A Structured Early Palliative Care Intervention for Patients With Advanced Cancer - a Randomized Controlled Trial With a Nested Qualitative Study (SENS Trial)
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 6
- 主要终点
- Distress over six month as measured with the National Comprehensive Cancer Network (NCCN) Distress thermometer
研究概览
简要总结
It is assumed that an early palliative care structured by SENS (a systematic, problem-based assessment system) in addition to standard oncology care compared with standard oncology care alone relieves distress in patients with advanced cancer at the end of life.
The primary objective of the trial is to determine the effectiveness of early palliative care intervention, structured by SENS (a systematic, problem-based assessment system) in addition to standard oncology care, compared with standard oncology care alone to relieve distress a) in patients with advanced cancer until death, and b) in caregivers. The secondary objectives are to determine whether the introduction of SENS improves quality of life, prolongs overall survival, ameliorates distress of caregivers, reduces health care costs and medical resource utilization (less aggressive treatment in the last weeks of life).
详细描述
Background
Intervention (performed by specialist palliative care teams): The structured approach intervention is based on NCCN Practice Guidelines for Palliative Care, part of Gold Standard Framework (GSF) and the WHO definition of Palliative Care. It supports the assessment of areas and complexity of concerns from the patient perspective, determining priorities and structures the support needed. SENS stands for: Symptom-management, instruction for self administration of medication etc. End of life decision-making: explicit definition of own goals and priorities; Network organization including anticipatory planning of emergency situations
Support of the carers: implementation of support systems for the caring family members
The standardized intervention (based on prepared educational tool kit including a patient prompt sheet) is performed by a palliative care physician and nurse collaboratively after randomization and consent. The intervention is undertaken only once (after baseline questionnaire and before first follow-up questionnaire). There is a total of 4 questionnaires in the first 6 months. In addition, patients will receive usual oncology care throughout the study period (see below).
Usual Oncology care (performed by oncological out- and inpatient clinics): Usual care incorporates a routine assessment according to national protocols, which assesses overall symptoms and current complaints from other domains. Participants assigned to usual care may meet with the palliative care service on request according to established practice but without following the SENS approach (subgroup analysis will be performed).
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 (Investigator)
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
- •Diagnosed within the last 16 weeks
- •Metastatic or locally advanced, not amenable to curative treatment, non- small cell lung cancer (NSCLC), or
- •Metastatic or locally advanced, not amenable to curative treatment, colorectal cancer, or
- •Metastatic or locally advanced, not amenable to curative treatment, prostate cancer, or
- •Metastatic or locally advanced, not amenable to curative treatment, breast cancer with visceral and/or brain metastasis, or
- •Metastatic or locally advanced, not amenable to curative treatment, bladder/ urothelium cancer, or
- •Metastatic or locally advanced, not amenable to curative treatment, pancreatic cancer
- •Diagnosis is histologically confirmed
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2
- •At least 18 years of age at the time of enrolment
- •Signed informed consent with understanding of the study procedures and the investigational nature of the study
- •Exclusion Criteria
- •Presence of delirium or dementia or other reason for lack of ability to give informed consent
- •Inability to communicate adequately in German
- •Patient's lack of accountability, inability to appreciate the nature, meaning and consequences of the study and to formulate his/her own wishes correspondingly
- •Patients already receiving care from an inpatient palliative care service
排除标准
- 未提供
研究组 & 干预措施
Experimental arm
The structured approach intervention with the SENS model is based on the bio-psycho-social-spiritual model of care and the WHO definitions of palliative care as well as the NCCN Practice Guidelines for Palliative Care. It supports the assessment of areas and complexity of concerns from the patient perspective, determines the priority and structures the support needed. The intervention is performed by palliative care physicians and nurses collaboratively. It is utilized as baseline assessment and afterwards integrated in each routine oncology care out-patient and in-patient visit. Depending on the goals it may be applied between routine visits. In addition, patients will receive usual oncology care throughout the study period.
干预措施: SENS model (Behavioral)
Control arm
Patients in the usual care group will receive routine oncology care throughout the study. This incorporates a routine assessment according to the standard SAKK - protocol which assesses overall symptoms. Patients are not seen by nurses during a routine visit to the outpatient clinic unless they need a blood withdrawal or any intravenous or subcutaneous treatment. Only nursing staff of the palliative care unit is familiar with using the SENS-assessment instrument. Participants assigned to usual care may meet with the palliative care service on request according to established practice.
结局指标
主要结局
Distress over six month as measured with the National Comprehensive Cancer Network (NCCN) Distress thermometer
时间窗: Six months
次要结局
- Overall survival(four years)
- Health care utilization(Six months)
- Quality of life as measured by Functional Assessment of Cancer Therapy - General (FACT-G)(Six months)
- Palliative Outcome Scale (POS)(Six months)
- Location of death(Six months)