Fernandez-Rodriguez Eduardo Jose, Rihuete-Galve Maria Isabel, Garcia-Martin Alberto, Sanchez-Gomez Celia, Barbero-Iglesias Fausto Jose, Mendez-Sanchez Roberto, Puente-Gonzalez Ana Silvia, Saez-Gutierrez Susana, Fonseca-Sanchez Emilio, Cruz-Hernandez Juan Jesus
Department of Nursing and Physiotherapy, University of Salamanca, Salamanca, Spain.
Institute of Biomedical Research of Salamanca (IBSAL), Salamanca, Spain.
PLoS One. 2025 Jan 9;20(1):e0313207. doi: 10.1371/journal.pone.0313207. eCollection 2025.
In recent years, cancer survival rates have increased exponentially. However, this rise in survival comes with a significant drawback. As the number of treatment lines has grown, so too have the side effects, which can severely impact patients' functionality and quality of life. One of the most concerning effects is dyspnoea, a serious health issue that imposes substantial limitations on individuals. While traditional clinical approaches, primarily focused on pharmacological interventions, are commonly employed to manage dyspnoea, we argue that these methods may not always provide optimal symptomatic relief. Therefore, we propose a study protocol to implement an interdisciplinary intervention for these patients. This protocol aims to enhance standard clinical practice by introducing a program of functional re-education and environmental adaptation. We believe this intervention is essential for the follow-up care of patients with respiratory conditions after hospital discharge.
A two-arm, randomized, parallel, controlled clinical trial will be conducted by the University of Salamanca, Spain, in collaboration with the Medical Oncology Service of the University Health Care Complex of Salamanca. The trial aims to recruit 80 oncology patients who exhibit symptoms of dyspnoea during hospital admission. Participants will be randomly assigned to one of two groups: the control group, which will receive a health education program, and the experimental group, which will receive both the health education program and a functional re-education and environmental adaptation program. Assessments will be conducted at three time points: baseline (prior to hospital discharge), follow-up (15 days after discharge), and the end of the intervention (1 month after discharge). During these assessments, sociodemographic data will be collected, and the following scales will be administered: Barthel Index, Medical Research Council Dyspnoea Scale (mMRC), EuroQol 5-D questionnaire (EQ-5D), Visual Analogue Scale (VAS), Short Physical Performance Battery (SPPB), Tampa Scale for Kinesiophobia (TSK), and the Zarit Reduced Caregiver Burden Scale.
The findings of this research can be easily implemented in clinical settings by introducing a targeted intervention to improve the quality of life for this patient population. This study aims to advance traditional clinical approaches by facilitating the recovery or adaptation of cancer patients in their daily routines, in relation to the severity of their symptoms. Our primary goal is to enhance independence and functionality, ultimately improving their overall standard of living.
ClinicalTrials.gov; ID: NCT06035263. Registered on: September 19, 2023. https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S000DM2U&selectaction=Edit&uid=U0004OJ7&ts=6&cx=f7qqxo.
近年来，癌症生存率呈指数级增长。然而，生存率的提高伴随着一个重大缺陷。随着治疗疗程数量的增加，副作用也随之增加，这可能会严重影响患者的功能和生活质量。最令人担忧的影响之一是呼吸困难，这是一个严重的健康问题，会给个人带来极大限制。虽然传统的临床方法主要侧重于药物干预，通常用于管理呼吸困难，但我们认为这些方法可能并不总能提供最佳的症状缓解。因此，我们提出一项研究方案，为这些患者实施跨学科干预。该方案旨在通过引入功能再教育和环境适应计划来加强标准临床实践。我们认为这种干预对于出院后患有呼吸系统疾病的患者的后续护理至关重要。
西班牙萨拉曼卡大学将与萨拉曼卡大学医疗保健综合中心的医学肿瘤服务部门合作进行一项双臂、随机、平行、对照临床试验。该试验旨在招募80名在住院期间出现呼吸困难症状的肿瘤患者。参与者将被随机分配到两个组中的一组：对照组，将接受健康教育计划；实验组，将接受健康教育计划以及功能再教育和环境适应计划。将在三个时间点进行评估：基线（出院前）、随访（出院后15天）和干预结束（出院后1个月）。在这些评估期间，将收集社会人口统计学数据，并使用以下量表：巴氏指数、医学研究委员会呼吸困难量表（mMRC）、欧洲五维健康量表（EQ-5D）、视觉模拟量表（VAS）、简短体能测试电池（SPPB）、坦帕运动恐惧量表（TSK）和扎里特减轻照顾者负担量表。
通过引入有针对性的干预措施来改善这一患者群体的生活质量，本研究结果可轻松应用于临床环境。本研究旨在通过促进癌症患者根据其症状严重程度在日常生活中的恢复或适应来推进传统临床方法。我们的主要目标是提高独立性和功能，最终改善他们的整体生活水平。
ClinicalTrials.gov；标识符：NCT06035263。注册日期：2023年9月19日。https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S000DM2U&selectaction=Edit&uid=U0004OJ7&ts=6&cx=f7qqxo。
