Department of Psychology, The Ohio State University, Columbus, OH 43210, USA.
Clin Cancer Res. 2010 Jun 15;16(12):3270-8. doi: 10.1158/1078-0432.CCR-10-0278. Epub 2010 Jun 8.
A clinical trial was designed to test the hypothesis that a psychological intervention could reduce the risk of cancer recurrence. Newly diagnosed regional breast cancer patients (n = 227) were randomized to the intervention-with-assessment or the assessment-only arm. The intervention had positive psychological, social, immune, and health benefits, and after a median of 11 years the intervention arm was found to have reduced the risk of recurrence (hazard ratio, 0.55; P = 0.034). In follow-up, we hypothesized that the intervention arm might also show longer survival after recurrence. If observed, we then would examine potential biobehavioral mechanisms.
All patients were followed; 62 recurred. Survival analyses included all 62. Upon recurrence diagnosis, those available for further biobehavioral study were accrued (n = 41, 23 intervention and 18 assessment). For those 41, psychological, social, adherence, health, and immune (natural killer cell cytotoxicity, T-cell proliferation) data were collected at recurrence diagnosis and 4, 8, and 12 months later.
Intent-to-treat analysis revealed reduced risk of death following recurrence for the intervention arm (hazard ratio, 0.41; P = 0.014). Mixed-effects follow-up analyses with biobehavioral data showed that all patients responded with significant psychological distress at recurrence diagnosis, but thereafter only the intervention arm improved (P values < 0.023). Immune indices were significantly higher for the intervention arm at 12 months (P values < 0.017).
Hazards analyses augment previous findings in showing improved survival for the intervention arm after recurrence. Follow-up analyses showing biobehavioral advantages for the intervention arm contribute to our understanding of how improved survival was achieved.
一项临床试验旨在检验心理干预是否可以降低癌症复发风险的假设。新诊断的局部乳腺癌患者（n=227）被随机分为干预评估组或仅评估组。干预具有积极的心理、社会、免疫和健康益处，在中位数为 11 年的随访后，干预组被发现降低了复发风险（风险比，0.55；P=0.034）。在随访中，我们假设干预组在复发后也可能表现出更长的生存时间。如果观察到，我们将进一步研究潜在的生物行为机制。
所有患者均接受随访；62 例患者复发。生存分析包括所有 62 例患者。在复发诊断时，对可进一步进行生物行为学研究的患者进行入组（n=41，23 例干预组和 18 例评估组）。对于这 41 例患者，在复发诊断时以及 4、8 和 12 个月后收集了心理、社会、依从性、健康和免疫（自然杀伤细胞细胞毒性、T 细胞增殖）数据。
意向治疗分析显示，干预组复发后死亡风险降低（风险比，0.41；P=0.014）。对生物行为数据进行混合效应随访分析显示，所有患者在复发诊断时均出现明显的心理困扰，但此后仅干预组得到改善（P 值<0.023）。干预组在 12 个月时的免疫指数显著更高（P 值<0.017）。
危害分析增强了先前的发现，表明干预组在复发后具有更好的生存结果。后续分析显示，干预组在生物行为方面具有优势，有助于我们理解如何实现了更好的生存。
