BREATH：基于网络的原发性乳腺癌后心理调整自我管理-一项多中心随机对照试验的结果。

BREATH: Web-Based Self-Management for Psychological Adjustment After Primary Breast Cancer--Results of a Multicenter Randomized Controlled Trial.

机构信息

All authors: Radboud university medical center, Nijmegen, the Netherlands.

出版信息

J Clin Oncol. 2015 Sep 1;33(25):2763-71. doi: 10.1200/JCO.2013.54.9386. Epub 2015 Jul 13.

DOI:10.1200/JCO.2013.54.9386

PMID:26169621

Abstract

PURPOSE

Early breast cancer survivors (BCSs) report high unmet care needs, and easily accessible care is not routinely available for this growing population. The Breast Cancer E-Health (BREATH) trial is a Web-based self-management intervention to support the psychological adjustment of women after primary treatment, by reducing distress and improving empowerment.

PATIENTS AND METHODS

This multicenter, randomized, controlled, parallel-group trial evaluated whether care as usual (CAU) plus BREATH is superior to CAU alone. BREATH is delivered in sixteen fully automated weekly modules covering early survivorship issues. Two to 4 months post-treatment, BCSs were randomly assigned to receive CAU + BREATH (n = 70) or CAU alone (n = 80) using a stratified block design (ratio 1:1). Primary outcomes were distress (Symptom Checklist-90) and empowerment (Cancer Empowerment Questionnaire), assessed before random assignment (baseline, T0) and after 4 (T1), 6 (T2), and 10 months (T3) of follow-up. Statistical (analysis of covariance) and clinical effects (reliable change index) were tested in an intention-to-treat analysis (T0 to T1). Follow-up effects (T0 to T3) were assessed in assessment completers.

RESULTS

CAU + BREATH participants reported significantly less distress than CAU-alone participants (-7.79; 95% CI, -14.31 to -1.27; P = .02) with a small-to-medium effect size (d = 0.33), but empowerment was not affected (-1.71; 95% CI, 5.20 to -1.79; P = .34). More CAU + BREATH participants (39 of 70 [56%]; 95% CI, 44.1 to 66.8) than CAU-alone participants (32 of 80 [40%]; 95% CI, 30.0 to 51.0) showed clinically significant improvement (P = .03). This clinical effect was most prominent in low-distress BCSs. Secondary outcomes confirmed primary outcomes. There were no between-group differences in primary outcomes during follow-up.

CONCLUSION

Access to BREATH reduced distress among BCSs, but this effect was not sustained during follow-up.

摘要

目的

早期乳腺癌幸存者（BCS）报告存在大量未满足的护理需求，而对于这一不断增长的群体，便捷的护理服务通常无法提供。Breast Cancer E-Health（BREATH）试验是一种基于网络的自我管理干预措施，旨在通过减轻困扰和提高赋权来支持女性在初级治疗后的心理调整。

患者和方法

这是一项多中心、随机、对照、平行组试验，评估了常规护理（CAU）加 BREATH 是否优于单独的 CAU。BREATH 通过十六个完全自动化的每周模块提供，涵盖早期生存问题。在治疗后 2 至 4 个月，BCSs 被随机分配接受 CAU+ BREATH（n = 70）或单独的 CAU（n = 80），使用分层块设计（比例为 1:1）。主要结局指标是困扰（症状清单 90）和赋权（癌症赋权问卷），在随机分配前（基线，T0）和 4（T1）、6（T2）和 10 个月（T3）随访时进行评估。在意向治疗分析（T0 至 T1）中测试了统计（协方差分析）和临床效果（可靠变化指数）。在评估完成者中评估了随访效果（T0 至 T3）。

结果

与单独接受 CAU 的参与者相比，接受 CAU+ BREATH 的参与者报告的困扰明显减少（-7.79；95%置信区间，-14.31 至-1.27；P =.02），具有小到中等的效应大小（d = 0.33），但赋权没有受到影响（-1.71；95%置信区间，5.20 至-1.79；P =.34）。与单独接受 CAU 的参与者（32 名[40%]；95%置信区间，30.0 至 51.0）相比，接受 CAU+ BREATH 的参与者（39 名[56%]；95%置信区间，44.1 至 66.8）中有更多的人表现出临床显著改善（P =.03）。这种临床效果在低困扰 BCS 中最为明显。次要结局证实了主要结局。在随访期间，两组在主要结局方面没有差异。