Optimizing Expectations About Endocrine Treatment for Breast Cancer: Results of the Randomized Controlled PSY-BREAST Trial.

Background: Medication side effects are strongly determined by non-pharmacological, nocebo mechanisms, particularly patients' expectations. Optimizing expectations could minimize side effect burden. This study evaluated whether brief psychological expectation management training (EXPECT) optimizes medication-related expectations in women starting adjuvant endocrine therapy (AET) for breast cancer. Method: In a multisite randomized controlled design, 197 women were randomized to EXPECT, supportive therapy (SUPPORT), or treatment as usual (TAU). The three-session cognitive-behavioral EXPECT employs psychoeducation, guided imagery, and side effect management training. Outcomes were necessity-concern beliefs about AET, expected side effects, expected coping ability, treatment control expectations, and adherence intention. Results: Both interventions were well accepted and feasible. Patients' necessity-concern beliefs were optimized in EXPECT compared to both TAU and SUPPORT, d = .41, p < .001; d = .40, p < .001. Expected coping ability and treatment control expectations were optimized compared to TAU, d = .35, p = .02; d = .42, p < 001, but not to SUPPORT. Adherence intention was optimized compared to SUPPORT, d = .29, p = .02, but not to TAU. Expected side effects did not change significantly. Conclusion: Expectation management effectively and partly specifically (compared to SUPPORT) modified medication-related expectations in women starting AET. Given the influence of expectations on long-term treatment outcome, psychological interventions like EXPECT might provide potential pathways to reduce side effect burden and improve quality of life during medication intake.

Facilitating adherence to endocrine therapy in breast cancer: stability and predictive power of treatment expectations in a 2-year prospective study.

PURPOSE: To identify modifiable factors predictive of long-term adherence to adjuvant endocrine therapy (AET). METHODS: As part of a 2-year cohort study in primary care (n = 116), we investigated whether initial treatment expectations predict adherence at 24 months after controlling for demographic, medical, and psychosocial variables. Treatment expectations were measured as necessity-concern beliefs, expected side-effect severity, and expected coping with side effects. Their stability over time and differences of trajectories between the adherent and nonadherent group were examined. RESULTS: Nonadherence at 24 months was 14.7% (n = 17). Side-effect severity at 3 months [OR 0.25, 95% CI (0.08, 0.81), p = 0.02] and necessity-concern beliefs [OR 2.03, 95% CI (1.11, 3.72), p = 0.02] were the sole predictors of adherence. Necessity-concern beliefs remained stable over 2 years, whereas expected side-effect severity (p = 0.01, η p2  = 0.07) and expected coping with side effects became less optimistic over time (p < 0.001, η p2  = 0.19), the latter particularly among nonadherers (p < 0.01, η p2  = 0.10). CONCLUSIONS: Patients' initial necessity-concern beliefs about the AET and early severity of side effects affect long-term adherence. Expecting poor management of side effects may also facilitate nonadherence. We suggest that discussing benefits, addressing concerns of AET, and providing side-effect coping strategies could constitute a feasible and promising option to improve adherence in clinical practice.

What do women with breast cancer expect from their treatment? Correlates of negative treatment expectations about endocrine therapy.

OBJECTIVES: Patients' negative treatment expectations can lead to nocebo-related side effects and non-initiation of treatment. This study aims to identify correlates of treatment expectations in patients with breast cancer before the start of endocrine therapy. METHODS: Expectations were assessed in a cross-sectional sample of 166 patients with breast cancer after receiving treatment information. Side effect expectations (one item) and treatment necessity-concern balance (Beliefs about Medicines Questionnaire) were assessed. Correlates were analyzed using regression analyses. The structure of treatment expectations was investigated using a network analysis. RESULTS: About 25% of patients expressed negative expectations. Higher side effect expectations were associated with lower treatment efficacy expectations (ß = -0.20, p = 0.01), higher medication overuse beliefs (ß = 0.17, p = 0.01), and a negative treatment appraisal before study treatment information (ß = -0.17, p = 0.02). A negative necessity-concern balance was associated with lower treatment efficacy expectations (ß = 0.36, p < 0.001), lower adherence intention (ß = 0.21, p < 0.001), and no knowledge of tumor's receptor status (ß = 0.21, p < 0.001); furthermore, it was associated with higher medication harmfulness beliefs (ß = -0.16, p = 0.02), negative treatment pre-appraisal (ß = 0.15, p = 0.01), higher somatosensory amplification (ß = -0.14, p = 0.02), and higher education (ß = -0.12, p = 0.02). The most important network node was the concern that endocrine therapy disrupts life. CONCLUSION: Negative treatment expectations before treatment start are mainly associated with psychological variables. These results are relevant for patient education in clinical settings. To improve expectations, clinicians might emphasize treatment efficacy and discuss general and specific medication concerns. Improving treatment knowledge could also be beneficial. Copyright © 2016 John Wiley & Sons, Ltd.

Framing and personalizing informed consent to prevent negative expectations: An experimental pilot study.

OBJECTIVE: Informing patients about medical treatments and their possible side effects is ethically and legally obligatory but may trigger negative expectations and nocebo-related side effects. This pilot study aims to investigate the effect of different informed consent procedures on treatment expectations for adjuvant breast cancer treatments (Study 1: endocrine therapy; Study 2: chemotherapy). METHOD: Using an experimental 2-factorial design, healthy women were informed about endocrine therapy (n = 60) or chemotherapy (n = 64) within a hypothetical scenario. Information was framed with or without treatment benefit information and delivered in a personalized or standardized interaction. Primary outcomes were necessity-concern beliefs about the treatment and side-effect expectations, secondary outcomes were decisional conflicts. RESULTS: In Study 1, side-effect expectations (η²p= .08) and decisional conflicts (η²p = .07) were lower when framed treatment information was given. Providing personalized information resulted in more functional necessity-concern beliefs (η²p = .06) and lower decisional conflicts (η²p = .07). Personalizing and framing of information resulted in more functional necessity-concern beliefs (η²p = .10) and lower decisional conflicts. In Study 2, necessity-concern beliefs were more functional with framing (η²p = .06). Participants in the personalized groups reported lower decisional conflicts (η²p = .06). No differences in side-effect expectations were revealed. CONCLUSIONS: This is the first study to provide evidence for optimized treatment expectations through altered informed consent strategies. The results emphasize that framing and personalizing informed consent can positively influence treatment expectations and reduce decisional conflicts. However, generalizations are impaired by the study's pilot character. The potential to prevent nocebo responses in clinical practice should be analyzed. (PsycINFO Database Record

Informing women with breast cancer about endocrine therapy: effects on knowledge and adherence.

OBJECTIVE: Adherence to adjuvant endocrine therapy in women with breast cancer is low, and patients are not informed sufficiently. This study analyzes the effects of a structured treatment information on patients' satisfaction, knowledge, and adherence. METHODS: An interventional single cohort study of postoperative women with estrogen-receptor-positive breast cancer was conducted to study the effects of enhanced information about endocrine therapy given additionally to clinical routine information. Knowledge and satisfaction with additional information given 1-3 weeks after surgery were assessed before and after informing patients; adherence and knowledge were measured 3 months after start of treatment. RESULTS: A total of 137 patients were analyzed before and after provision of enhanced treatment information as well as 3 months after start of endocrine therapy. Enhanced information increased satisfaction with information and knowledge. The percentage of patients who knew their estrogen receptor status increased from 50% to 93%. At 3 months follow-up, 60% still had correct knowledge. Patients who learned their receptor status were older, and those who forgot had lower cognitive abilities and lower educational level. Patients with higher satisfaction, better learning, and comprehension directly after enhanced information showed better adherence at 3 months follow-up. CONCLUSION: Patients, especially older ones, can benefit from enhanced treatment information given additionally to routine care. Enhanced information about mode of action and potential side effects of endocrine therapy when included into clinical routine might foster patient autonomy and prevent early disruptions in adherence.