Effects of Nurse-led Telephone Based Service for Early Palliative Care Patients With Advanced Cancer: the Paltel Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Edmonton Symptoms Assessments System (ESAS)
研究概览
简要总结
Non-pharmacological, interventional, two-arm, randomized controlled trial. Early Palliative Care cancer patients will be randomized to active telephonic follow-up program by specialist nurses until end-of-treatment (28 days) (group A, research arm) or face-to-face visit at end of treatment (28 days) (group B, control arm).
There are few studies demonstrating the efficacy of nurse-led telephone service in advanced cancer patients but it's still quite unclear how they can affect quality of life, symptom burden and caregivers distress. In addition, the ideal structure, method and timing of telephone follow-up as well are often not considered and have not been articulated. Nurse-led management by phone to advanced cancer patients could, for some patients, dramatically improve their care experience, quality of life and symptoms control.
Investigators want to build an effective and sustainable approach for implementing the telephone service providing nurse-led telephone-based support to Early Palliative Care cancer patients. The aim is to investigate the feasibility of a proactive approach and measure the efficacy in terms of symptom management, satisfaction with care and impact on health care resources.
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
- 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
- •Participant is willing and able to give informed consent for participation in the study;
- •Patients having a defined Caregiver
- •Cancer patients referred for the first time to the Early Palliative Care Outpatient Clinic;
- •Both Female or Male, aged ≥ 18 years;
- •Italian speaking patients.
排除标准
- •Eastern Cooperative Oncology Group (ECOG) Performance Status score of 3 or higher
- •Patients cognitively impaired or deaf;
- •Patients not having a telephone or not capable of speaking/using a telephone;
- •Patients referred to palliative Homecare or Hospice at the first visit Early Palliative Care Outpatient Clinic.
结局指标
主要结局
Edmonton Symptoms Assessments System (ESAS)
时间窗: 3 years
ESAS is a questionnaire to rate common symptoms experienced by cancer patients, including pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being and shortness of breath. The severity at the time of assessment of each symptom is rated from 0 to 10 on a numerical scale, with 0 meaning that the symptom is absent and 10 that it is the worst possible severity (total score 0-90).
Italian Integrated Palliative Care Outcome Scale (IPOS)
时间窗: 3 years
The IPOS is a patient-reported outcome measures, valid and reliable both in patient self-report and staff proxy-report versions to assess and monitor symptoms and concerns in advanced illness, determine the impact of healthcare interventions, and demonstrate quality of care.
次要结局
- Use of healthcare services(3 years)
- Number of hospital referrals(3 years)
- FAMCARE-2(3 years)
- Patients' access to the local Palliative care network(3 years)
- Intervention of Palliative Care Outpatient Clinic(3 years)