Robinson June K, Wayne Jeffrey D, Martini Mary C, Hultgren Brittney A, Mallett Kimberly A, Turrisi Rob
Department of Dermatology, Northwestern University Feinberg School of Medicine, Chicago, Illinois2Editor, JAMA Dermatology.
Division of Gastrointestinal & Oncologic Surgery, Department of Surgery, Northwestern University Feinberg School of Medicine, Chicago, Illinois.
JAMA Dermatol. 2016 Sep 1;152(9):979-85. doi: 10.1001/jamadermatol.2016.1985.
More than 1 million patients with melanoma in the United States are at risk to develop a second primary melanoma. Early detection of melanoma improves survival. Patients with melanoma may be able to self-manage care with their skin-check partners ("partners") and alert the physician when a concerning lesion is identified, thus providing an important adjunct to yearly skin examinations by a physician.
To evaluate the effect of a structured skin self-examination (SSE) intervention for patients with melanoma and their partners ("dyads") on SSE performance and the detection of new melanomas by the dyad or the physician.
DESIGN, SETTING, AND PARTICIPANTS: Randomized clinical trial with 24-month follow-up assessments. Patients with stage 0 to IIB melanoma and their skin-check partners participated from June 6, 2011, to April 24, 2015.
Dyads of patients and their partners were randomly assigned to receive the skills training intervention or customary care (control group).
The main outcome was frequency of SSE performance. The secondary outcome was detection of a new or recurrent melanoma by the dyad or physician. The tertiary outcome was the number of unscheduled physician appointments for concerning lesions.
The study cohort comprised 494 participants. The patient population was 51.2% (253 of 494) female and had a mean (SD) age of 55 (10) years. Patients in the intervention arms had significantly increased SSEs with their partners at 4, 12, and 24 months (P < .001 for all) compared with the control group (mean differences, 1.57 [95% CI, 1.29-1.85], 0.72 [95% CI, 0.39-1.06], and 0.94 [95% CI, 0.58-1.30], respectively). Patients in the intervention arms identified new melanomas more than those in the control group (χ21 = 28.77, P < .01 [n = 51 melanomas in situ] and χ21 = 6.43, P < .05 [n = 18 invasive melanomas]) and did not increase physician visits.
Patients with melanoma and their partners reliably performed SSE after participating in a structured skills training program lasting approximately 30 minutes, with reinforcement every 4 months by the study dermatologist. Accurate SSE by those at risk to develop melanoma may enhance early detection and relieve some of the burden on health services to provide continuing follow-up to a growing population of eligible patients.
clinicaltrials.gov Identifier: NCT01432860.
美国有超过100万黑色素瘤患者有发生第二原发性黑色素瘤的风险。黑色素瘤的早期检测可提高生存率。黑色素瘤患者或许能够与他们的皮肤检查伙伴（“伙伴”）自行管理护理，并在发现可疑病变时提醒医生，从而为医生每年进行的皮肤检查提供重要辅助。
评估针对黑色素瘤患者及其伙伴（“配对组”）的结构化皮肤自我检查（SSE）干预对SSE执行情况以及配对组或医生发现新黑色素瘤的影响。
设计、背景和参与者：进行为期24个月随访评估的随机临床试验。0至IIB期黑色素瘤患者及其皮肤检查伙伴于2011年6月6日至2015年4月24日参与试验。
将患者及其伙伴配对组随机分配接受技能培训干预或常规护理（对照组）。
主要结局是SSE执行频率。次要结局是配对组或医生发现新的或复发性黑色素瘤。第三结局是因可疑病变进行的非计划内医生预约次数。
研究队列包括494名参与者。患者群体中女性占51.2%（494名中的253名），平均（标准差）年龄为55（10）岁。与对照组相比，干预组患者在4个月、12个月和24个月时与伙伴进行的SSE显著增加（所有P值均<0.001）（平均差异分别为1.57[95%CI，1.29 - 1.85]、0.72[95%CI，0.39 - 1.06]和0.94[95%CI，0.58 - 1.30]）。干预组患者发现的新黑色素瘤比对照组多（原位黑色素瘤χ21 = 28.77，P < 0.01[n = 51例]，侵袭性黑色素瘤χ21 = 6.43，P < 0.05[n = 18例]），且未增加医生就诊次数。
黑色素瘤患者及其伙伴在参加了一个持续约30分钟的结构化技能培训项目后，能够可靠地进行SSE，研究皮肤科医生每4个月进行强化指导。有发生黑色素瘤风险的人群进行准确的SSE可能会提高早期检测率，并减轻卫生服务机构为越来越多符合条件的患者提供持续随访的部分负担。
clinicaltrials.gov标识符：NCT01432860
