The GSE-questionnaire operationalizes the psychological construct „self efficacy", consisting of 10 items ranging from 1 = Not at all true, 2 = Hardly true, 3 = Moderately true to 4 = Exactly true.
Susceptibility of breast cancer consisted of three items scored from 3 to 15, seriousness of breast cancer consisted of six items scored from 6 to 30, BSE benefits consisted of four items scored from 4 to 20, BSE barriers consisted of eight items scored from 8 to 40 and BSE self-efficacy consisted of 10 items scored from 10 to 50.
Determinants, such as awareness, attitudes, perceived norms and self-efficacy, consist of specific beliefs: thoughts, associations, perceptions, et cetera.
Self-efficacy consists of cognitive, emotional and behavioural components that are interrelated and affect each other.
The formal efficacy analysis consisted of a set of analyses of covariance (ANCOVAs), one for each efficacy endpoint.
The primary efficacy dataset consisted of all randomly assigned patients who took ≥1 dose of double-blind study medication.
The efficacy population consisted of 2536 patients, after exclusion of 136 (5.1%) patients from the safety population, most commonly because of age < 35 years (n = 119).
The efficacy set consisted of 23 male and 16 female patients, median age 58.6, 95% ECOG score ≤1, 74% with colon cancer, and 26% with rectal cancer.
In the pivotal trial, the primary efficacy population consisted of 59 patients with chronic lymphocytic leukemia (CLL) refractory to fludarabine and alemtuzumab.
