Background: Distress in patients with cancer influences their quality of life. Worldwide, screening on distress with\nthe Distress Thermometer (DT) in patients with cancer is recommended. However, the effects of the use of the DT\non the psychosocial wellbeing of the patient are unknown. A study to assess the psychosocial consequences of the\nsystematic use of the DT and its discussion by a nurse as compared to the usual care provided to outpatients who\nare treated for primary breast cancer is needed.\nMethods/design: The effectiveness of a nurse-led intervention with the DT will be tested in a non-blinded\nrandomized controlled trial. Patients treated with curative intent for breast cancer will be recruited from the\nRadboud University Medical Center. The intervention consists of the DT together with discussion of the results\nwith the patient by a trained oncology nurse added to the usual care. Patients will be randomly allocated (1:1)\nto either receive usual care or the usual care plus the intervention. Primary outcome measure is global quality\nof life measured with the EORTC QLQ-C30. The functional and symptom scales of the EORTC QLQ-C30 and BR23,\nHospital Anxiety and Depression Scale, Impact of Event Scale, Illness Cognition Questionnaire and DT (baseline\nand final measurement only) will be used to measure secondary outcomes. Questionnaires are obtained in both\narms at baseline, after completion of each type of cancer treatment modality and during follow up, with a three\nand six months� interval during the first and second year respectively.\nDiscussion: This study will be the first randomized controlled longitudinal study about the effectiveness of the\nDT as nurse led-intervention. In case of proven effectiveness, future implementation and standardization of use\nof the DT as part of routine care will be recommended
Loading....