Anticipated Regret To Increase Colorectal cancer screening (ARTICS)

ISRCTN	ISRCTN74986452
DOI	https://doi.org/10.1186/ISRCTN74986452
Protocol serial number	N/A
Sponsor	University of Stirling (UK)
Funder	Chief Scientist Office of the Scottish Executive Health Department (UK) ref: CZH/4/793

Submission date: 11/10/2012
Registration date: 08/11/2012
Last edited: 14/02/2023

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

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-looking-at-attitudes-to-health-and-bowel-screening-in-scotland-artics

Contact information

Prof Ronan O'Carroll
Scientific

University of Stirling
Division of Psychology
School of Natural Sciences
Stirling
FK9 4LA
United Kingdom

Email	reo1@stir.ac.uk

Study information

Primary study design	Interventional
Study design	Three-armed prospective randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	ARTICS
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	31/05/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	60000
Total final enrolment	60000
Key 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
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/10/2012
Date of final enrolment	31/05/2014

Locations

Countries of recruitment

United Kingdom
Scotland

Study participating centre

University of Stirling

Stirling
FK9 4LA
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2015		Yes	No
Protocol article	protocol	16/09/2013		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Plain English results			14/02/2023	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

14/02/2023: plain English results link and total final enrolment added.