Trial reportBMC cancer2018
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.
Trial report in BMC cancer, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05019612 (The Role of Expectations on Complaints and Well-being After Endometriosis Surgery), which is not on this map. Cited by 12 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
The Role of Expectations on Complaints and Well-being After Endometriosis Surgery
Who cites it
12 citing papers in PubMed.
- Preventing adverse events of chemotherapy for gastrointestinal cancer by educating patients about the nocebo effect: a randomized-controlled trial.BMC cancer · 2022Trial
- Effect of Briefing on Acupuncture Treatment Outcome Expectations, Pain, and Adverse Side Effects Among Patients With Chronic Low Back Pain: A Randomized Clinical Trial.JAMA network open · 2021Trial
- The effect of clinician-expressed empathy and nocebo-alleviating information on breast-cancer-patients' anxiety and side effects during active chemotherapy: A clinical feasibility study.PEC innovation · 2025Article
- Identifying the psychological effects of nocebo education: results from two pre-registered experiments.Journal of behavioral medicine · 2024Article
- Article
- How Do Adolescent and Young Adult Patients with Cancer Manage Their Chemotherapy-Related Symptoms at Home?Journal of adolescent and young adult oncology · 2023Article
- Article
- Possible alleviation of symptoms and side effects through clinicians' nocebo information and empathy in an experimental video vignette study.Scientific reports · 2022Article
- Recent Advances in Anti-Metastatic Approaches of Herbal Medicines in 5 Major Cancers: From Traditional Medicine to Modern Drug Discovery.Antioxidants (Basel, Switzerland) · 2021Review
- Informing About the Nocebo Effect Affects Patients' Need for Information About Antidepressants-An Experimental Online Study.Frontiers in psychiatry · 2021Article
- Individual Factors Contributing to Nausea in First-Time Chemotherapy Patients: A Prospective Cohort Study.Frontiers in pharmacology · 2019Article
- Minimizing Drug Adverse Events by Informing About the Nocebo Effect-An Experimental Study.Frontiers in psychiatry · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
Abstract
backgroundPatients undergoing chemotherapy are highly burdened by side effects. These may be caused by the pharmacodynamics of the drug or be driven by psychological factors such as negative expectations or pre-conditioning, which reflect nocebo effects. As such, negative pre-treatment expectations or prior experiences might exacerbate the burden of chemotherapy side effects. Educating patients about this nocebo effect has been put forward as a potential strategy to optimize patients' pre-treatment expectations. In this study, we evaluate whether a briefing about the nocebo effect is efficacious in reducing side effects.
methodsIn this exploratory study, a total number of n = 100 outpatients with newly diagnosed gastrointestinal cancers are randomized 1:1 to an information session about the nocebo effect (nocebo-education) or an attention control group (ACG) with matching interaction time. Assessments take place before the intervention (T1 pre), post-intervention (T1 post), and 10 days (T2) and 12 weeks (T3) after the initial chemotherapy. The primary outcomes are the patient-rated number and intensity of side effects at 10-days and at 12-weeks follow-up. Secondary outcomes include coping with side effects, tendency to misattribute symptoms, compliance intention, attitude towards the chemotherapy, co-medication to treat side effects and the clinician-rated severity of toxicity. Further analyses are conducted to investigate whether a potential beneficial effect is mediated by a change of expectations before and after the intervention. DISCUSSION: Informing patients about the nocebo effect might be an innovative and feasible intervention to reduce the burden of side effects and strengthen patients' perceived control over adverse symptoms.
trial registrationThe trial is registered at the German Clinical Trials Register (ID: DRKS00009501 ; retrospectively registered on March 27, 2018). The first patient was enrolled on September 29, 2015.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.