Anticipated Regret To Increase Colorectal cancer screening (ARTICS)
| ISRCTN | ISRCTN74986452 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74986452 |
| Secondary identifying numbers | N/A |
- 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
Contact information
Prof Ronan O'Carroll
Scientific
Scientific
University of Stirling
Division of Psychology
School of Natural Sciences
Stirling
FK9 4LA
United Kingdom
| reo1@stir.ac.uk |
Study information
| Study design | Three-armed prospective randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/10/2012 |
| Completion date | 31/05/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 60,000 individuals, randomised to 3 arms (20,000 in each arm) |
| 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
- Scotland
- United Kingdom
Study participating centre
University of Stirling
Stirling
FK9 4LA
United Kingdom
FK9 4LA
United Kingdom
Sponsor information
University of Stirling (UK)
University/education
University/education
c/o Carol Johnstone
Research and Enterprise Office
Stirling
FK9 4LA
Scotland
United Kingdom
| carol.johnstone@stir.ac.uk | |
| Website | http://www.stir.ac.uk/ |
"ROR" |
https://ror.org/045wgfr59 |
Funders
Funder type
Government
Chief Scientist Office of the Scottish Executive Health Department (UK) ref: CZH/4/793
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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? |
|---|---|---|---|---|---|
| Protocol article | protocol | 16/09/2013 | Yes | No | |
| Results article | results | 01/10/2015 | Yes | No | |
| Plain English results | 14/02/2023 | No | Yes |
Editorial Notes
14/02/2023: plain English results link and total final enrolment added.
