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

Meike C Shedden-Mora, Yiqi Pan, Sarah R Heisig, Pia von Blanckenburg, Winfried Rief, Isabell Witzel, Ute-Susann Albert, Yvonne Nestoriuc, Meike C Shedden-Mora, Yiqi Pan, Sarah R Heisig, Pia von Blanckenburg, Winfried Rief, Isabell Witzel, Ute-Susann Albert, Yvonne Nestoriuc

Abstract

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.

Keywords: adjuvant endocrine treatment; breast cancer; expectation management; nocebo effect; oncology; psychological intervention; side effect.

Conflict of interest statement

Winfried Rief is Editor-in-Chief of Clinical Psychology in Europe but played no editorial role for this particular article. Apart from that, the authors have declared that no competing interests exist.

Figures

Figure 1. Patient Flow (CONSORT)
Figure 1. Patient Flow (CONSORT)
Note. AET = adjuvant endocrine treatment; TAU = treatment as usual; SUPPORT = supportive therapy; EXPECT = expectation management training. aOf n = 203 randomized patients, 6 were identified as non-eligible post-randomization and therefore excluded.
Figure 2. Expectations at Baseline and Post-Intervention
Figure 2. Expectations at Baseline and Post-Intervention
Note. Values shown are estimated marginal means (error bars: ± 1 standard error) from linear mixed models. TAU = treatment as usual, SUPPORT = supportive therapy, EXPECT = expectation management training. Numbers after scale names indicate the range. *p < .05. **p < .01
Figure 3. Patients’ Evaluation of EXPECT and…
Figure 3. Patients’ Evaluation of EXPECT and SUPPORT Interventions
Note. General = general satisfaction with the intervention; EXPECT-specific = specific components of expectation management training; SUPPORT-specific = therapeutic components imminent to supportive therapy. Statistics are between-group comparisons (ANOVAs). *p < .05. **p < .01.

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