Condition category
Cancer
Date applied
11/10/2012
Date assigned
08/11/2012
Last edited
25/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Prof Ronan O'Carroll

ORCID ID

Contact details

University of Stirling
Division of Psychology
School of Natural Sciences
Stirling
FK9 4LA
United Kingdom
-
reo1@stir.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A randomised controlled trial of a brief psychological intervention to increase the uptake of colorectal cancer screening in adults aged 50-74 years in Scotland

Acronym

ARTICS

Study hypothesis

In this large-scale, questionnaire-based study we will test whether asking people whether they would later regret not returning their Faecal Occult Blood Test (FOBT) screening kit for colorectal cancer increases FOBT returns.

Research questions:
1. Does a brief, theory-based anticipated regret (AR) intervention lead to a significant increase in the uptake of FOBT colorectal cancer screening in Scotland?
2. Is the effect observed equally across genders and social deprivation levels?
3. Is the effect a general consequence of the 'mere measurement effect' (i.e. completing a questionnaire about the topic in question may increase response) or is it a specific consequence of AR?
4. Is uptake influenced by participants' health beliefs, in particular anticipated regret, disgust, intention, perceived benefit and health locus of control?

Ethics approval

Not provided at time of registration

Study design

Three-armed prospective randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

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

Condition

Colorectal bowel cancer screening

Intervention

We will adopt a simple, between-groups, three-arm prospective randomised controlled trial design:
1. Control: no questionnaire
2. HLOC: Health Locus of Control questionnaire
3. AR: Anticipated regret questionnaire
Participants who are allocated to the questionnaire arms (2 & 3) will be told that we are studying the effects of attitudes towards screening, and how they influence FOBT returns.

Control arm
Participants in the control arm will be sent the standard pre-notification letter, according to current practice.

HLOC Intervention
Those randomly allocated to the HLOC group will also be sent the pre-notification letter plus the 18-item Health Locus of Control scale. HLOC participants will also be asked to rate their perceived disgust (ick factor) and perceived benefit of returning their FOBT using modified versions of the ick-factor scale and perceived benefit scales from our previous research with organ donation, as well as rating their intention of returning the FOBT test, all using simple scales. Participants will be asked to return this brief questionnaire in a stamped addressed envelope that will be provided. We predict that high scores on chance HLOC will predict lower return rates, as this taps a fatalistic view of health and health outcomes.

AR Intervention
Those allocated to the AR group will also be sent the pre-notification letter and will be asked to complete the same HLOC/ick/perceived benefit questionnaire as the HLOC group with 2 additional AR questions. The first of these additional questions will be placed as the very first question of the survey ('If I did not complete and return my test kit I would later feel regret') and the second will be placed immediately preceding the final question measuring intention to return the kit ('If I did not complete and return my test kit, I would later wish I had'). In order to make the two questionnaires identical in length, the HLOC questionnaire will have 2 filler questions added in the same location as the AR questions.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Return of the completed FOBT test kit to the central laboratory at the Scottish Bowel Screening Centre, within 6 months of the kit being sent out.

Secondary outcome measures

1. Health Locus of Control Scale
2. Perceived disgust (ick factor)
3. Perceived benefit of returning the FOBT kit
4. Intention to return the FOBT test

Overall trial start date

01/10/2012

Overall trial end date

31/05/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Members of the Scottish general public who are invited to participate in the national colorectal cancer screening programme
2. Aged between 50 and 74 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60,000 individuals, randomised to 3 arms (20,000 in each arm)

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/10/2012

Recruitment end date

31/05/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Stirling
Stirling
FK9 4LA
United Kingdom

Sponsor information

Organisation

University of Stirling (UK)

Sponsor details

c/o Carol Johnstone
Research and Enterprise Office
Stirling
FK9 4LA
United Kingdom
-
carol.johnstone@stir.ac.uk

Sponsor type

University/education

Website

http://www.stir.ac.uk/

Funders

Funder type

Government

Funder name

Chief Scientist Office of the Scottish Executive Health Department (UK) ref: CZH/4/793

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24041309
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26301484

Publication citations

  1. Protocol

    O'Carroll RE, Steele RJ, Libby G, Brownlee L, Chambers JA, Anticipated regret to increase uptake of colorectal cancer screening in Scotland (ARTICS): study protocol for a randomised controlled trial., BMC Public Health, 2013, 13, 849, doi: 10.1186/1471-2458-13-849.

  2. Results

    O'Carroll RE, Chambers JA, Brownlee L, Libby G, Steele RJ, Anticipated regret to increase uptake of colorectal cancer screening (ARTICS): A randomised controlled trial, Soc Sci Med, 2015 , 142, 118-127, doi: 10.1016/j.socscimed.2015.07.026.

Additional files

Editorial Notes