PSYCHO-EDUCATIONAL AND REHABILITATIVE INTERVENTION FOR THE ONCOLOGICAL PATIENT WITH CACHEXIA AND HIS CAREGIVER: A FEASIBILITY STUDY
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Feasibility of the intervention
研究概览
简要总结
Half of all cancer patients experience cachexia, with the prevalence rising above 80% in the last weeks of life. The cancer cachexia is a complex relational experience which involves the dyads patients-families. There are no studies on psychosocial interventions on dyads associated with rehabilitative interventions, to support more functional relationships to the management of cancer cachexia.
Primary objective: to evaluate the feasibility of a psycho-educational intervention combined with a physiotherapy intervention on the dyads. Secondary objective: improvement of the Quality of Life of dyads, acceptability of the intervention, adherence to each of the two components.
Methods: non-pharmacological interventional perspective, mixed-method study, addressed to a consecutive 30 cancer patients with cachexia and irreversible cachexia and their caregivers assisted by Hospital Palliative Care Unit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Age of 18 years or older
- •Good command of the Italian language
- •Written informed consent
- •Histologically confirmed tumor diagnosis
- •Presence of irreversible cachexia and cachexia (ESPEN3-5 guidelines, MUST calculation)
- •Patients who have identified a caregiver
- •Patients and family members are informed of the diagnosis and the objectives of the therapies and who have reported awareness of the disease phase (evaluated by the palliative doctor).
排除标准
- •Patients with prognosis less than three months to enable the rehabilitative intervention
- •Presence of important mental disorder or dementia
- •Severe sensory deficit
- •Presence of diffuse bone metastases that put the patient at risk of fracture during rehabilitation exercise.
结局指标
主要结局
Feasibility of the intervention
时间窗: After 2 months
The proportion of number of dyads who completed the intervention / involved dyads will be evaluated. Compliance will be assessed for each individual component (psycho-social and rehabilitative intervention). The overall intervention will be evaluated feasible if there is compliance greater than or equal to 50 percent to both interventions.
次要结局
- Hand-Grip Strenght Test(After 2 months)
- 30 seconds sit-to stand test(After 2 months)
- Ad hoc semi-structured interviews with nurses and physiotherapists(After 2 months)
- Functional Assessment of Anorexia-Cachexia Therapy (FAACT)(After 1 months)
- Zarit Burden Interview (ZBI)(After 1 months)
- Ad-hoc semi-structured interviews aimed at the dyad(After 2 months)