Is it best to expect the worst? Influence of patients' side-effect expectations on endocrine treatment outcome in a 2-year prospective clinical cohort study

Nestoriuc, Yvonne; Blanckenburg, Pia von; Schuricht, Franziska; Barsky, Arthur J.; Hadji, Peyman; Albert, U.-S.; Rief, Winfried

doi:10.1093/annonc/mdw266

Cited by 84 publications

(82 citation statements)

References 29 publications

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“…These discussions may encourage more realistic expectations of the likelihood of experiencing adverse effects, which have been shown to be powerful drivers of subsequent experience 37 and adherence in the adjuvant setting. 38 …”

Section: Discussionmentioning

confidence: 99%

Participant-Reported Symptoms and Their Effect on Long-Term Adherence in the International Breast Cancer Intervention Study I (IBIS I)

Smith

Šestak

Howell

et al. 2017

JCO

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PurposeTo assess the role of participant-reported symptoms on long-term adherence to preventive therapy in the United Kingdom sample of the International Breast Cancer Intervention Study (IBIS-I). IBIS-I was a randomized controlled trial that investigated the effectiveness of tamoxifen in reducing the risk of breast cancer among women at increased risk of the disease.Participants and MethodsWomen were randomly assigned to tamoxifen versus placebo (20 mg/day; n = 4,279). After 456 exclusions, 3,823 women were included in this analysis. Adherence (< 4.5 years or ≥ 4.5 years) was calculated using data from six monthly clinical visits. Analyses were adjusted for age, Tyrer-Cuzick risk, smoking, use of hormone replacement therapy, menopausal status, baseline menopausal symptoms, and treatment.ResultsOverall, 69.7% of women were adherent for at least 4.5 years (tamoxifen: 65.2% v placebo: 74.0%; P < .001). Differences in adherence between treatment arms were observed from 12 months onward (all P < .01) and were largest at 54 months. Dropout rates were highest in the first 12 to 18 months and decreased thereafter. Women reporting nausea/vomiting were less likely to be adherent in both the tamoxifen (odds ratio [OR], 0.57; 95% CI, 0.37 to 0.86; P = .007) and placebo (OR, 0.58; 95% CI, 0.37 to 0.93; P = .023) arms. Headaches were associated with adherence only in the placebo arm (OR, 0.62; 95% CI, 0.42 to 0.91; P = .016), whereas gynecologic symptoms were significant only in the tamoxifen arm (OR, 0.77; 95% CI, 0.62 to 0.97; P = .024). Effect sizes for each symptom on adherence were not significantly different between the treatment groups (P > .05). In both treatment arms, we observed significant trends for lower adherence with increasing severity for all symptoms (P < .01) except headaches (P = .054).ConclusionIn the IBIS-I trial, experiencing predefined symptoms in the first 6 months reduced long-term adherence. Effects were similar between treatment arms, suggesting that women were attributing age-related symptoms to preventive therapy. Interventions were required to support symptom management.

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Section: Discussionmentioning

confidence: 99%

Participant-Reported Symptoms and Their Effect on Long-Term Adherence in the International Breast Cancer Intervention Study I (IBIS I)

Smith

Šestak

Howell

et al. 2017

JCO

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“…This can take the form of a general belief that an individual is highly sensitive to the effects of medication in general or sensitive to specific type of medication (Horne et al, 2013; Faasse et al, 2015b). For example, expectations about developing medication side effects for endocrine therapy following breast cancer predicts more problems after treatment onset (Nestoriuc et al, 2016). …”

Section: Examples Of Empirical Results To Components Of the Expectatimentioning

confidence: 99%

Can Psychological Expectation Models Be Adapted for Placebo Research?

Rief

Petrie

2016

Front. Psychol.

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Placebo responses contribute substantially to the effect and clinical outcome of medical treatments. Patients' expectations have been identified as one of the major mechanisms contributing to placebo effects. However, to date a general theoretical framework to better understand how patient expectations interact with features of medical treatment has not been developed. In this paper we outline an expectation model that can be used as framework for experimental studies on both placebo and nocebo mechanisms. This model is based on psychological concepts of expectation development, expectation maintenance, and expectation change within the typical paradigms used in placebo research. This theoretical framework reflects the dynamic aspects of the interaction between expectations and medical treatment, and offers a platform to combine psychological and neurophysiological research activities. Moreover, this model can be used to identify important future research questions. For example, we argue that the dynamic processes of expectation maintenance vs. expectation changes are not sufficiently addressed in current research on placebo mechanisms. Therefore, the question about how to change and optimize patients' expectations prior to treatment should be a special focus of future clinical research.

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“…In keeping with these results, a number of longitudinal studies have examined how prospective patient expectations are related to later experience of side effects and QOL in cancer survivors. Often referred to as response expectancies, these have been shown to have associations with actual experience of side effects in that, when certain side effects are expected, they are more likely to be later reported . This has been termed the “nocebo” effect and is considered a neurobiological problem influenced by the way in which information is presented to patients .…”

Section: Discussionmentioning

confidence: 99%

Expecting the worst? The relationship between retrospective and prospective appraisals of illness on quality of life in prostate cancer survivors

et al. 2018

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Is it best to expect the worst? Influence of patients' side-effect expectations on endocrine treatment outcome in a 2-year prospective clinical cohort study

Abstract: ClinicalTrials.gov Identifier: NCT02088710.

Cited by 84 publications

References 29 publications

Participant-Reported Symptoms and Their Effect on Long-Term Adherence in the International Breast Cancer Intervention Study I (IBIS I)

Participant-Reported Symptoms and Their Effect on Long-Term Adherence in the International Breast Cancer Intervention Study I (IBIS I)

Can Psychological Expectation Models Be Adapted for Placebo Research?

Expecting the worst? The relationship between retrospective and prospective appraisals of illness on quality of life in prostate cancer survivors

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