Trial reportBMC cancer2013
Optimizing expectations to prevent side effects and enhance quality of life in breast cancer patients undergoing endocrine therapy: study protocol of a randomized controlled trial.
Trial report in BMC cancer, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 33 papers, 4 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Clinical Application of Nocebo Research: Optimizing Expectations of Breast Cancer Patients to Prevent Nocebo Side Effects and Decrease of Quality of Life During Adjuvant Endocrine Therapy (DFG, NE 1635/2-1)
The Role of Expectations on Complaints and Well-being After Endometriosis Surgery
Who cites it
33 citing papers in PubMed, 4 syntheses or guidelines pooled it, 67 citations in OpenAlex.
- Role of expectations in clinical outcomes after deep brain stimulation in patients with Parkinson's disease: a systematic review.Journal of neurology · 2023Pooled it
- Are Patients WithFrontiers in pharmacology · 2019Pooled it
- Patients' Expectations Predict Surgery Outcomes: A Meta-Analysis.International journal of behavioral medicine · 2016Pooled it
- Interventions for preparing patients for chemotherapy and radiotherapy: a systematic review.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2014Pooled it
- Optimization of an Information Leaflet to Influence Medication Beliefs in Women With Breast Cancer: A Randomized Factorial Experiment.Annals of behavioral medicine : a publication of the Society of Behavioral Medicine · 2023Trial
- Preventing adverse events of chemotherapy for gastrointestinal cancer by educating patients about the nocebo effect: a randomized-controlled trial.BMC cancer · 2022Trial
- Trial
- Participant-Reported Symptoms and Their Effect on Long-Term Adherence in the International Breast Cancer Intervention Study I (IBIS I).Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2017Trial
- Learning to experience side effects after antidepressant intake - Results from a randomized, controlled, double-blind study.Psychopharmacology · 2017Trial
- 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
- Treatment expectations of patients and clinicians: a cross-sectional study.Frontiers in psychiatry · 2024Article
- A hermeneutic phenomenological study on the disease experience among young women with breast cancer.Asia-Pacific journal of oncology nursing · 2023Article
- Bibliometric analysis and visualization of endocrine therapy for breast cancer research in the last two decade.Frontiers in endocrinology · 2023Article
- Development and psychometric validation of the hospitalized patients' expectations for treatment scaleFrontiers in psychiatry · 2023Article
- Possible alleviation of symptoms and side effects through clinicians' nocebo information and empathy in an experimental video vignette study.Scientific reports · 2022Article
- Supporting adjuvant endocrine therapy adherence in women with breast cancer: the development of a complex behavioural intervention using Intervention Mapping guided by the Multiphase Optimisation Strategy.BMC health services research · 2022Article
- Article
- Patient-Reported Outcomes From Phase III Neoadjuvant Systemic Trial Comparing Neoadjuvant Chemotherapy With Neoadjuvant Endocrine Therapy in Pre-Menopausal Patients With Estrogen Receptor-Positive and HER2-Negative, Lymph Node-Positive Breast Cancer.Frontiers in oncology · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAdjuvant endocrine therapy can improve disease-free survival and time before recurrence in breast cancer patients. However, it is associated with considerable side effects that negatively affect patients' quality of life and cause non-adherence. The recently demonstrated effect of individual expectations on side-effect development (nocebo effect) suggests that psychological factors play a role in the prevention of side effects. The aim of this study is to evaluate cognitive-behavioral side-effect prevention training (SEPT) for breast cancer patients. This article describes the study protocol and applied research methods. METHODS/
designIn a randomized controlled trial, 184 female breast cancer patients are assigned to receive either SEPT, standard medical care or a manualized supportive therapy at the start of adjuvant endocrine treatment. SEPT consists of three sessions of cognitive-behavioral training including psychoeducation to provide a realistic view of endocrine therapy, imagination-training to integrate positive aspects of medication into daily life, and side-effect management to enhance expectations about coping ability. Side effects three months after the start of endocrine therapy serve as primary outcomes. Secondary outcomes include quality of life, coping ability and patients' medication adherence. Patients' expectations (i.e., expectations about side effects, coping ability, treatment and illness) are analyzed as mediators. DISCUSSION: The optimization of expectations might be a potential pathway in health care to improve patients' quality of life during long-term medication intake. The results will provide implications for a possible integration of evidence-based prevention training into clinical practice.
trial registrationClinicalTrials.gov, (NCT01741883).
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Identifiers
What OpenQuestion holds
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.