Objective: We performed a randomized controlled trial (RCT) to investigate whether regular screening with the distress thermometer (DT) by a nurse improved global quality of life (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 the end of treatment. Analyses were done on an intention-to-treat basis, using analysis of covariance (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 the end of treatment (mean diff. = -1Á273, P = .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 < .001; 95% CI [−14.835; −5.167]) together with other secondary outcome measures in favor of the NDTI.Conclusion: NDTI did not lead to a significant improvement in global QOL 2 years after the end of treatment for patients with BC. However, the findings indicate that BC patients who received multimodality treatment may benefit from NDTI. K E Y W O R D S breast cancer, cancer, distress, distress screening, distress thermometer, nurse-led intervention, oncology, psychosocial intervention, quality of life, RCT naires were completed by the patients, and interventions deemed necessary were carried out (T1). Subsequently, if applicable, after the second treatment modality (T2) and third treatment modality (T3), again questionnaires were completed and necessary interventions were carried out. This was repeated every 3 months during the followup visits in the first year (T4-T7) and every 6 months during the second year of follow-up (T8-T9). This resulted in a total of 8 to 10 measurements for each patient, depending on the number of treatment modalities. These intervals were recommended by the Dutch Distress guideline and corresponded with the NCCN guideline. 1,24 Three oncology nurses (study nurses) were responsible for collecting data.
| InterventionThe NDTI comprised a discussion of the DT results by a study nurse according the Dutch distress guideline. 24 Three qualified oncology nurses were trained in how to use the DT to become study nurses for this study. After each assessment, the nurse reviewed the DT score and explored which problems were particularly important to the patient. The intervention encompassed providing emotional support and education about cancer and its treatment. It also included giving practical advice on emotional, social, pra...