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

Quidde, Julia; Pan, Yiqi; Salm, M. L. van der; Hendi, Armin; Nilsson, Sven Erik G.; Stein, Alexander; Nestoriuc, Yvonne

doi:10.1186/s12885-018-4814-7

Cited by 17 publications

(29 citation statements)

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“…Several experimental studies indicate that informing patients about specific side effects of drugs can increase their occurrence (Silvestri et al, 2003; Mondaini et al, 2007; Jacobs et al, 2017). Conversely, the reduction of negative expectancies by psychological interventions is believed to prevent the occurrence of non-pharmacological side effects (Colagiuri et al, 2008; Quidde et al, 2018). The results of our study suggest that this may not necessarily apply to chemotherapy-induced nausea in the age of modern antiemetics.…”

Section: Discussionmentioning

confidence: 99%

“…In addition, despite the prospective design, our results cannot conclusively answer the question of causality between nausea expectancy and the occurrence of nausea after chemotherapy. Experimental designs that manipulate nausea expectancy before first-time chemotherapy will help to elucidate this issue (Quidde et al, 2018). Finally, asking patients about their expectancies to develop nausea might increase the occurrence of this side effect by eliciting a nocebo effect.…”

Section: Discussionmentioning

confidence: 99%

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Individual Factors Contributing to Nausea in First-Time Chemotherapy Patients: A Prospective Cohort Study

et al. 2019

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Objective The expectation of developing side effects can enhance the likelihood to develop them – a phenomenon referred to as nocebo effect. Whether nocebo effects can be reduced by lowering negative expectancies, is not clear. The aim of this prospective study was to learn more about the factors contributing to nausea expectancy and their potential role in actual occurrence of nausea in patients undergoing chemotherapy for the first time in their life. Methods Patients scheduled for moderately emetogenic chemotherapeutic regimens filled in questionnaires to assess state anxiety and quality of life and to rate the expectancy of nausea as a side effect of chemotherapy. Patient diaries were used to monitor the severity of post-chemotherapy nausea in the 4 days following chemotherapy administration. Bivariate analyses complemented by multiple regression analyses were performed to identify the relationship between nausea expectation and nausea occurrence. Results 121 female patients (mean age 53 years) with completed questionnaires were included in the analyses. The majority of the patients had a diagnosis of breast cancer (86%). The two main sources for nausea expectancy were positive history of nausea in other situations and state anxiety. Patients with high expectancy levels (first quartile) experienced greater nausea than those with lower expectancy levels. Bivariate analyses revealed a weak but non-significant association between nausea expectation and post-chemotherapy nausea. When controlling for age, type of cancer, history of nausea, state and trait anxiety, and global quality of life, positive history of nausea ( OR = 2.592; 95% CI, 1.0 to 6.67; p < 0.05), younger age ( OR = 0.95; 95% CI, 0.92 to 0.99; p < 0.05), and a lower quality of life ( OR = 0.97; 95% CI, 0.94 to 1.0; p < 0.05), but not nausea expectancy ( OR = 1.014; 95% CI, 0.51 to 2.02; p = 0.969), predicted the occurrence of post-chemotherapy nausea. Conclusion In this female cohort, younger patients with lower initial quality of life and a positive history of nausea were at higher risk to develop nausea after first time chemotherapy. These patients may benefit from psychological co-interventions that aim to enhance quality of life.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Individual Factors Contributing to Nausea in First-Time Chemotherapy Patients: A Prospective Cohort Study

et al. 2019

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“…A case example was provided to illustrate the nocebo effect (p. 52f) (48). Written by two investigators (YN and TK), its comprehensibility was evaluated by a self-help cancer patient group and adapted hereafter (39).…”

Section: Methodsmentioning

confidence: 99%

“…Crichton and Petrie (38) explained symptoms ostensibly caused by infrasound either by a nocebo effect or biological mechanisms and found differences in symptom reporting after an infrasound exposure. Evidence in the clinical context is missing up to now (39).…”

Section: Introductionmentioning

confidence: 99%

Minimizing Drug Adverse Events by Informing About the Nocebo Effect—An Experimental Study

et al. 2019

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Relevance: Informing patients about potential adverse events as part of the informed consent may facilitate the development of nocebo-driven drug adverse events (nocebo side effects). Objective: To investigate whether informing about the nocebo effect using a short information sheet can reduce nocebo side effects. Methods: A total of N = 44 participants with weekly headaches for at least 6 months were recruited using the cover story of a clinical trial for a headache medicine. In reality, all participants took a placebo pill and were randomized to the nocebo information group or the standard leaflet group. Participants were instructed to read the bogus medication leaflet entailing side effects information shortly before pill intake. The nocebo group additionally received an explanation about the nocebo effect as part of the leaflet. Questionnaires were completed at baseline, 2 min, and 4 days after the pill intake. We conducted general linear models with bootstrap sampling. Baseline symptoms were included as a covariate. Results: Most participants (70.5%) reported nocebo side effects at 2 min. Participants who received the nocebo information ( n = 24) reported less nocebo symptoms than the control group ( n = 20) (estimated difference: 3.3, BCa 95% CI [1.14; 5.15], p = 0.01, Cohen’s d = 0.59). Baseline symptoms, perceived sensitivity to medicine, and side effect expectations each moderated the group effect (estimated difference in slope: 0.47, BCa 95% CI [0.19; 0.73], p = 0.001, d = 0.75; 1.07 [0.27; 1.61], p = 0.006, d = 0.73; 1.57 [0.38; 2.76], p = 0.02, d = 0.58). No group differences were found at 4-day follow-up. After revealing the actual aim of the study, 86% of the participants evaluated the nocebo information to be helpful in general. Conclusions: Results provide the first evidence that informing about the nocebo effect can reduce nocebo side effects.

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“…The nocebo information group received a one-page text about the nocebo effect and its mechanisms; the control group received a text of the same length about the history of antidepressants. The nocebo information consisted of three main parts: a comprehensive explanation of the experienced nocebo effect, a distinction of pharmacological and non-pharmacological effects of a drug, and a description of expectations as one possible mechanism of the nocebo effect (31). Within the first paragraph, examples of expectations stemming from prior negative treatment experiences or from learning about the potential side effects from package inserts were given.…”

Section: Study Design and Proceduresmentioning

confidence: 99%

Informing About the Nocebo Effect Affects Patients’ Need for Information About Antidepressants—An Experimental Online Study

Nestoriuc

Pan

Kinitz³

et al. 2021

Front. Psychiatry

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Relevance: Understanding patients’ informational needs and adapting drug-related information are the prerequisites for a contextualized informed consent. Current information practices might rather harm by inducing nocebo effects.Objective: To investigate whether informing about the nocebo effect using a short information sheet affects patients’ need for information about antidepressants.Methods: A total of 97 patients taking recently prescribed antidepressants (≤4 months intake) were recruited over the internet and randomized to receiving either a one-page written information about the nocebo effect or a control text about the history of antidepressants. After experimental manipulation, informational needs about the side effects and mechanisms of antidepressants were assessed with 3 and 7 items on categorical and 5-point Likert scales. Group differences in informational needs were calculated with Chi-square tests and ANOVAs.Results: Patients received antidepressants for depression (84.5%) and/or anxiety disorders (42.3%). Three participants (6.0%) of the nocebo group reported previous knowledge of the nocebo effect. After the experimental manipulation, participants in the nocebo group reported a reduced desire for receiving full side effect information [X(4,97)2 = 12.714, Cramer’s V = 0.362, p = 0.013] and agreed more frequently to the usefulness of withholding information about possible side effects [X(4,97)2 = 14.878, Cramer’s V = 0.392, p = 0.005]. Furthermore, they desired more information about the mechanisms of antidepressants (F = 6.373, p = 0.013, partial η2 = 0.063) and, specifically, non-pharmacological mechanisms, such as the role of positive expectations (F = 16.857, p < 0.001, partial η2 = 0.151).Conclusions: Learning about the nocebo effect can alter patients’ informational needs toward desiring less information about the potential side effects of antidepressants and more information about general mechanisms, such as expectations. The beneficial effects of including nocebo information into contextualized informed consent should be studied clinically concerning more functional information-seeking behavior, which may ultimately lead to improved treatment outcomes, such as better adherence and reduced side effect burden.

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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

Cited by 17 publications

References 35 publications

Individual Factors Contributing to Nausea in First-Time Chemotherapy Patients: A Prospective Cohort Study

Individual Factors Contributing to Nausea in First-Time Chemotherapy Patients: A Prospective Cohort Study

Minimizing Drug Adverse Events by Informing About the Nocebo Effect—An Experimental Study

Informing About the Nocebo Effect Affects Patients’ Need for Information About Antidepressants—An Experimental Online Study

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