TeleRehabilitation: an Innovative User-centered STrategic Approach for the treatMent of Central and Peripheral Neurological sEquelae From Chemotherapy - TRUST_ME
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Changes in Activation level of Patients measured by Patient Activation Measure 13 (PAM13; Hibbard et al., 2004)
研究概览
简要总结
The goal of this clinical trial is to validate the use of innovative tele-rehabilitation (TR) models in terms of efficiency and effectiveness in a pilot cohort of subjects with central and peripheral chemotherapy-induced neurotoxicity. Participants will be randomized (with an allocation ratio of 1:1) into the experimental group (TRUST_ME - 15 sessions of motor and cognitive activities delivered at home through a TR approach using the Maia platform) and Treatment as Usual (15 sessions of multimedia content of educational/rehabilitation activities delivered via telemedicine platfom). It expected that the TR system to be considered acceptable in terms of efficiency (usability and acceptability of the technologies) and clinically effective, with positive impacts on both quality of life and central and peripheral functioning in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult subjects (>18 years old) with central and/or peripheral neurotoxic sequelae following a history of cancer treated with chemotherapeutic agents (Cisplatin and Taxanes), in accordance with the criteria of the International Cognitive Cancer Task Force (Wefel et al.,
- •10.1016/S1470-2045(10)70294-1)
- •agreement to participate with the signature of the informed consent form;
排除标准
- •Ongoing chemotherapy treatment;
- •Pre-existing neurological or psychiatric comorbidities (e.g., epilepsy, post-stroke disability, neurodegenerative diseases, genetically based polyneuropathy);
- •Severe visual or hearing impairments that could interfere with the use of technology;
- •Severe cognitive impairment (Mini-Mental State Examination score <18);
- •Severe postural disability associated with a high risk of falling at home, as documented in the clinical evaluation;
- •Contraindications to undergoing MRI examination;
- •Ongoing rehabilitation treatment.
结局指标
主要结局
Changes in Activation level of Patients measured by Patient Activation Measure 13 (PAM13; Hibbard et al., 2004)
时间窗: Time Frame: Baseline, post-treatment (up to 5 weeks)
PAM13 is a 13-item scale that assesses a person's underlying knowledge, skills and confidence integral to managing his or her health and healthcare. PAM13 total score ranging from 0 to 100. Higher values represent a better outcome. Specifically, individuals in the lowest activation level do not yet understand the importance of their role in managing their health and have significant knowledge gaps and limited self-management skills. Individuals in the highest activation level are proactive with their health, have developed strong self- management skills, and are resilient in times of stress or change.
次要结局
- Change in global cognitive functioning and subdomains measured by Montreal Cognitive Assessment (MoCA; Santangelo et al., 2015)(Baseline, post-treatment (up to 5 weeks))
- Change in Functional Assessment of Cancer Therapy-Cognitive Function - FACT-Cog (Fardell et al., 2022. 10.1002/pon.5928);(Baseline, post-treatment (up to 5 weeks))
- Change in EORTC CIPN-20 questionnaire (Postam et al., 2005).(Baseline, post-treatment (up to 5 weeks))
- Change in Patient Health Engagement Scale (PHE) (Graffigna et al., 2017)(Baseline, post-treatment (up to 5 weeks))
- Change in visuoperceptual and attentional abilities measured by Trail Making Test (TMT part-A and part-B; Giovagnoli et al., 1996)(Baseline, post-treatment (up to 5 weeks))
- Change in long term visual memory measured by Free and Cued Selective Reminding Test (FCSRT) (Frasson et al., 2011)(Baseline, post-treatment (up to 5 weeks))
- Change in Static and dynamic balance measured by Mini-Best Test (Franchignoni et al., 2010)(Baseline, post-treatment (up to 5 weeks))
- Change in Aerobic Capacity and Gait measured by 6' Minute Walking Test (6MWT)(Baseline, post-treatment (up to 5 weeks))
- Change in strength level using a dynamometer(Baseline, post-treatment (up to 5 weeks))