Psychological Aspects of Cancer, Danish Cancer Society Research Center, Copenhagen, Denmark.
Department of Psychology, University of Copenhagen, Copenhagen, Denmark.
JAMA Netw Open. 2023 Jun 1;6(6):e2319591. doi: 10.1001/jamanetworkopen.2023.19591.
The unmet needs regarding symptom management of psychological distress among patients with breast cancer must be addressed. However, little evidence exists on effective interventions, such as nurse navigation.
To compare the long-term effects of the REBECCA (Rehabilitation After Breast Cancer) nurse navigation intervention vs usual care in patients with breast cancer who were psychologically vulnerable.
DESIGN, SETTING, AND PARTICIPANTS: This parallel randomized clinical trial recruited and evaluated for eligibility adult female patients with newly diagnosed breast cancer and symptoms of psychological distress (distress score of ≥7 points on Distress Thermometer) at Rigshospitalet in Copenhagen, Denmark, from August 2017 to October 2019. This study continued the work of a pilot study, extending the follow-up to 18 months. Patients who met the inclusion criteria were randomized to either standard care or the REBECCA intervention. Intention-to-treat analyses were performed from June 2021 to October 2022.
Patients who were randomized to the REBECCA intervention received nurse navigation and symptom screening as well as standard care. Standard care included regular treatment, nurse support at chemotherapy and radiotherapy appointments, and municipality-based rehabilitation.
The primary outcome was distress, as measured using the Distress Thermometer. The secondary outcomes included symptoms of anxiety, symptoms of depression, breast cancer-specific health-related quality of life, fear of recurrence, sleep, cognitive function, patient activation, pain, health behavior, body mass index, and need for support. Long-term effects at 6, 12, and 18 months were examined using mixed-effect models, adjusting for randomization strata of age and treatment modality.
A total of 309 female patients were included in the analysis, with 153 patients randomized to the standard care group and 156 patients randomized to the REBECCA intervention group. Mean (SD) age was 56 (11) years with only small between-group differences. Patients receiving the REBECCA intervention compared with standard care had reduced (although not significant) symptoms of distress, especially at the 12-month follow-up (estimated effect = -0.51 [95% CI, -1.05 to 0.04]; effect size [ES] = -0.49). Significant effects were seen for symptoms of depression at 6 months (estimated effect = -1.39 [95% CI, -2.33 to -0.44]; ES = -0.27), and breast cancer-specific health-related quality of life at 12 months (estimated effect = 4.03 [95% CI, 1.28- 6.77]; ES = 0.31). Nonsignificant reductions were seen for symptoms of anxiety at 6 months (estimated effect = -1.00 [95% CI, -1.95 to -0.06]; ES = -0.21) and 12 months (estimated effect = -1.01 [95% CI, -1.97 to -0.04]; ES = -0.21), and a nonsignificant increase was seen for patient activation at 18 months (estimated effect = 3.52 [95% CI, -0.09 to 7.12]; ES = 0.25). Stronger intervention effects were observed for younger age, low patient activation, less education, and low social support.
Results of this study indicate that patients with breast cancer who were psychologically vulnerable (ie, having moderate to high psychological distress) did not experience significant reduction in distress with nurse navigation. Further research is needed to develop the intervention's framework and investigate its potential use in clinical practice.
ClinicalTrials.gov Identifier: NCT03254875.
背景：乳腺癌患者的心理困扰症状管理存在未满足的需求，必须加以解决。然而，目前几乎没有有效的干预措施，例如护士导航。
目的：比较 REBECCA（乳腺癌康复）护士导航干预与乳腺癌心理脆弱患者常规护理的长期效果。
设计、地点和参与者：这是一项平行随机临床试验，在丹麦哥本哈根的 Rigshospitalet 招募并评估了新诊断为乳腺癌且有心理困扰症状（Distress Thermometer 得分≥7 分）的成年女性患者，时间为 2017 年 8 月至 2019 年 10 月。本研究延续了一项试点研究的工作，将随访时间延长至 18 个月。符合纳入标准的患者被随机分为标准护理组或 REBECCA 干预组。从 2021 年 6 月至 2022 年 10 月进行意向治疗分析。
干预措施：随机分配到 REBECCA 干预组的患者接受护士导航和症状筛查以及标准护理。标准护理包括常规治疗、化疗和放疗预约时的护士支持以及基于市的康复。
主要结果和措施：主要结局是使用 Distress Thermometer 测量的困扰。次要结局包括焦虑症状、抑郁症状、乳腺癌特定健康相关生活质量、复发恐惧、睡眠、认知功能、患者激活、疼痛、健康行为、体重指数和支持需求。使用混合效应模型，根据年龄和治疗方式的随机化分层，调整 6、12 和 18 个月的长期效果。
结果：共有 309 名女性患者纳入分析，其中 153 名患者随机分配到标准护理组，156 名患者随机分配到 REBECCA 干预组。平均（SD）年龄为 56（11）岁，两组之间只有很小的差异。与标准护理相比，接受 REBECCA 干预的患者的困扰症状（尽管不显著）有所减轻，尤其是在 12 个月的随访时（估计效果=-0.51 [95% CI，-1.05 至 0.04]；效应量[ES]=-0.49）。在 6 个月时观察到抑郁症状（估计效果=-1.39 [95% CI，-2.33 至 -0.44]；ES=-0.27）和 12 个月时乳腺癌特定健康相关生活质量（估计效果=4.03 [95% CI，1.28 至 6.77]；ES=0.31）有显著改善。在 6 个月和 12 个月时，焦虑症状（估计效果=-1.00 [95% CI，-1.95 至 -0.06]；ES=-0.21）和 12 个月时（估计效果=-1.01 [95% CI，-1.97 至 -0.04]；ES=-0.21）的改善不显著，18 个月时患者激活（估计效果=3.52 [95% CI，-0.09 至 7.12]；ES=0.25）略有增加。对于年龄较小、患者激活程度较低、教育程度较低和社会支持较低的患者，干预效果更强。
结论：这项研究的结果表明，患有心理脆弱的乳腺癌患者（即有中度至高度心理困扰）并未通过护士导航显著减轻困扰。需要进一步研究以开发该干预措施的框架，并研究其在临床实践中的潜在应用。
