Does a regular nurse‐led distress screening and discussion improve quality of life of breast cancer patients treated with curative intent? A randomized controlled trial

Abstract
Objective We performed a randomized controlled trial (RCT) to investigate whether regular screening with the DT by a nurse improved global QOL of patients with breast cancer (BC) treated with curative intent. Methods BC patients were randomized between regular screening for distress with a nurse‐led DT intervention (NDTI) and usual care (UC). Both groups filled out questionnaires at baseline, after each received treatment modality and at follow‐up visits up to 2 years. At these points, the intervention group received also the NDTI. The primary outcome was the global QOL of the EORTC QLQ C30 at 2 years after end of treatment. Analyses were done on an intention‐to‐treat basis, using ANCOVA, generalized least squares, and interaction analyses. Results Of 194 randomized patients, 153 filled out the questionnaires up to 2 years after treatment. There was no significant difference between NDTI and UC in global QOL 2 years after end of treatment (mean diff. ‐1∙273, p=0∙610; 95% CI [‐6.195; 3∙649]). Subgroup analysis of patients who received multimodality treatment (surgery, radiotherapy, and chemotherapy, n=66) showed a significant between‐group difference in global QOL over time (mean diff. ‐10, p< 0∙001; 95% CI [‐14∙835; ‐5∙167]) together with other secondary outcomes measures in favor of the NDTI. Conclusion NDTI did not lead to a significant improvement in global QOL 2 years after end of treatment for patients with BC. However, the findings indicate that BC patients who received multimodality treatment, may benefit from NDTI.