成人脑转移瘤患者的癌症管理与有意义生活：一项美国国立卫生研究院ORBIT模型II期可行性和概念验证试验
Managing Cancer and Living Meaningfully in adults with brain metastases: A NIH ORBIT model phase II feasibility and proof-of-concept trial.
作者信息
Loughan Ashlee R, Lanoye Autumn, Willis Kelcie, Braun Sarah Ellen, Davies Alexandria, Rodin Gary, Thacker Leroy, Fox Amber, Kleva Christopher, Zarrella Giuliana, Mazzeo Suzanne, Svikis Dace, Swartz Leigh
机构信息
Massey Comprehensive Cancer Center, Richmond, Virginia, USA.
School of Medicine, Virginia Commonwealth University, Richmond, Virginia, USA.
出版信息
Neurooncol Pract. 2024 Oct 15;12(2):271-280. doi: 10.1093/nop/npae097. eCollection 2025 Apr.
BACKGROUND
Managing Cancer and Living Meaningfully (CALM) is a brief, evidence-based psychotherapy designed to help patients with advanced cancer cope with the practical and profound challenges of their illness. However, no study has systematically examined CALM in adults with brain metastases, despite the well-documented incidence of distress in this growing population. The primary aim of this trial was to assess the feasibility and acceptability of CALM in adults with brain metastases.
METHODS
Patients with brain metastases ( = 13) and elevated symptoms of depression and/or death anxiety enrolled in this single-arm trial. CALM was administered in 6 biweekly sessions, with outcomes assessed at baseline and post-intervention. Feasibility was assessed based on established metrics including enrollment and retention rates. Acceptability was measured by post-session surveys and post-intervention interviews. Preliminary signal change on measures of psychological distress was explored.
RESULTS
Of the 13 enrolled participants, 11 completed baseline assessments and initiated treatment: 73% female, = 58 years (SD = 12.9; range = 37-75). Nine completed the study (81% retention rate). Overall, participants reported high perceived benefits and would recommend the program to others. Baseline to post-intervention assessments indicated improvements in depression, death anxiety, generalized anxiety, post-traumatic stress, suicidal ideation, and spiritual well-being. Life quality, substance use, and fear of cancer recurrence remained relatively stable.
CONCLUSIONS
CALM is feasible and acceptable and may improve psychological distress in adults with brain metastases. The findings of this study align with our previous trial of patients with malignant glioma and support a future National Institute of Health Obesity Related Behavioral Intervention Trials phase II randomized pilot trial of CALM in neuro-oncology.
TRIAL REGISTRATION NUMBER
NCT05087095 registered on March 23, 2022.
背景
“管理癌症与有意义地生活”（CALM）是一种简短的、基于证据的心理治疗方法，旨在帮助晚期癌症患者应对疾病带来的实际且深刻的挑战。然而，尽管有充分记录表明这一不断增长的人群中存在痛苦情绪，但尚无研究系统地考察CALM对患有脑转移瘤的成年人的效果。本试验的主要目的是评估CALM对患有脑转移瘤的成年人的可行性和可接受性。
方法
患有脑转移瘤且抑郁和/或死亡焦虑症状加重的患者参加了这项单臂试验。CALM通过6次每两周一次的疗程进行实施，在基线和干预后评估结果。基于包括入组率和留存率在内的既定指标评估可行性。通过疗程后调查和干预后访谈衡量可接受性。探索心理困扰指标的初步信号变化。
结果
在13名入组参与者中，11名完成了基线评估并开始治疗：女性占73%，年龄中位数为58岁（标准差=12.9；范围=37 - 75岁）。9名完成了研究（留存率81%）。总体而言，参与者报告了较高的感知益处，并会向他人推荐该项目。从基线到干预后的评估表明，抑郁、死亡焦虑、广泛性焦虑、创伤后应激、自杀意念和精神幸福感均有所改善。生活质量、物质使用以及对癌症复发的恐惧保持相对稳定。
结论
CALM是可行且可接受的，可能改善患有脑转移瘤的成年人的心理困扰。本研究结果与我们之前对恶性胶质瘤患者的试验结果一致，并支持未来美国国立卫生研究院肥胖相关行为干预试验在神经肿瘤学领域开展CALM的II期随机试点试验。
试验注册号
NCT05087095，于2022年3月23日注册。
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