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临床试验/NCT06035263
NCT06035263尚未招募不适用

Effects of a Functional Re-education and Environmental Adaptation Programme on Levels of Dependency, Dyspnoea, Functional Capacity, Quality of Life and Caregiver Burden in Cancer Patients With Associated Respiratory Pathology

University of Salamanca2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
80
试验地点
2
主要终点
Activities of daily living

研究概览

简要总结

the investigators propose an interdisciplinary intervention, carried out by occupational therapists, nurses, physiotherapists and doctors specialised in this type of patient, aimed at improving conventional clinical practice and implementing a programme of functional re-education and environmental adaptation that implements conventional clinical practice, and which the investigators also consider to be an essential intervention in the follow-up of patients with associated respiratory pathology once they are discharged from hospital.

详细描述

In recent years, improvements in oncological treatments, together with a strong commitment to preventive strategies, have led to better early diagnosis and better knowledge of the oncological pathology itself, resulting in an exponential increase in the survival of cancer patients. All of this has led to the increasing importance of the concept of "long survivorship".

Along with this increase in survival and the resulting increase in the number of lines of treatment used, there has been an increase in side effects that negatively impact aspects such as functionality or quality of life in patients. Some of these effects may include tumour asthenia, anxiety or associated respiratory pathology (dyspnoea). In some patients with advanced cancer, dyspnoea may be a clinical sign of end-stage disease. Approximately 41% of palliative care patients have dyspnoea and 46% of these describe it as moderate or severe. Furthermore, this incidence increases significantly in patients with an anatomopathological diagnosis of lung cancer, reaching incidences of more than 73% in various studies.

Most patients perceive this dyspnoea as a limiting factor beyond their control, leading to avoidance behaviours that further increase their inactivity. This inevitably has a negative impact on their functionality and leads to patterns of fear/avoidance of exercise in cancer patients, as seen in patients with chronic pain, chronic fatigue syndrome or fibromyalgia. Patients with respiratory problems adapt to their symptoms by reducing their activity levels. This leads to a deterioration in physical fitness and exertional dyspnoea, known as the "respiratory patient cycle".

For the control of dyspnoea, the investigators believe that the measures used in conventional clinical practice, developed mainly from a pharmacological point of view, can be implemented, but that they are not sufficient to achieve optimal symptomatic control.

Current pharmacological treatment does not always manage to control the main symptom of respiratory pathologies: dyspnoea, perhaps because of its multifactorial nature. Most patients perceive this symptom as a limiting factor beyond their control, leading them to adopt avoidance behaviours that increase their inactivity, with negative consequences for their functionality. Therefore, from the point of view of comprehensive care for the patient, not only for the symptom, the investigators have observed that it is necessary to use other interventions that achieve the patient's readaptation to their daily activity.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

盲法说明

Subjects will also be blinded and will not know which group they have been allocated to and therefore which intervention they will receive. In order to minimise any contamination between groups, the assessment process will be carried out by external research staff who will perform the measurements and who have been previously trained and educated to avoid subjective bias in the process, as they will be unaware of the intervention group to which each elderly centre is assigned, so the clinical trial will have a masking of the blinded assessment by third parties.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • To have, among the reasons for admission, an anatomopathological diagnosis of newly diagnosed or relapsed oncological disease.
  • To be admitted to the Oncology Department of the University Hospital of Salamanca.
  • Moderate to severe dependency: Barthel Index score between 20 and 55 points.
  • Sign an informed consent form authorising their voluntary participation in the study.

排除标准

  • Cognitive impairment as assessed by the Mini-Mental State Examination (MMSE) of less than 24 points.
  • Haemoglobin level of less than 10g/dl.

结局指标

主要结局

Activities of daily living

时间窗: Baseline; 1 week (follow up); 2 weeks (final)

Barthel Index

次要结局

  • General Pain(Baseline; 1 week (follow up); 2 weeks (final))
  • Physical performance assessment(Baseline; 1 week (follow up); 2 weeks (final))
  • pain/fatigue-related fear of movement(Baseline; 1 week (follow up); 2 weeks (final))
  • dyspnoea(Baseline; 1 week (follow up); 2 weeks (final))
  • Health-related quality of life(Baseline; 1 week (follow up); 2 weeks (final))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Dr. Eduardo J Fernández Rodríguez

Professor

University of Salamanca

研究点 (2)

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