Discussion
anxiety, breast cancer, cancer, Breast cancer, depressive symptoms, depression
RECURRENCE, BREAST CANCER, CANCER, BREAST CANCER, SECONDARY, BLIND
Breast cancer patients with a moderate stress level were randomly assigned to a structured short-term psychotherapy (group A) or non-specific group discussion (group B) during breast cancer rehabilitation in Germany. Our study showed no difference between structured short-term psychotherapy and non-specific group discussions with respect to anxiety as the primary outcome and all other secondary outcomes in the primary analysis. However, our subgroup analysis showed signs, that participants in group A with high anxiety levels at baseline reported fewer depressive symptoms at the end of rehabilitation.Our study did not show any evidence of superiority of one of the two psychological interventions and is in accordance with a French randomized trial that evaluated the effects of a structured specific psychosocial intervention that included educational, cognitive behavioral therapy elements and reinforcement in eight sessions over a period of four weeks [The result of the subgroup analysis, in that breast cancer patients with high anxiety scores at baseline receiving structured short-term psychotherapy reported lower levels of depression than similar patients receiving unstructured non-specific group discussion, may also indicate that additional and structured psycho-oncological treatment in addition to psycho-oncological treatment in standard rehabilitation care may have added value in high-risk patients, only. This is in line with a German randomized controlled trial that showed that a short-term psycho-oncological intervention led to significant improvements in anxiety and depression only in a high risk group with high levels of anxiety and depression [The results of the current study must be interpreted in light of the following limitations. First, the third author had a dual role in that he was the study initiator and, at the same time, a psychotherapist alongside two trained physician psycho-oncologists who delivered the group intervention in groups A and B. This and the single-center setting limit generalizability of our results. Second, participants in both groups (group A and B) took part in weekly therapy sessions. Thus, there is no comparison with participants without an additional group intervention. A three-armed study with a second control group, which would have received only the common dose of psychological treatments specified in the German rehabilitation therapy standards, could have informed whether an additional short-term group has an additional benefit at all. Moreover, the overall treatment dose of 150 min of the short-term psychotherapy might not be sufficient to adequately describe and learn psychotherapeutic behavioral intervention techniques. Third, it was not feasible to blind patients and medical staff. Despite the highly standardized setting and the comparison with an active control group, it cannot be excluded that the patient-reported outcomes were influenced by patient and/or caregiver knowledge about the treatment. Fourth, generalization to other welfare systems and patient groups may be limited because of the intensive and highly standardized rehabilitation programs available for women with breast cancer in Germany. Fifth, no data were collected on how many patients were recommended psychotherapy in group A. This data could have generated important insights analyzing the aim of the structured short-term psychotherapy. Moreover, we did not assess further cancer-specific data on fear of progression and recurrence [Despite these limitations, our study had some strengths. First, the internal validity of the study was assured by its randomized design, which prevented selection bias and yielded comparable study groups. Second, the risk of performance bias was low due the standardized description of the structured psychotherapy, the same dose of treatment in group A and B, and the standardized performance of cancer rehabilitation in German in line with rehabilitation therapy standards.