers aged 18 years or older, living in the US or the UK who do not currently use e-cigarettes or a vaping device.

What does the study involve?
Participants are asked to complete an online questionnaire about e-cigarette use. Participants are then shown some information related to the health impacts of e-cigarettes on separate screens. Following the information messages, they are then asked to complete a second questionnaire about e-cigarette use.

What are the possible benefits and risks of participating?
There are no risks associated with taking part in this study. The researchers added a debrief summary of the latest evidence relating to the relative/absolute harms of e-cigarettes and also provided a link to stopping smoking services in their region. The results from this study will help researchers to better understand how information impacts on people’s beliefs about e-cigarettes/vapes, which in turn could help with smoking cessation programmes and reduce cancer.

Where is the study run from?
University of Bristol (UK)

When is the study starting and how long is it expected to run for?
March 2019 to December 2019

Who is funding the study?
Cancer Research UK

Who is the main contact?
Dr Caroline Wright
caroline.wright@bristol.ac.uk

Study website

Contact information

Type

Scientific

Contact name

Dr Caroline Wright

ORCID ID

http://orcid.org/0000-0002-4321-4872

Contact details

Population Health Sciences
Bristol Medical School
University of Bristol
BF4
Barley House
Oakfield Grove
Bristol
BS8 2BN
United Kingdom
+44 (0)117 3314011
caroline.wright@bristol.ac.uk

Additional identifiers

EudraCT/CTIS number

Nil known

IRAS number

ClinicalTrials.gov number

Nil known

Protocol/serial number

CRUK28664

Study information

Scientific title

Examining prevalence, mechanism of action and effects of e-cigarette misinformation on Twitter

Acronym

Study hypothesis

Exposure to misinformation about e-cigarette harms on Twitter among current smokers in the United States (US) and the United Kingdom (UK) will result in increased misperceptions of e-cigarette harms.

Ethics approval(s)

Approved 05/08/2019, additional amendment approved 11/12/2019, further amendment approved 30/04/2020, University of Bristol Faculty of Health Sciences Research Ethics Committee (FREC, University of Bristol Faculty of Health Sciences, First Floor South, Senate House, Tyndall Avenue, Bristol, BS8 1TH, UK; +44 (0)117 331 8197, +44 (0)117 928 9089; Liam.McKervey@bristol.ac.uk), ref: 80323

Study design

Randomized controlled experiment using an online survey instrument

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Study setting(s)

Internet/virtual

Study type

Prevention

Patient information sheet

See attached file

Condition

Prevention of cancer through smoking cessation

Intervention

Following eligibility screening and providing informed consent, participants first complete baseline measures of study outcomes. Participants are randomized into one of four experimental conditions in a 1:1:1:1 ratio using the in-built least-fill randomiser function on the Prodege survey platform:
1. Messages that e-cigarettes are as or more harmful than regular cigarettes
2. Messages that e-cigarettes are completely harmless
3. Messages conveying uncertainty about e-cigarettes
4. Control: messages about physical activity

Participants are told they would be shown different types of health-related information and asked about their opinions about e-cigarettes. After randomization to a condition, they view one tweet at a time in random order and are asked brief questions (perceived effectiveness, liking and sharing, and their emotions) about each tweet. They next complete post-test measures of the study outcomes, current tobacco use behaviours, health information exposure and (social) media use, and socio-demographic and psychological characteristics.

Intervention type

Behavioural

Primary outcome measure

Measured pre-exposure (baseline) and post-exposure:
1. Smoking cessation contemplation ladder: participants provide a score reflecting their likelihood of quitting smoking from 0 (no thought of quitting) to 10 (taking action to quit)
2. Risk perceptions of combustible tobacco: participants were asked to give a score reflecting the likelihood that smoking combustible tobacco will result in lung cancer, heart disease, mouth or throat cancer, chronic obstructive pulmonary disorder (COPD) and stroke from 1 (extremely unlikely) to 5 (extremely likely)
3. Risk perceptions of electronic cigarettes: participants were asked to give a score reflecting the likelihood that smoking combustible tobacco will result in lung cancer, heart disease, mouth or throat cancer, chronic obstructive pulmonary disorder (COPD) and stroke from 1 (extremely unlikely) to 5 (extremely likely)
4. Perceived relative harm of e-cigarettes compared to smoking regular cigarettes: participants were asked: Compared to smoking regular cigarettes, would you say that e-cigarettes/vapes are much less harmful (1) - much more harmful (5).
5. Intentions to purchase electronic cigarettes in the next month: How probable is it that you will purchase an e-cigarette/vape in the next month? 0 (no chance) to 10 (certain)
6. Knowledge about electronic cigarettes: participants’ given statement about e-cigarettes e.g. E-cigarettes do not contain any of the toxic chemicals that can be found in regular cigarettes and asked if the statement is (1) true, (20) false, or (3) don’t know.

Secondary outcome measures

1. Perceived effectiveness of exposure condition: participants' were asked after viewing each exposure to rate how much they disagree or agree with the following statements about the message they just saw: this message is worth remembering, this message grabbed my attention, this message is powerful, this message is informative, this message is meaningful to me, this message is convincing.
2. Intentions to reply/retweet/like/share message (Tweets): participants were asked after each exposure are you likely to reply/retweet/like/share this message.
3. Emotional responses to exposure condition: participants were asked after each exposure: when thinking about e-cigarettes, does the message you just saw make you feel: scared, hopeful, worried, happy, angry, relieved
4. Self-efficacy to quit smoking, participants were asked at the end of the questionnaire: How confident are you that you can quit using tobacco? Not at all confident, Not very confident , Somewhat confident , Confident , Very confident & Completely confident
5. Prior exposure to e-cigarette misinformation, participants were asked at the end of the questionnaire
6. Level of trust for information on e-cigarettes: participants were asked at the end of the questionnaire
7. Exposure to conflicting information about e-cigarettes: participants were asked at the end of the questionnaire
8. Information seeking about e-cigarettes: participants were asked at the end of the questionnaire
9. Perceived addictiveness of cigarettes and e-cigarettes: participants were asked at the end of the questionnaire
10. Social media and internet use: participants were asked at the end of the questionnaire
11. Self-identity; participants were asked: How much do you agree or disagree with each of the following statements: I am very sensitive to criticism by others. Answers: strongly disagree (1) - strongly agree (5). Measured once, post-exposure.
12. Epistemic beliefs about facts and science: participants' were asked a series of questions about their intuition, need to see evidence and beliefs about how truth/facts and power/politics interact. Measured once, post-exposure.

Overall study start date

01/03/2019

Overall study end date

05/12/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Participants’ must be current smokers
2. Aged 18 years or older
3. Living in either the US or UK
4. Who are not currently using e-cigarettes or a vaping device

Participant type(s)

Other

Age group

Adult

Lower age limit

18 Years

Sex

Both

Target number of participants

2400

Total final enrolment

2400

Participant exclusion criteria

1. Not aged 18 years or older
2. Did not live in either the US or UK
3. Were not current smokers
4. Were currently using e-cigarettes or vaping device

Recruitment start date

08/11/2019

Recruitment end date

28/11/2019

Locations

Countries of recruitment

England, United Kingdom

Study participating centre

University of Bristol
Bristol Medical School
Barley House
Oakfield Grove
Bristol
BS8 2BN
United Kingdom

Sponsor information

Organisation

University of Bristol

Sponsor details

University of Bristol Faculty of Health Sciences
First Floor South
Senate House
Tyndall Avenue
Bristol
BS8 1TH
England
United Kingdom
+44 (0)117 928 9089
Liam.McKervey@bristol.ac.uk

Sponsor type

University/education

Website

http://www.bristol.ac.uk/red/research-governance/ethics/uni-ethics/

ROR

https://ror.org/0524sp257

Funders

Funder type

Charity

Funder name

Cancer Research UK

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

Other non-profit organizations

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publications in high impact journals.

Intention to publish date

01/09/2020

Individual participant data (IPD) sharing plan

Following the completion of the research and subsequent publications, instructions for accessing the data will be made available on Dr Caroline Wright's homepage on the University of Bristol website (and CRUK website if requested).
Requests for data will be fielded by Dr Caroline Wright (caroline.wright@bristol.ac.uk) and shared with other researchers, provided a satisfactory data-sharing agreement has been completed by the requesting researcher. The data-sharing agreement will impose appropriate limitations on the secondary use of the data, with reference to the 'Samples and Data for Cancer Research: Template for Access Policy Development' document. The researchers also plan to upload the data to a data repository site.

IPD sharing plan summary

Available on request

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 01/09/2021 13/09/2021 Yes No
Results article 21/12/2021 22/12/2021 Yes No
Results article 24/11/2022 19/07/2023 Yes No

Additional files

Editorial Notes

19/07/2023: Publication reference added. 22/12/2021: Publication reference added. 13/09/2021: Publication reference added. 03/07/2020: The participant information sheet has been uploaded. 08/06/2020: Trial's existence confirmed by Cancer Research UK.