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在早期黑色素瘤随访中采用皮肤自我检查及癌症复发恐惧管理:MELACARE干预措施在一项随机对照试验中的评估

Employing skin self-examination and fear of cancer recurrence management in early-stage melanoma follow-up: evaluation of the MELACARE intervention in a randomised controlled trial.

作者信息

Hansen Sara Mølgaard, Johansen Christoffer, Kasparian Nadine A, Grand Mia Klinten, Bidstrup Pernille Envold, Hölmich Lisbet Rosenkrantz

机构信息

Department of Plastic Surgery, Copenhagen University Hospital, Herlev and Gentofte Hospital, Herlev, Denmark.

Department of Oncology, Cancer Survivorship and Late Effects Research Center (CASTLE), Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.

出版信息

J Cancer Surviv. 2025 Jun 12. doi: 10.1007/s11764-025-01841-1.

DOI:10.1007/s11764-025-01841-1
PMID:40504479
Abstract

PURPOSE

The MELACARE intervention aimed to evaluate a nurse-led follow-up program incorporating skin self-examination (SSE) education and psychosocial support to address fear of cancer recurrence (FCR) in early-stage melanoma survivors. This study assessed the MELACARE intervention's impact on FCR, psychological well-being, SSE performance, and healthcare usage compared to standard physician-led follow-up.

METHODS

A two-group randomised controlled trial was conducted at Herlev and Gentofte Hospital, Denmark. Participants included 153 patients with surgically treated melanoma (stages IA-IIA). Patients were randomised to either the MELACARE intervention (n = 78) or a control group provided treatment as usual (n = 75). The intervention involved nurse-led sessions focusing on SSE techniques and metacognitive strategies. Outcomes included FCR (primary), distress, anxiety, depression, health-related quality of life (HRQoL), patient activation, and SSE frequency and confidence (secondary) at 6 months.

TRIAL REGISTRATION

ClinicalTrials.gov (NCT05253872).

RESULTS

At 6 months, the mean of the primary outcome FCR was lower in the intervention compared to the control groups, but the difference was not statistically significant (- 0.86 [- 3.34;1.62]). Intervention patients reported higher HRQoL (18% [3;32]) and patient activation (0.43 [0.15;0.71]) as the only significant secondary outcomes. Confidence in SSE was higher in the intervention group, with most performing SSE at recommended intervals.

CONCLUSIONS

The MELACARE intervention may improve HRQoL and patient activation but did not reduce FCR. High fidelity of delivery and patient adherence highlight its potential utility.

IMPLICATIONS FOR CANCER SURVIVORS

The MELACARE approach empowers melanoma survivors through structured SSE education and psychosocial support. Future analyses will investigate long-term safety and efficacy.

摘要

目的

MELACARE干预旨在评估一项由护士主导的随访项目,该项目纳入皮肤自我检查(SSE)教育和心理社会支持,以解决早期黑色素瘤幸存者对癌症复发的恐惧(FCR)。本研究评估了MELACARE干预与标准的医生主导随访相比,对FCR、心理健康、SSE表现和医疗保健使用的影响。

方法

在丹麦的Herlev和Gentofte医院进行了一项两组随机对照试验。参与者包括153例接受手术治疗的黑色素瘤患者(IA-IIA期)。患者被随机分为MELACARE干预组(n = 78)或接受常规治疗的对照组(n = 75)。干预包括由护士主导的课程,重点是SSE技术和元认知策略。结局包括6个月时的FCR(主要结局)、痛苦、焦虑、抑郁、健康相关生活质量(HRQoL)、患者参与度,以及SSE频率和信心(次要结局)。

试验注册

ClinicalTrials.gov(NCT05253872)。

结果

在6个月时,干预组的主要结局FCR平均值低于对照组,但差异无统计学意义(-0.86 [-3.34;1.62])。干预组患者报告的HRQoL更高(18% [3;32]),患者参与度更高(0.43 [0.15;0.71]),这是仅有的显著次要结局。干预组对SSE的信心更高,大多数患者按推荐间隔进行SSE。

结论

MELACARE干预可能改善HRQoL和患者参与度,但并未降低FCR。高保真的实施和患者依从性突出了其潜在效用。

对癌症幸存者的意义

MELACARE方法通过结构化的SSE教育和心理社会支持增强黑色素瘤幸存者的能力。未来的分析将调查长期安全性和疗效。

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本文引用的文献

1
MELACARE Nurse-led follow-up after early-stage melanoma: protocol and feasibility.MELACARE 护士主导的早期黑色素瘤随访:方案和可行性。
Acta Oncol. 2024 Nov 24;63:909-914. doi: 10.2340/1651-226X.2024.41037.
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Lived Experiences and Fear of Cancer Recurrence Among Survivors of Localized Cutaneous Melanoma.局限性皮肤黑色素瘤幸存者的生活体验和对癌症复发的恐惧。
JAMA Dermatol. 2024 May 1;160(5):495-501. doi: 10.1001/jamadermatol.2023.6158.
3
Stage-Specific Risk of Recurrence and Death From Melanoma in Denmark, 2008-2021: A National Observational Cohort Study of 25 720 Patients With Stage IA to IV Melanoma.
丹麦 2008-2021 年黑色素瘤的特定分期复发和死亡风险:一项 25720 例 IA 至 IV 期黑色素瘤患者的全国观察性队列研究。
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4
The Achieving Self-directed Integrated Cancer Aftercare Intervention for Detection of Recurrent and Second Primary Melanoma in Survivors of Melanoma: Pilot Randomized Controlled Trial.黑色素瘤幸存者复发性和第二原发性黑色素瘤检测的自我导向综合癌症后续护理干预措施:试点随机对照试验。
JMIR Cancer. 2022 Sep 8;8(3):e37539. doi: 10.2196/37539.
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European consensus-based interdisciplinary guideline for melanoma. Part 1: Diagnostics: Update 2022.欧洲基于共识的多学科黑色素瘤指南。第 1 部分:诊断:2022 年更新。
Eur J Cancer. 2022 Jul;170:236-255. doi: 10.1016/j.ejca.2022.03.008. Epub 2022 May 12.
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Fear of Cancer Recurrence and Its Negative Impact on Health-Related Quality of Life in Long-term Breast Cancer Survivors.乳腺癌幸存者对癌症复发的恐惧及其对健康相关生活质量的负面影响。
Cancer Res Treat. 2022 Oct;54(4):1065-1073. doi: 10.4143/crt.2021.835. Epub 2021 Dec 8.
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Assessing the Potential for Patient-led Surveillance After Treatment of Localized Melanoma (MEL-SELF): A Pilot Randomized Clinical Trial.评估局部黑色素瘤(MEL-SELF)治疗后患者主导监测的潜力:一项试点随机临床试验。
JAMA Dermatol. 2022 Jan 1;158(1):33-42. doi: 10.1001/jamadermatol.2021.4704.
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The impact of fear of cancer recurrence on healthcare utilization among long-term breast cancer survivors recruited through ECOG-ACRIN trials.ECOG-ACRIN 试验招募的长期乳腺癌幸存者中,对癌症复发的恐惧对医疗保健利用的影响。
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