Lifestyle coaching is feasible in fatigued brain tumor patients: A phase I/feasibility, multi-center, mixed-methods randomized controlled trial.

IF 2.4 Q2 CLINICAL NEUROLOGY

Neuro-oncology practice Pub Date : 2022-10-14 eCollection Date: 2023-06-01 DOI:10.1093/nop/npac086

Alasdair G Rooney, William Hewins, Amie Walker, Mairi Mackinnon, Lisa Withington, Sara Robson, Claire Torrens, Lisa E M Hopcroft, Antony Clark, Garry Anderson, Helen Bulbeck, Joanna Dunlop, Michelle Welsh, Aimee Dyson, Julie Emerson, Carol Cochrane, Robert Hill, Jade Carruthers, Julia Day, David Gillespie, Christopher Hewitt, Emanuela Molinari, Mary Wells, Catherine McBain, Anthony J Chalmers, Robin Grant

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引用次数: 0

Abstract

Background: There are no effective treatments for brain tumor-related fatigue. We studied the feasibility of two novel lifestyle coaching interventions in fatigued brain tumor patients.

Methods: This phase I/feasibility multi-center RCT recruited patients with a clinically stable primary brain tumor and significant fatigue (mean Brief Fatigue Inventory [BFI] score ≥ 4/10). Participants were randomized in a 1-1-1 allocation ratio to: Control (usual care); Health Coaching ("HC", an eight-week program targeting lifestyle behaviors); or HC plus Activation Coaching ("HC + AC", further targeting self-efficacy). The primary outcome was feasibility of recruitment and retention. Secondary outcomes were intervention acceptability, which was evaluated via qualitative interview, and safety. Exploratory quantitative outcomes were measured at baseline (T0), post-interventions (T1, 10 weeks), and endpoint (T2, 16 weeks).

Results: n = 46 fatigued brain tumor patients (T0 BFI mean = 6.8/10) were recruited and 34 were retained to endpoint, establishing feasibility. Engagement with interventions was sustained over time. Qualitative interviews (n = 21) suggested that coaching interventions were broadly acceptable, although mediated by participant outlook and prior lifestyle. Coaching led to significant improvements in fatigue (improvement in BFI versus control at T1: HC=2.2 points [95% CI 0.6, 3.8], HC + AC = 1.8 [0.1, 3.4], Cohen's d [HC] = 1.9; improvement in FACIT-Fatigue: HC = 4.8 points [-3.7, 13.3]; HC + AC = 12 [3.5, 20.5], d [HC and AC] = 0.9). Coaching also improved depressive and mental health outcomes. Modeling suggested a potential limiting effect of higher baseline depressive symptoms.

Conclusions: Lifestyle coaching interventions are feasible to deliver to fatigued brain tumor patients. They were manageable, acceptable, and safe, with preliminary evidence of benefit on fatigue and mental health outcomes. Larger trials of efficacy are justified.

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对疲劳的脑肿瘤患者进行生活方式指导是可行的：I期/可行性、多中心、混合方法随机对照试验。

背景：对于脑肿瘤相关的疲劳，目前尚无有效的治疗方法。我们研究了两种新型生活方式指导干预措施对疲劳性脑肿瘤患者的可行性：这项 I 期/可行性多中心 RCT 研究招募了临床稳定的原发性脑肿瘤患者和明显疲劳的患者（平均简短疲劳量表 [BFI] 评分≥ 4/10）。参与者按 1-1-1 分配比例随机分配到以下项目中：对照组（常规护理）；健康指导（"HC"，针对生活方式行为的八周计划）；或健康指导加激活指导（"HC + AC"，进一步针对自我效能）。主要结果是招募和保留的可行性。次要结果是干预的可接受性（通过定性访谈进行评估）和安全性。在基线（T0）、干预后（T1，10 周）和终点（T2，16 周）测量了探索性定量结果。结果：共招募了 46 名疲劳型脑肿瘤患者（T0 BFI 平均值 = 6.8/10），其中 34 人保留至终点，从而确立了可行性。随着时间的推移，患者对干预措施的参与度持续上升。定性访谈（n = 21）表明，尽管受参与者的前景和先前生活方式的影响，但教练干预还是被广泛接受。辅导显著改善了疲劳状况（在 T1 阶段，BFI 与对照组相比有所改善：HC = 2.2 分 [95% CI 0.6, 3.8]，HC + AC = 1.8 [0.1, 3.4]，Cohen's d [HC] = 1.9；FACIT-疲劳状况有所改善：HC = 4.8 分 [-3.7, 13.3]；HC + AC = 12 [3.5, 20.5]，d [HC and AC] = 0.9）。辅导也改善了抑郁和心理健康结果。建模表明，基线抑郁症状较高可能会产生限制作用：生活方式指导干预对疲劳的脑肿瘤患者是可行的。结论：对疲劳的脑肿瘤患者进行生活方式指导干预是可行的，这些干预是可管理、可接受和安全的，有初步证据表明对疲劳和心理健康结果有益。有理由进行更大规模的疗效试验。

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