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Whilst this study did not reach its primary efficacy goal for response rate based on the prospectively defined RECIST criteria, the volumetric studies were certainly encouraging.
In this study, task self-efficacy and selected targeted aspects of self-regulatory efficacy (goal setting, planning and barriers) are assessed using measures based on those developed by Cramp and Brawley [ 21] for their GMCB exercise intervention study.
A follow-up Phase IIb bridging study enrolling 53 patients was discontinued in 2006 after an interim analysis because it was not expected that the study would meet its efficacy goal (discussed in [ 76]).
In this phase II study, everolimus monotherapy, administered at a dose of 10 mg day−1 in unselected patients, failed to achieve a predefined efficacy goal of 4-month PFS rate of 30% against heavily pretreated AGC, despite its mild toxicity.
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Such terminations are distinct from failure to reach the trial efficacy goals.
For example, psychological theories emphasize factors such as individual needs, values, personality, self efficacy, goals, incentives and job characteristics as important for work motivation [ 19, 20].
A phase II study in 21 patients with MBC previously treated with an anthracycline and/or a taxane reported a 5% PR rate and did not meet efficacy goals [ 45].
Theories of problem-solving have traditionally placed focus on individual characteristics such as self-efficacy, goal setting, and achievement.
These include boosting self-efficacy, goal setting, modelling, encouragement, feedback and self-monitoring.
These include personal determinants such as planning, attitude, self-efficacy, goal orientation / motivation, and participation in physical education or school sports [ 71].
The decision to include strategies to develop self-efficacy, goal setting and self-monitoring in the core components was based on the evidence from previous behaviour change research [ 50- 52].
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