Increasing uptake of FIT colorectal screening : protocol for the TEMPO randomised controlled trial testing a suggested deadline and a planning tool

Funding: This study is supported by an Early Diagnosis Advisory Group (EDAG) Project Grant from Cancer Research UK (C9227/A27877 - Increasing uptake of faecal immunochemical test (FIT) bowel screening: trial of providing a suggested deadline for FIT kit return, PI KAR, Co-investigators: CMC, AM, GJH, RJCS) and by a Response Mode Grant from the Scottish Chief Scientist Office (HIPS/17/23 - Increasing uptake of bowel cancer screening: development of a FIT planning support tool, PI: KAR, Co-investigators: SM, REOC, RCOC, AI, RJCS, MK).Introduction Screening can reduce deaths from colorectal cancer (CRC). Despite high levels of public enthusiasm, participation rates in population CRC screening programmes internationally remain persistently below target levels. Simple behavioural interventions such as completion goals and planning tools may support participation among those inclined to be screened but who fail to act on their intentions. This study aims to evaluate the impact of: (a) a suggested deadline for return of the test; (b) a planning tool and (c) the combination of a deadline and planning tool on return of faecal immunochemical tests (FITs) for CRC screening. Methods and analysis A randomised controlled trial of 40 000 adults invited to participate in the Scottish Bowel Screening Programme will assess the individual and combined impact of the interventions. Trial delivery will be integrated into the existing CRC screening process. The Scottish Bowel Screening Programme mails FITs to people aged 50–74 with brief instructions for completion and return. Participants will be randomised to one of eight groups: (1) no intervention; (2) suggested deadline (1 week); (3) suggested deadline (2 weeks); (4) suggested deadline (4 weeks); (5) planning tool; (6) planning tool plus suggested deadline (1 week); (7) planning tool plus suggested deadline (2 weeks); (8) planning tool plus suggested deadline (4 weeks). The primary outcome is return of the correctly completed FIT at 3 months. To understand the cognitive and behavioural mechanisms and to explore the acceptability of both interventions, we will survey (n=2000) and interview (n=40) a subgroup of trial participants. Ethics and dissemination The study has been approved by the National Health Service South Central—Hampshire B Research Ethics Committee (ref. 19/SC/0369). The findings will be disseminated through conference presentations and publication in peer-reviewed journals. Participants can request a summary of the results. Trial registration number clinicaltrials.govNCT05408169.Publisher PDFPeer reviewe

Anticipated regret to increase uptake of colorectal cancer screening (ARTICS):a randomised controlled trial

Objective. Screening is key to early detection of colorectal cancer. Our aim was to determine whether a simple anticipated regret (AR) intervention could increase colorectal cancer screening uptake. Methods. We conducted a randomised controlled trial of a simple, questionnaire-based AR intervention, delivered alongside existing pre-notification letters. 60,000 adults aged 50-74 from the Scottish National Screening programme were randomised to: 1) no questionnaire (control), 2) Health Locus of Control questionnaire (HLOC) or 3) HLOC plus anticipated regret questionnaire (AR). Primary outcome was guaiac Faecal Occult Blood Test (FOBT) return. Secondary outcomes included intention to return test kit and perceived disgust (ICK). Results. 59,366 people were analysed as allocated (Intentionto- treat (ITT)); there were no overall differences between treatment groups on FOBT uptake (control: 57.3%, HLOC: 56.9%, AR: 57.4%). 13,645 (34.2%) people returned questionnaires. Analysis of the secondary questionnaire measures showed that AR had an indirect effect on FOBT uptake via intention, whilst ICK had a direct effect on FOBT uptake over and above intention. The effect of AR on FOBT uptake was also moderated by intention strength: for less than strong intenders only, uptake was 4.2% higher in the AR (84.6%) versus the HLOC group (80.4%) (95% CI for difference (2.0, 6.5)). Conclusion. The findings show that psychological concepts including anticipated regret and perceived disgust (ICK) are important factors in determining FOBT uptake. However, there was no simple effect of the AR intervention in the ITT. We conclude that exposure to AR in those with low intentions may be required to increase FOBT uptake. Current controlled trials: www.controlledtrials. com number: ISRCTN74986452

Aspirin as an adjuvant treatment for cancer:feasibility results from the Add-Aspirin randomised trial

BACKGROUND: Preclinical, epidemiological, and randomised data indicate that aspirin might prevent tumour development and metastasis, leading to reduced cancer mortality, particularly for gastro-oesophageal and colorectal cancer. Randomised trials evaluating aspirin use after primary radical therapy are ongoing. We present the pre-planned feasibility analysis of the run-in phase of the Add-Aspirin trial to address concerns about toxicity, particularly bleeding after radical treatment for gastro-oesophageal cancer.METHODS: The Add-Aspirin protocol includes four phase 3 randomised controlled trials evaluating the effect of daily aspirin on recurrence and survival after radical cancer therapy in four tumour cohorts: gastro-oesophageal, colorectal, breast, and prostate cancer. An open-label run-in phase (aspirin 100 mg daily for 8 weeks) precedes double-blind randomisation (for participants aged under 75 years, aspirin 300 mg, aspirin 100 mg, or matched placebo in a 1:1:1 ratio; for patients aged 75 years or older, aspirin 100 mg or matched placebo in a 2:1 ratio). A preplanned analysis of feasibility, including recruitment rate, adherence, and toxicity was performed. The trial is registered with the International Standard Randomised Controlled Trials Number registry (ISRCTN74358648) and remains open to recruitment.FINDINGS: After 2 years of recruitment (October, 2015, to October, 2017), 3494 participants were registered (115 in the gastro-oesophageal cancer cohort, 950 in the colorectal cancer cohort, 1675 in the breast cancer cohort, and 754 in the prostate cancer cohort); 2719 (85%) of 3194 participants who had finished the run-in period proceeded to randomisation, with rates consistent across tumour cohorts. End of run-in data were available for 2253 patients; 2148 (95%) of the participants took six or seven tablets per week. 11 (0·5%) of the 2253 participants reported grade 3 toxicity during the run-in period, with no upper gastrointestinal bleeding (any grade) in the gastro-oesophageal cancer cohort. The most frequent grade 1-2 toxicity overall was dyspepsia (246 [11%] of 2253 participants).INTERPRETATION: Aspirin is well-tolerated after radical cancer therapy. Toxicity has been low and there is no evidence of a difference in adherence, acceptance of randomisation, or toxicity between the different cancer cohorts. Trial recruitment continues to determine whether aspirin could offer a potential low cost and well tolerated therapy to improve cancer outcomes.FUNDING: Cancer Research UK, The National Institute for Health Research Health Technology Assessment Programme, The MRC Clinical Trials Unit at UCL.</p