Objective | Tools | Timing | Analysis |
---|---|---|---|
Assess the psychological impact of risk communication on women | - STAI (Q1) - Lerman’s cancer worry (Q2) - Qualitative interviews | Baseline, 3 months, 1 year, 4 years | - Comparisons between two experimental arms, controlling for baseline levels and other covariates where required |
Assess women’s comprehension of the information provided within MyPeBS, and their willingness to search for further information | - Comprehension questionnaire (Q3) - Information seeking behaviours questionnaire (Q4) - Qualitative interviews | Baseline, 3 months, 4 years | - Comparisons between arms and correlations between women’s information comprehension level, information-seeking behaviours and socio economic and demographic characteristics - Correlations with psychological characteristics (anxiety, cancer worry) |
Analyse MyPeBS participants' socio-economic and demographic characteristics as well as quality of life | - Quality of life (Q6) - Socio-demographic questionnaire (Q8) | Baseline, 4 years | - Comparisons between arms of women’s socio-economic characteristics and quality of life, focus on health inequalities. Use equality of proportion or Student test to compare the distribution of the variables across the two harms - Correlations with risk perceptions and screening uptake |
Assess perception of risk of breast cancer, and perceptions of efficacy and risks of prevention options | - Risk perception and behaviour change (Q5) - Information-seeking behaviour questionnaire (Q4) - Qualitative interviews | Baseline, 3 months, 4 years | - Comparisons between two experimental arms, controlling for baseline levels and other covariates where required - Examination of mediation effects on intentions and behaviour by risk appraisals and coping appraisals |
Measure overall satisfaction with the trial and acceptability of the risk-based approach | - Trial Program Satisfaction (Q7) - Qualitative interviews | 1 year, 4 years | - Comparison between arms and analysis of critical points within experimental arm |