Drijver A Josephine, Reijneveld Jaap C, Wesselman Linda M P, Klein Martin
Department of Neurology, Amsterdam UMC, Amsterdam, Netherlands.
Vrije Universiteit Amsterdam, Amsterdam, Netherlands.
JMIR Res Protoc. 2021 Apr 26;10(4):e22670. doi: 10.2196/22670.
A high percentage of patients with cancer experience cognitive impairment after cancer treatment, resulting in a decreased health-related quality of life and difficulty returning to work. Consequently, there is a need for effective treatment options to improve cognitive functioning in these patients. In a healthy aging population, multidomain web-based lifestyle interventions have been found to be effective in preventing cognitive decline and improving cognitive functioning.
This study aims to investigate the feasibility and effectiveness of the web-based lifestyle intervention Mijn Fitte Brein (My Fit Brain [MFB]) on cognitive functioning in patients with cancer returning to work.
The study consists of a feasibility study (N=10), followed by a randomized controlled trial (RCT; N=220). Patients will be recruited by their occupational physicians after their return to work following cancer treatment. Mijn Fitte Brein is organized into 4-week cycles in which patients set a lifestyle goal using the Goal Attainment Scale, receive weekly tips and support, and finally evaluate whether they succeeded in achieving this goal. Lifestyle goals are based on 6 domains: physical exercise, diet, sleep, stress, alcohol use, and smoking. In the feasibility study, data on user experience (structured interview) and usability, assessed with the Post-Study System Usability Scale, will be collected and used to optimize Mijn Fitte Brein. In the RCT, patients will be randomized 1:1 between an intervention group and a control group. Patients will be assessed at baseline, 3 months, and 6 months. The primary outcome measure is subjective cognitive functioning, assessed with the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog). Secondary outcome measures are lifestyle, objective cognitive functioning, and work and psychosocial factors.
Recruitment for the feasibility study has started in February 2020. As of July 2020, however, no patients have been enrolled (due to COVID-19 restrictions). The findings of the feasibility study will be used to optimize the Mijn Fitte Brein intervention. Enrollment for the RCT will continue when possible. The feasibility study will take 6 months (including making adjustments to the intervention), and the RCT will take 2 years. The final results are expected in 2024. The results of the feasibility study and the RCT will be published in peer-reviewed journals.
This is the first time the feasibility and efficacy of a multidomain web-based lifestyle intervention will be studied in patients with cancer. If Mijn Fitte Brein is found to be effective in decreasing cognitive complaints in these patients returning to work, it will be a promising treatment option because of being both affordable and accessible.
Netherlands Trial Register NL8407; https://www.trialregister.nl/trial/8407.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/22670.
很大比例的癌症患者在接受癌症治疗后会出现认知障碍，导致健康相关生活质量下降以及重返工作岗位困难。因此，需要有效的治疗方案来改善这些患者的认知功能。在健康的老年人群中，基于网络的多领域生活方式干预已被证明在预防认知衰退和改善认知功能方面有效。
本研究旨在调查基于网络的生活方式干预“我的健康大脑（My Fit Brain [MFB]）”对癌症康复后重返工作岗位患者认知功能的可行性和有效性。
该研究包括一项可行性研究（N = 10），随后是一项随机对照试验（RCT；N = 220）。患者在癌症治疗后重返工作岗位时由其职业医生招募。“我的健康大脑”分为4周周期，患者使用目标达成量表设定生活方式目标，每周接收提示和支持，最后评估他们是否成功实现该目标。生活方式目标基于6个领域：体育锻炼、饮食、睡眠、压力、饮酒和吸烟。在可行性研究中，将收集关于用户体验（结构化访谈）和可用性的数据，并用研究后系统可用性量表进行评估，以优化“我的健康大脑”。在RCT中，患者将以1:1的比例随机分为干预组和对照组。患者将在基线、3个月和6个月时进行评估。主要结局指标是主观认知功能，用癌症治疗功能评估-认知功能（FACT-Cog）进行评估。次要结局指标是生活方式、客观认知功能以及工作和心理社会因素。
可行性研究于2020年2月开始招募。然而，截至2020年7月，尚未招募到患者（由于COVID-19限制）。可行性研究的结果将用于优化“我的健康大脑”干预措施。RCT的招募将在可能的情况下继续进行。可行性研究将耗时6个月（包括对干预措施进行调整），RCT将耗时2年。预计最终结果将在2024年得出。可行性研究和RCT的结果将发表在同行评审期刊上。
这是首次在癌症患者中研究基于网络的多领域生活方式干预的可行性和有效性。如果发现“我的健康大脑”对这些重返工作岗位的患者减少认知主诉有效，由于其经济实惠且易于获得，它将是一个有前景的治疗选择。
荷兰试验注册NL8407；https://www.trialregister.nl/trial/8407。
国际注册报告识别码（IRRID）：DERR1-10.2196/22670。
