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Table 1 Summary of objectives, statistical analyses and tools

From: Study protocol comparing the ethical, psychological and socio-economic impact of personalised breast cancer screening to that of standard screening in the “My Personal Breast Screening” (MyPeBS) randomised clinical trial

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