Individualized Prognostic Counseling on Life Expectancy of Head and Neck Cancer Patients in the Palliative Phase
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Decisional conflict
研究概览
简要总结
The investigators test the effect of providing individualized prognostic information on life-expectancy to head and neck cancer patients in the palliative phase.
详细描述
In this prospective sequential cohort study, the investigators aim to include 160 patients with a palliative diagnosis of head and neck squamous cell carcinoma, divided into two cohorts. In cohort 1, patients will receive general prognostic counselling, while in cohort 2, patients will receive individualized prognostic counselling using the recently developed prognostic model 'OncologIQ Palliative'. Cohort 2 will commence after completion of cohort 1. The primary outcome will be decisional conflict and satisfaction with the decision-making process and proactive care planning. Additionally, we will assess whether patients undergo palliative treatment and, if so, the type of treatment received. We will also evaluate overall survival, the incidence of palliative sedation or euthanasia, and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 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
- •Patients who received a palliative diagnosis of a squamous cell carcinoma of the oral cavity, oropharynx, nasopharynx, hypopharynx, supraglottic larynx, glottis larynx and unknown primary.
排除标准
- •Illiterate patients
- •Insufficient knowledge of Dutch language
- •Incompetent (due to i.e. mental state) to consider their own treatment choice
研究组 & 干预措施
Cohort 1
Current general counselling on life expectancy
Cohort 2
Individualized prognostic counselling on life expectancy
干预措施: Individualized prognostic counselling (Other)
结局指标
主要结局
Decisional conflict
时间窗: 2 weeks
Decisional conflict (DC) will be assessed using the Decisional Conflict Scale (DCS) questionnaire, reported two weeks after the consultation in which the palliative diagnosis is shared. The overall score can range from 0 (no DC) to 100 (extremely high DC). A score of ≥25 is considered the cutoff for clinically significant decisional conflict.
Satisfaction with decision making process and proactive care planning
时间窗: 3-4 weeks
To measure satisfaction with decision making process and proactive care planning, including end-of-life discussions on preferred place of death and wishes for palliative sedation and euthanasia we will conduct interviews among patients after counselling with OncologIQ Palliative
次要结局
- Treatment(At the end of the study)
- Survival(Through study completion, up to 2 years)
- Quality of Life Score(Baseline and every 6-8 weeks)
- Palliative sedation and Euthanasia(Through study completion, up to 2 years)
研究者
Dr. Marinella P. J. Offerman
Associate Professor
Erasmus Medical Center