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Table 1 Schedule for enrolment, interventions and assessments

From: Preventing adverse events of chemotherapy by educating patients about the nocebo effect (RENNO study) – study protocol of a randomized controlled trial with gastrointestinal cancer patients

Time points Study period
Allocation Post-allocation
t1pre t1 t1post t2 t3
 Eligibility screena     
 Informed consent     
 Randomized assignment     
 Nocebo-education group      
 Attention control group      
 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    
  1. 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
  2. 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
  3. bAssessed symptoms include fatigue, nausea, diarrhea, vomiting, headache, shortness of breath, and rash
  4. cSeverity of toxicity is assessed by the clinician at every cycle
  5. dKnowledge about the nocebo effect is only assesses in the nocebo education group