"These findings warrant further research to develop the nurse navigation framework and to explore the potential translation of this intervention into clinical practice," according to the authors of the REBECCA study (NCT03254875).
Intervention with nurse navigation and symptom screening reduced symptoms of psychological distress among patients with breast cancer compared with standard care alone, although these reductions were not statistically significant, according to findings from the Rehabilitation After Breast Cancer (REBECCA) trial (NCT03254875).
At 12 months, the estimated effect of the REBECCA intervention on distress among patients was –0.51 (95% CI, –1.05 to 0.04; P = .07), and the effect size was –0.49. Investigators observed significant reductions in symptoms of depression at 6 months (estimated effect, –1.39; 95% CI, –2.33 to –0.44; P = .004; effect size, –0.27) and 12-month breast cancer-specific health-related quality of life (HRQOL; estimated effect, 4.03; 95% CI, 1.28-6.77; P = .004;effect size, 0.31) with REBECCA intervention.
REBECCA intervention elicited reductions that lacked statistical significance in symptoms of anxiety at both 6 months (estimated effect, –1.00; 95% CI, –1.95 to –0.06; P = .04; effect size, –0.21) and 12 months (estimated effect, –1.01; 95% CI, –1.97 to –0.04; P = .04; effect size, –0.21). Additionally, REBECCA intervention yielded benefits in patient activation at 18 months (estimated effect, 3.52; 95% CI, –0.09 to 7.12; P = .06; effect size, 0.25).
Among those with low patient activation, investigators reported significant reductions in distress at 6 months (estimated effect, –1.35; 95% CI, –2.21 to –0.49) and 12 months (estimated effect, –1.08; 95% CI, –1.95 to –0.22). The effects of REBECCA intervention were also more significant among patients 60 years or older, those with less education, and those with low social support. Additionally, 91% of patients discussed the issues that were important to them during sessions. Investigators observed no adverse effects in the trial.
“To our knowledge, this is the first trial to show the feasibility (through a simple triage approach) of systematically selecting patients with breast cancer who had psychological symptoms of distress and to offer them more comprehensive supportive care, with the nurse navigator actively supporting the patient in accessing health care services that are available within the health care system,” the study authors wrote. “These findings warrant further research to develop the nurse navigation framework and to explore the potential translation of this intervention into clinical practice.”
In the study, 3 project nurses randomly assigned patients 1:1 to standard care with or without the REBECCA intervention. Three nurses with at least 20 years of experience with different patient groups carried out REBECCA intervention, which involved manualized sessions designed to increase patient engagement, enhance patient attitude in symptom management, encourage use of rehabilitation services at a local rehabilitation center. Patients in both groups were able to receive usual care including regular treatment and nurse support when receiving chemotherapy and radiotherapy plus municipality-based rehabilitation.
The primary end point of the study was the REBECCA intervention’s impact on psychological distress. Secondary end points included anxiety, depression, HRQOL specific to breast cancer, fear of recurrence, sleep, cognitive function, health behavior, and need for support.
Patients 18 years and older with newly diagnosed primary breast cancer who received breast cancer surgery were eligible for enrollment on the study. Other inclusion criteria included being able to speak Danish, physically attend rehabilitation, and providing written informed consent.
Overall, 309 patients received treatment at Rigshospitalet in Copenhagen, Denmark from August 2017 to October 2019, which included 156 receiving REBECCA intervention and 153 receiving standard care. The mean patient age was 55.8 years in the REBECCA intervention group and 56.7 years in the standard care group at baseline.
In the intervention and standard care groups, respectively, most patients had more than 12 to 15 years of education (63% vs 62%), were employed (72% vs 65%), and received prior lumpectomy (51% vs 63%). Additionally, most patients in each group received adjuvant radiotherapy (67% vs 76%), adjuvant chemotherapy (47% vs 44%), and adjuvant endocrine therapy (76% vs 81%).
The mean distress score was 8.20 points in the intervention group compared with 8.22 points in the standard care group. Moreover, the mean anxiety scores at baseline were 10.67 vs 10.96, and the mean depression scores were 7.84 vs 8.34 in each respective group. These scores decreased over time.
According to the investigators, limitations included not meeting the recruitment goal of 130 patients in each group, which may limit the study’s power. Moreover, the investigators advised interpreting findings from the secondary interactions analyses with caution because they were exploratory in nature.
Reference
Bidstrup PE, Johansen C, Kroman N, et al. Effect of a nurse navigation intervention on mental symptoms in patients with psychological vulnerability and breast cancer: the REBECCA randomized clinical trial. JAMA Netw Open. 2023;6(6):e2319591. doi:10.1001/jamanetworkopen.2023.19591
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