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. 2018 Sep 24;18:916. doi: 10.1186/s12885-018-4814-7

Table 1.

Schedule for enrolment, interventions and assessments

Time points Study period
Allocation Post-allocation
t1pre t1 t1post t2 t3
ENROLMENT
 Eligibility screena
 Informed consent
 Randomized assignment
INTERVENTIONS
 Nocebo-education group
 Attention control group
ASSESSMENTS
 Baseline variables
  Demographic and medical characteristics
  Distress Thermometer
  Information coping style
 Outcome variables
  Side effect number and intensity (GASE)b
  Coping with side effects (GASE-Coping)
  Misattribution of symptoms (GASE-Attribution)
  Co-medication to treat side effects (yes/no)
  Compliance intention
  Attitude towards the chemotherapy
  Severity of toxicity (CTC)c
 Further variables
  Expected side effects (GASE-Expect)
  Expected coping with side effects (GASE-Coping Expect)
  Expected efficacy of chemotherapy
  Relevance of the conversation
  Knowledge about the nocebo effectd
  Disease progression

Note. The time points T1-pre and T1-post refer to the intervention whereas the T2 and T3 refer to the chemotherapy (10 days and 12 weeks after the initial chemotherapy). GASE Generic Assessment of Side Effects, CTC Common Toxicity Criteria

aThe eligibility screening takes place in two steps. In the first step, medical eligibility criteria are checked, whereas in the second step, all further criteria are assessed as part of the health professional-patient communication right before the signing of the informed consent

bAssessed symptoms include fatigue, nausea, diarrhea, vomiting, headache, shortness of breath, and rash

cSeverity of toxicity is assessed by the clinician at every cycle

dKnowledge about the nocebo effect is only assesses in the nocebo education group