Heart Pillow - Chemoteraphy
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Recovering mobility in the homolateral upper limb
研究概览
简要总结
Breast cancer is a health problem with increasing prevalence, along with more effective therapeutic responses and less mutilating surgeries. The process of caring for patients crosses different levels: the diagnostic phase, which is mostly outpatient, the surgical treatment phase, which is mostly short-term inpatient, and the medical treatment phase in a day hospital. An integrated and structured care model based on specialized nursing skills can help improve self-care, quality of life and well-being.
详细描述
Detailed description 1:
The intervention project is developed during the medical treatment phase and is designed to reconcile multidisciplinary interventions and accompany patients during this phase. Self-care is the central concept of the project, it is multidimensional but the approach in the project is centered on a disease process and people-centered healthcare responses. It is estimated that the early initiation of activities that promote the recovery of self-care and the reduction of complications resulting from immobility of the homolateral upper limb or the formation of scar adhesions may reduce the time and costs dedicated to rehabilitation care at a later stage.
The study includes personalized interventions, carried out with patients every three weeks, from the beginning until discharge from chemotherapy treatment. Once informed consent has been obtained, the first session carried out by the rehabilitation nurse includes the patient's assessment, the allocation of the Heart pillow with a teaching session and training for its use. The first assessment includes: sociodemographic and health characterization, assessment of symptoms and quality of life (EORTC QLQ-C3 version 3.0 and EORTC QLQ-Br23), independence in ADL (Barthel Scale), upper limb functionality (DASH Portuguese version), sleep quality (PSQI-PT), assessment of grip strength by dynamometry (Dynamometry), assessment of the range of movement of the upper limbs by goniometry and assessment of the presence of edema by measuring the limb circumference. The data collected at this stage are analyzed from a clinical perspective to define the individual care plan: Intervention in self-care and the symptoms mentioned.
Every 3 weeks, the assessment of symptoms, independence of daily activities, strength, range of movement and lymphedema are repeated, providing data on progress but also for assessing the individual care plan from which teaching and training interventions are carried out, appropriate for each participant.
The final assessment coincides with the completion of the last chemotherapy treatment session, the assessments of the intermediate phase are repeated and independence in instrumental activities and sleep quality are assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Breast cancer patients undergoing chemotherapy after surgery.
排除标准
- •Patients with breast cancer who did not undergo surgical treatment.
结局指标
主要结局
Recovering mobility in the homolateral upper limb
时间窗: Every 3 weeks until the end of chemotherapy treatment. The result of the evaluation is translated into: Kgf (Muscle strength); Degrees (goniometry). Time Points: T0-first evaluation appointment (chemotherapy); T1 at Tx-evaluation every 3 weeks
The measures used are functional assessment of the upper limb with the Disabilities of the Arm, Shoulder and Hand (DASH-PT) scale: 30-item self-reported questionnaire in which the response options are presented as 5-point Likert scales. Scores range from 0 (no disability) to 100 (most severe disability). Assessment of muscle strength with dynamometry and assessment of amplitude by goniometry.
次要结局
未报告次要终点
研究者
José Manuel Afonso Moreira
Clinical Professor
University of Évora