Optimizing expectations to prevent side effects and enhance quality of life in breast cancer patients undergoing endocrine therapy: study protocol of a randomized controlled trial

Table 2 Study measures

		Baseline pre-intervention	Post-intervention	Follow-up (3 and 6 months after AET intake)
Inclusion criteria	Interview measures
	Structured psychiatric interview (mini-dips)	x¹
	Demographic and medical data	x
	Questionnaire measures
Primary + Secondary Outcomes	Physical symptoms and side effects + coping (GASE+Coping)	x		x
	Quality of life (EORTC QLQ C30 & BR23)	x		x
	Adherence (MARS-D), Adherence Intention	x	x	x
Expectation Scales	Expected side effects + expected coping (GASE-Expect + * *Coping)	x	x	x
	Illness beliefs (IPQ-B)	x	x	x
	Beliefs about medicines (BMQ-D)	x	x	x
Process Variables	Fear of progression (PA-F-K)	x	x	x
	Anxiety and depression (HADS)	x	x	x
	Knowledge hormone receptor	x	x	x
	Treatment evaluation		x²
Control Variables	Somatosensory amplification (SSAS)	x
	Prior experiences with endocrine treatment	x
	Partnership quality	x
	Additional medication	x		x

Notes:
¹The psychiatric interview is conducted prior to the measurement to check the inclusion criteria.
²Completed after every therapy session in the intervention groups only.

ISSN: 1471-2407