Boesen Ellen H, Boesen Sidsel H, Frederiksen Kirsten, Ross Lone, Dahlstrøm Karin, Schmidt Grethe, Naested Jesper, Krag Christen, Johansen Christoffer
Institute of Cancer Epidemiology, Danish Cancer Society, Strandboulevarden 49, DK-2100 Copenhagen, Denmark.
J Clin Oncol. 2007 Dec 20;25(36):5698-703. doi: 10.1200/JCO.2007.10.8894.
The results of a randomized, intervention study done in 1993 of psychoeducation for patients with early-stage malignant melanoma showed a beneficial effect on recurrence and survival 6 years after the intervention. In the present study, we replicated the study with 258 Danish patients with malignant melanoma. We also compared recurrence and survival among the participants in the randomized study with 137 patients who refused to participate.
We randomly assigned 262 patients with primary malignant melanoma to a control or an intervention group. Patients in the intervention group were offered six weekly 2-hour sessions of psychoeducation. Participants and nonparticipants were followed up for vital status and recurrence 4 to 6 years after surgical treatment. Prognostic factors (thickness of the tumor and lymph node status), sex, and age were adjusted for in a Cox regression model (proportional hazards regression) to derive an adjusted survival rate ratio and an adjusted relapse-free survival rate ratio, with 95% CIs.
The hazard ratio was 1.30 (95% CI, 0.5 to 3.5) for survival and 0.73 (95% CI, 0.3 to 1.9) for recurrence. Being a nonparticipant increased the risk for death by more than two-fold (hazard ratio, 2.26; 95% CI, 1.0 to 5.2) over that of participants.
Psychoeducation did not increase survival or the recurrence-free interval among patients with malignant melanoma; however, nonparticipants had a statistically significantly greater risk for death than participants.
1993年针对早期恶性黑色素瘤患者进行的一项随机干预性研究结果显示,干预6年后对复发和生存有有益影响。在本研究中,我们对258名丹麦恶性黑色素瘤患者重复了该研究。我们还比较了随机研究中参与者与137名拒绝参与者的复发和生存情况。
我们将262例原发性恶性黑色素瘤患者随机分为对照组或干预组。干预组患者接受为期六周、每周两小时的心理教育课程。对参与者和非参与者在手术治疗后4至6年进行生命状态和复发情况的随访。在Cox回归模型(比例风险回归)中对预后因素(肿瘤厚度和淋巴结状态)、性别和年龄进行调整,以得出调整后的生存率比值和调整后的无复发生存率比值,并给出95%置信区间。
生存的风险比为1.30(95%置信区间,0.5至3.5),复发的风险比为0.73(95%置信区间,0.3至1.9)。与参与者相比,非参与者的死亡风险增加了两倍多(风险比,2.26;95%置信区间,1.0至5.2)。
心理教育并未提高恶性黑色素瘤患者的生存率或无复发间隔时间;然而,非参与者的死亡风险在统计学上显著高于参与者。