Table 1.
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