Dieng M, Morton R L, Costa D S J, Butow P N, Menzies S W, Lo S, Mann G J, Cust A E, Kasparian N A
NHMRC Clinical Trials Centre, The University of Sydney, NSW, Australia.
Cancer Epidemiology and Prevention Research, Sydney School of Public Health, The University of Sydney, NSW, Australia.
Br J Dermatol. 2020 Apr;182(4):860-868. doi: 10.1111/bjd.17990. Epub 2019 Jul 25.
People with melanoma want and need effective interventions for living with fear of cancer recurrence (FCR).
This study reports the 12-month outcomes of a brief, psychological intervention designed to reduce FCR in people at high risk of developing another primary melanoma compared with usual care.
In this two-arm randomized controlled trial, adults previously diagnosed with stage 0, I or II melanoma were randomly allocated to the intervention (n = 80) or control (usual care) arm (n = 84). The trial was registered with the Australian and New Zealand Clinical Trials Registry on 19 March 2013 (registration: ACTRN12613000304730). The intervention comprised a 76-page psychoeducational resource and three individually tailored, telephone-based sessions with a psychologist, scheduled at specific time points around participants' dermatological appointments. The primary outcome was the level of self-reported fear of new or recurrent melanoma assessed at 12 months postintervention using the severity subscale of the Fear of Cancer Recurrence Inventory.
Compared with the control arm, the intervention group reported significantly lower FCR at 12 months postintervention; the between-group mean difference was -1·41 for FCR severity [95% confidence interval (CI) -2·6 to -0·2; P = 0·02] and -1·32 for FCR triggers (95% CI -2·6 to -0·02; P = 0·04). The odds ratio for FCR severity scores ≥13 (54% intervention, 63% control) was 0·59 (95% CI 0·30-1·14, P = 0·12). There were no differences between groups in secondary outcomes, such as anxiety, depression or health-related quality of life.
The previously reported 6-month benefits of this brief, patient-centred psychological intervention in reducing FCR were found to continue 12 months postintervention, with no known adverse effects, supporting implementation as part of routine melanoma care.
黑色素瘤患者希望并需要有效的干预措施来应对对癌症复发的恐惧（FCR）。
本研究报告了一种简短心理干预措施的12个月效果，该干预旨在降低与常规护理相比有发生另一种原发性黑色素瘤高风险人群的FCR。
在这项双臂随机对照试验中，先前被诊断为0期、I期或II期黑色素瘤的成年人被随机分配至干预组（n = 80）或对照组（常规护理）（n = 84）。该试验于2013年3月19日在澳大利亚和新西兰临床试验注册中心注册（注册号：ACTRN12613000304730）。干预措施包括一份76页的心理教育资料以及与一名心理学家进行的三次个性化的电话咨询，咨询安排在参与者皮肤科预约的特定时间点。主要结局是使用癌症复发恐惧量表的严重程度子量表在干预后12个月评估的自我报告的对新发或复发性黑色素瘤的恐惧程度。
与对照组相比，干预组在干预后12个月报告的FCR显著更低；FCR严重程度的组间平均差异为 -1.41 [95%置信区间（CI）-2.6至 -0.2；P = 0.02]，FCR触发因素的组间平均差异为 -1.32（95% CI -2.6至 -0.02；P = 0.04）。FCR严重程度评分≥13的比值比（干预组54%，对照组63%）为0.59（95% CI 0.30 - 1.14，P = 0.12）。在次要结局方面，如焦虑、抑郁或健康相关生活质量，两组之间没有差异。
先前报告的这种简短的、以患者为中心的心理干预在降低FCR方面6个月的益处被发现干预后12个月仍持续存在，且无已知不良影响，支持将其作为黑色素瘤常规护理的一部分实施。
