Background: Radiotherapy for localised prostate cancer has many known and distressing side effects. The efficacy\nof group interventions for reducing psychological morbidity is lacking. This study investigated the relative benefits\nof a group nurse-led intervention on psychological morbidity, unmet needs, treatment-related concerns and\nprostate cancer-specific quality of life in men receiving curative intent radiotherapy for prostate cancer.\nMethods: This phase III, two-arm cluster randomised controlled trial included 331 men (consent rate: 72 %; attrition:\n5 %) randomised to the intervention (n = 166) or usual care (n = 165). The intervention comprised four group and\none individual consultation all delivered by specialist uro-oncology nurses. Primary outcomes were anxious and\ndepressive symptoms as assessed by the Hospital Anxiety and Depression Scale. Unmet needs were assessed with\nthe Supportive Care Needs Survey-SF34 Revised, treatment-related concerns with the Cancer Treatment Scale and\nquality of life with the Expanded Prostate Cancer Index âË?â??26. Assessments occurred before, at the end of and 6\nmonths post-radiotherapy. Primary outcome analysis was by intention-to-treat and performed by fitting a linear\nmixed model to each outcome separately using all observed data.\nResults: Mixed models analysis indicated that group consultations had a significant beneficial effect on one of two\nprimary endpoints, depressive symptoms (p = 0.009), and one of twelve secondary endpoints, procedural concerns\nrelated to cancer treatment (p = 0.049). Group consultations did not have a significant beneficial effect on\ngeneralised anxiety, unmet needs and prostate cancer-specific quality of life.\nConclusions: Compared with individual consultations offered as part of usual care, the intervention provides a\nmeans of delivering patient education and is associated with modest reductions in depressive symptoms and\nprocedural concerns. Future work should seek to confirm the clinical feasibility and cost-effectiveness of group\ninterventions.
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