Improving cancer symptom awareness and help-seeking among adults living in socioeconomically deprived communities in the UK using a facilitated health check: A protocol for the Awareness and Beliefs About Cancer (ABACus) Randomised Control Trial

Abstract

BackgroundCancer survival is lower in socioeconomically deprived communities, partly due to low awareness of symptoms, negative beliefs and delayed help-seeking. We developed an interactive health check questionnaire facilitated by trained lay advisors. It entails 29 questions about background, lifestyle and health with tailored behaviour change advice. Personalised results are printed using a traffic light (red/amber/green) system, highlighting areas where action should be taken. This is an individually randomised control trial to test effectiveness of the health check on symptom recognition.MethodsA total 246 participants aged 40+ years will be recruited from community and healthcare settings in socioeconomically deprived areas of Yorkshire and South Wales. Participants will be randomised to receive the health check or standard care (1:1 ratio). Outcome measures include: adapted Awareness and Beliefs about Cancer (primary outcome), brief State Trait Anxiety Inventory, intentions and motivation to adopt recommended health behaviours (early symptom presentation, cancer screening and lifestyle behaviours), adapted Client Service Receipt Inventory, brief medical history/screening and demographic questionnaire at: baseline; 2-weeks; and 6-months post-randomisation. A purposive sample of intervention sessions will be audio-recorded (n = 24) and half will additionally be observed (n = 12). Semi-structured interviews will take place at 2-weeks (n = 30) and 6-months (n = 15–20) post-randomisation. The primary analysis will compare cancer symptom recognition scores between arms at 2-weeks. Secondary analysis will assess cancer beliefs, barriers/time to presentation, screening and lifestyle behaviours, anxiety and costs. A process evaluation will assess intervention fidelity, dose and contamination.The London-Surrey NHS Research Ethics Committee (Ref: 17/LO/1507) approved this trial.DiscussionThis is a trial of a theoretically underpinned complex intervention which has undergone phase 1 and 2 development work. The findings will evaluate evidence about the effect of the health check on symptom awareness. Although there are few exclusion criteria there are limitations regarding the population we are able to reach, who may have even higher risks of late diagnosis and poor cancer prognosis. However, the health check has the potential to improve cancer symptom awareness and encourage early help-seeking behaviour in deprived populations, thereby reducing inequalities in longer term cancer outcomes.Trial RegistrationRetrospectively registered with ISRCTN (Ref:ISRCTN16872545) on 12.01.2018.

Recruitment And Retention Of Participants From Socioeconomically Deprived Communities: Lessons From The Awareness And Beliefs About Cancer (ABACus3) Randomised Controlled Trial

“…We used thematic analysis (22) and 100% of lay advisor interviews were double coded by HQS and SG with the aid of the NVivo 11 data management software (23). The qualitative data will be reported in detail separately, as per the trial protocol (16).…”

“…Interviews were conducted by fellow ABACu3 researchers (HQS, YM and SG) with the aid of interview topic guides revised throughout the trial. The qualitative results from this trial, including the interviews with the lay advisors, the interviews with study participants and the intervention delivery audio recordings, are presented in a separate process evaluation paper (16).…”

“…Common reasons given by members of the public for declining to participate included not being interested in the study (n = 42) or not having enough time (n = 62). Detailed results will be reported separately, as per trial protocol (16).…”

Recruitment And Retention Of Participants From Socioeconomically Deprived Communities: Lessons From The Awareness And Beliefs About Cancer (ABACus3) Randomised Controlled Trial.

“…All patient-facing study materials (participant information sheets, consent forms, questionnaires) were written with consideration to the national average literacy levels and reviewed by the trial's Patient and Public Involvement group prior to recruitment, to ensure suitability for the target population (16) . Table 1 summarises the strategies employed to recruit and retain our participant sample in preparation for recruitment and after the participants were recruited.…”

“…There were high retention rates of recruited participants at both 2-weeks (90.5%) and 6-months (85.0%) follow-up points, which meant that the study was adequately powered. Detailed results will be reported separately, as per trial protocol (16). Table 2 illustrates the participant-reported demographic characteristics of the baseline sample.…”