Purpose Fear of cancer recurrence (FCR) is prevalent, distressing, and long lasting. This study evaluated the impact of a theoretically/empirically based intervention (ConquerFear) on FCR. Methods Eligible survivors had curable breast or colorectal cancer or melanoma, had completed treatment (not including endocrine therapy) 2 months to 5 years previously, were age > 18 years, and had scores above the clinical cutoff on the FCR Inventory (FCRI) severity subscale at screening. Participants were randomly assigned at a one-to-one ratio to either five face-to-face sessions of ConquerFear (attention training, metacognitions, acceptance/mindfulness, screening behavior, and values-based goal setting) or an attention control (Taking-it-Easy relaxation therapy). Participants completed questionnaires at baseline (T0), immediately post-therapy (T1), and 3 (T2) and 6 months (T3) later. The primary outcome was FCRI total score. Results Of 704 potentially eligible survivors from 17 sites and two online databases, 533 were contactable, of whom 222 (42%) consented; 121 were randomly assigned to intervention and 101 to control. Study arms were equivalent at baseline on all measured characteristics. ConquerFear participants had clinically and statistically greater improvements than control participants from T0 to T1 on FCRI total ( P < .001) and severity subscale scores ( P = .001), which were maintained at T2 ( P = .017 and P = .023, respectively) and, for FCRI total only, at T3 ( P = .018), and from T0 to T1 on three FCRI subscales (coping, psychological distress, and triggers) as well as in general anxiety, cancer-specific distress (total), and mental quality of life and metacognitions (total). Differences in FCRI psychological distress and cancer-specific distress (total) remained significantly different at T3. Conclusion This randomized trial demonstrated efficacy of ConquerFear compared with attention control (Taking-it-Easy) in reduction of FCRI total scores immediately post-therapy and 3 and 6 months later and in many secondary outcomes immediately post-therapy. Cancer-specific distress (total) remained more improved at 3- and 6-month follow-up.

中文翻译：

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ConquerFear 的随机试验：一种新颖的、基于理论的心理社会干预措施，可消除癌症复发的恐惧

目的 对癌症复发 (FCR) 的恐惧普遍存在、令人痛苦且持久。本研究评估了基于理论/经验的干预 (ConquerFear) 对 FCR 的影响。方法 符合条件的幸存者患有可治愈的乳腺癌或结直肠癌或黑色素瘤，在 2 个月至 5 年前完成治疗（不包括内分泌治疗），年龄 > 18 岁，并且在 FCR 量表 (FCRI) 严重度分量表上的评分高于临床临界值在筛选。参与者以一对一的比例随机分配到 ConquerFear 的五个面对面课程（注意力训练、元认知、接受/正念、筛选行为和基于价值观的目标设定）或注意力控制（采取- it-Easy 放松疗法）。参与者在基线 (T0)、治疗后立即 (T1) 完成问卷，3 (T2) 和 6 个月 (T3) 后。主要结果是 FCRI 总分。结果 在来自 17 个站点和两个在线数据库的 704 名可能符合条件的幸存者中，533 名可以联系，其中 222 名 (42%) 同意；121 人被随机分配到干预组，101 人被随机分配到控制组。研究组在所有测量特征的基线上是等效的。ConquerFear 参与者在 FCRI 总分 ( P < .001) 和严重性分量表评分 ( P = .001) 方面，从 T0 到 T1 的临床和统计学上的改善都比对照参与者更大，这些改善保持在 T2 ( P = .017 和 P = .023 ，分别）和仅针对 FCRI 总数，在 T3 ( P = .018) 和从 T0 到 T1 的三个 FCRI 分量表（应对、心理困扰和触发因素）以及一般焦虑、癌症特定的困扰（总), 和精神生活质量和元认知（总计）。FCRI 心理困扰和癌症特异性困扰（总）的差异在 T3 时仍然存在显着差异。结论 这项随机试验证明了 ConquerFear 与注意力控制 (Taking-it-Easy) 相比在治疗后立即和 3 个月和 6 个月后降低 FCRI 总分以及治疗后立即降低许多次要结果方面的功效。在 3 个月和 6 个月的随访中，癌症特定的痛苦（总）仍然有更大的改善。结论 这项随机试验证明了 ConquerFear 与注意力控制 (Taking-it-Easy) 相比在治疗后立即和 3 个月和 6 个月后降低 FCRI 总分以及治疗后立即降低许多次要结果方面的功效。在 3 个月和 6 个月的随访中，癌症特定的痛苦（总）仍然有更大的改善。结论 这项随机试验证明了 ConquerFear 与注意力控制 (Taking-it-Easy) 相比在治疗后立即和 3 个月和 6 个月后降低 FCRI 总分以及治疗后立即降低许多次要结果方面的功效。在 3 个月和 6 个月的随访中，癌症特定的痛苦（总）仍然有更大的改善。