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评估一项针对卵巢癌幸存者癌症复发恐惧的自我引导式数字干预措施(“我战胜恐惧”)的效果:一项随机对照的试点等候名单试验。

Assessing the impact of a self-guided digital intervention for fear of cancer recurrence (iConquerFear) in ovarian cancer survivors: a pilot randomised waitlist-controlled trial.

作者信息

Wu Verena S, Smith Allan 'Ben', Russell Hayley, Bamgboje-Ayodele Adeola, Beatty Lisa, Pearce Alison, Dhillon Haryana, Shaw Joanne, Antony Jan, Fardell Joanna, Pangeni Anupama, Dixon Cyril, Rincones Orlando, Langdon Laura, Costa Daniel, Girgis Afaf

机构信息

The Daffodil Centre, The University of Sydney, A Joint Venture with Cancer Council NSW, Sydney, NSW, Australia.

South West Sydney Clinical Campuses, UNSW Medicine & Health, UNSW Sydney, Sydney, Australia.

出版信息

BMC Cancer. 2025 Mar 23;25(1):527. doi: 10.1186/s12885-025-13639-6.

DOI:10.1186/s12885-025-13639-6
PMID:40122804
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11929991/
Abstract

BACKGROUND

Approximately 50% of ovarian cancer (OC) survivors report fear of cancer recurrence/progression (FCR/P) as the most challenging aspect of living with cancer. This pilot, randomised waitlist-controlled trial aimed to evaluate the feasibility, acceptability, and safety of iConquerFear, a self-guided online FCR intervention for OC survivors.

METHODS

Stage I-III OC survivors were recruited via Ovarian Cancer Australia (OCA) between October-December 2022. Participants were randomised to access iConquerFear immediately (intervention) or after 8 weeks (waitlist-control). Primary outcomes were feasibility, acceptability, and safety. Secondary outcomes included: engagement barriers/enablers, perceived impact of iConquerFear, and suggested improvements via semi-structured interviews. Exploratory outcomes included group differences in FCR and FoP after iConquerFear use.

RESULTS

Of 62 eligible survivors, 55 (61%) were randomised (intervention n = 29; control n = 26). At baseline 55% (30/55) reported severe FCR (FCRI-SF ≥ 22). Of those randomised, 51% (n = 28) accessed iConquerFear; 16/28 (57%) users completed ≥ 3/5 modules. Mean post-intervention acceptability score (IEUQ) was 3/4 (SD = 0.8). Three (11%) users withdrew due to distress from iConquerFear. Qualitative interviews (n = 13) identified 6 key themes (e.g., participant factors influencing engagement). Differences between intervention and control group changes in FCR/P were non-significant.

CONCLUSIONS

iConquerFear does not appear appropriate for OC survivors in its current format due to limited engagement, varied acceptability, safety concerns and minimal group differences in FCR/P after iConquerFear use. More work is needed regarding how to augment online interventions addressing sensitive issues such as FCR/P in OC survivors (e.g., offering complementary in-person support) to ensure feasibility, acceptability and safety.

TRIAL REGISTRATION

This trial is registered with ANZCTR.org (ACTRN12622000592741p) on 21 April 2022.

摘要

背景

约50%的卵巢癌(OC)幸存者表示,害怕癌症复发/进展(FCR/P)是患癌后生活中最具挑战性的方面。这项先导性随机等待列表对照试验旨在评估“我战胜恐惧”(iConquerFear)的可行性、可接受性和安全性。“我战胜恐惧”是一项针对OC幸存者的自我引导式在线FCR干预措施。

方法

2022年10月至12月期间,通过澳大利亚卵巢癌协会(OCA)招募了I - III期OC幸存者。参与者被随机分为立即使用“我战胜恐惧”(干预组)或8周后使用(等待列表对照组)。主要结局指标为可行性、可接受性和安全性。次要结局指标包括:参与障碍/促进因素、对“我战胜恐惧”的感知影响以及通过半结构化访谈提出的改进建议。探索性结局指标包括使用“我战胜恐惧”后FCR和恐惧进展(FoP)的组间差异。

结果

在62名符合条件的幸存者中,55名(61%)被随机分组(干预组n = 29;对照组n = 26)。基线时,55%(30/55)报告有严重的FCR(FCRI - SF≥22)。在随机分组的人中,51%(n = 28)使用了“我战胜恐惧”;28名使用者中有16名(57%)完成了≥3/5个模块。干预后平均可接受性得分(IEUQ)为3/4(标准差= 0.8)。3名(11%)使用者因“我战胜恐惧”带来的困扰而退出。定性访谈(n = 13)确定了6个关键主题(例如,影响参与度的参与者因素)。干预组和对照组在FCR/P变化方面的差异不显著。

结论

由于参与度有限、可接受性各异、存在安全问题以及使用“我战胜恐惧”后FCR/P的组间差异极小,“我战胜恐惧”目前的形式似乎不适合OC幸存者。对于如何加强针对OC幸存者中FCR/P等敏感问题的在线干预措施(例如,提供补充性的面对面支持),以确保可行性、可接受性和安全性,还需要开展更多工作。

试验注册

本试验于2022年4月21日在ANZCTR.org(ACTRN12622000592741p)注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3342/11929991/cd7a597fa70e/12885_2025_13639_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3342/11929991/2c703f4e1450/12885_2025_13639_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3342/11929991/cd7a597fa70e/12885_2025_13639_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3342/11929991/2c703f4e1450/12885_2025_13639_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3342/11929991/cd7a597fa70e/12885_2025_13639_Fig2_HTML.jpg

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本文引用的文献

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