The impact of a nurse navigation program on health, economic and medical outcomes of cancer patients in Saxony – a multicenter, prospective, randomized controlled trial

BACKGROUND: Cancer patients frequently experience complex psychosocial and informational needs that are challenging to address within fragmented healthcare environments, resulting in care inefficiencies and patient distress. Nurse navigation programs aim to provide structured, continuous coordination. This randomized controlled trial evaluated the effect of a nurse navigator program ("Onkolotse") on hospitalization rates, health-related quality of life, psychological burden, and direct hospital costs in Saxony, Germany. METHODS: In a prospective, multicenter, randomized controlled parallel-group trial across six certified hospital centers, 258 adult cancer patients were randomly allocated (1:1) to an intervention group receiving 12 months of nurse navigator support or a control group receiving standard guideline-based care. The primary endpoint was the 12-month hospitalization rate (≥ 1 additional inpatient stay with at least one overnight stay). Sensitivity analyses evaluated complete cases and alternative deterministic assumptions for missing hospitalization data. Secondary endpoints included anxiety and depression (HADS-D). Exploratory endpoints included health literacy (HLS-EU-Q16), health-related quality of life (SF-36), social support (MOS-SSS), and hospital costs documented by hospital medical controlling. RESULTS: Between October 2017 and December 2022, 258 patients were randomized (intervention: n = 132; control: n = 126). The trial was stopped prematurely following an interim analysis due to slow accrual. In the primary ITT analysis (assuming missing follow-ups as non-hospitalized), the hospitalization rate was 43.9% (58/132; 95% CI [35.3%, 52.8%]) in the intervention group versus 51.6% (65/126; 95% CI [42.5%, 60.6%]) in the control group (odds ratio [OR] = 0.74, 95% CI [0.45, 1.20]; p = 0.219). In the complete-case analysis (n = 192), hospitalization rates were 61.1% (58/95; 95% CI [50.5%, 70.9%]) in the intervention group and 67.0% (65/97; 95% CI [56.7%, 76.2%]) in the control group (OR = 0.77, 95% CI [0.43, 1.40]; p = 0.390). Between-group differences in 12-month HADS-D anxiety change (-0.75, 95% CI [-1.65, 0.15]; p = 0.103) and depression change (-0.56, 95% CI [-1.47, 0.35]; p = 0.225) were not statistically significant. Inpatient hospital costs did not differ significantly between groups (median: 14.224 Euro vs. 12.560 Euro; p = 0.136). CONCLUSION: The nurse navigator intervention did not demonstrate statistically significant reductions in hospitalization rates, psychological burden, or hospital costs in this underpowered trial. Nevertheless, high patient and physician satisfaction and descriptive outcome patterns indicate that nurse navigation may be a relevant supportive care approach for further evaluation in adequately powered studies using comprehensive healthcare utilization or claims data. TRIAL REGISTRATION: Trial registry name: German Clinical Trials Register (DRKS). REGISTRATION NUMBER: DRKS00013199. URL: https://www.drks.de/search/de/trial/DRKS00013199/details . Date of registration: 27 October 2017. Furthermore, the study design was published prior to the start of patient enrollment. This took place at the 16th German Congress for Health Services Research (DKVF) on September 26, 2017 [26].