Managing Cancer and Living Meaningfully in adults with brain metastases: A NIH ORBIT model phase II feasibility and proof-of-concept trial.

IF 2.5 Q2 CLINICAL NEUROLOGY

Neuro-oncology practice Pub Date : 2024-10-15 eCollection Date: 2025-04-01 DOI:10.1093/nop/npae097

Ashlee R Loughan, Autumn Lanoye, Kelcie Willis, Sarah Ellen Braun, Alexandria Davies, Gary Rodin, Leroy Thacker, Amber Fox, Christopher Kleva, Giuliana Zarrella, Suzanne Mazzeo, Dace Svikis, Leigh Swartz

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引用次数: 0

Abstract

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 (N = 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, M _age = 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.

查看原文本刊更多论文

管理癌症和有意义的生活在成人脑转移：NIH ORBIT模型II期可行性和概念验证试验。

背景：管理癌症和有意义的生活（CALM）是一个简短的，以证据为基础的心理治疗，旨在帮助晚期癌症患者应对他们疾病的实际和深刻的挑战。然而，尽管在这一不断增长的人群中有充分的文献记载，但没有研究系统地检查脑转移的成人镇静。该试验的主要目的是评估CALM在成人脑转移患者中的可行性和可接受性。方法：脑转移患者（N = 13）和抑郁和/或死亡焦虑症状升高纳入这项单臂试验。CALM分为6个双周疗程，在基线和干预后评估结果。可行性评估基于既定的指标，包括入学率和保留率。可接受性通过治疗后调查和干预后访谈来衡量。初步探讨了心理困扰措施的信号变化。结果：在13名入组参与者中，11名完成基线评估并开始治疗：73%为女性，M年龄= 58岁(SD = 12.9；范围= 37-75)。9人完成了研究（保留率81%）。总体而言，参与者报告了较高的感知收益，并将向其他人推荐该计划。干预后评估的基线显示抑郁、死亡焦虑、广泛性焦虑、创伤后应激、自杀意念和精神健康有所改善。生活质量、药物使用和对癌症复发的恐惧相对稳定。结论：CALM是可行和可接受的，可以改善成人脑转移患者的心理困扰。这项研究的结果与我们之前对恶性胶质瘤患者的试验结果一致，并支持未来国家健康研究所肥胖相关行为干预试验在神经肿瘤学中进行CALM的二期随机试验。试验注册号：NCT05087095，于2022年3月23日注册。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Neuro-oncology practice CLINICAL NEUROLOGY-

CiteScore

5.30

自引率

11.10%

发文量

期刊介绍： Neuro-Oncology Practice focuses on the clinical aspects of the subspecialty for practicing clinicians and healthcare specialists from a variety of disciplines including physicians, nurses, physical/occupational therapists, neuropsychologists, and palliative care specialists, who have focused their careers on clinical patient care and who want to apply the latest treatment advances to their practice. These include: Applying new trial results to improve standards of patient care Translating scientific advances such as tumor molecular profiling and advanced imaging into clinical treatment decision making and personalized brain tumor therapies Raising awareness of basic, translational and clinical research in areas of symptom management, survivorship, neurocognitive function, end of life issues and caregiving