Decisional Regret Following Radiotherapy Against Cancer With Poor to Excellent Prognosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 165
- 主要终点
- Decisional Regret
研究概览
简要总结
In this prospective registry study, patients with low-, intermediate- and high-risk tumor entities as well as patients with high symptom burden of any tumor entity in palliative constellation with indication for radiation treatment are included. This radiation treatment can be applied either as 3D-conformal RT or IGRT. The duration of treatment can range from one day to several weeks. For the primary endpoint as well as the secondary clinical and other exploratory endpoints, the 3 groups will be compared in terms of DR, QoL, toxicities and treatment plan parameters
详细描述
Decisional regret and quality of life are quantified and analyzed using general linear models (e.g. linear regression models, ANOVA), taking into account covariates such as tumor stage, application of further systemic therapies, extent of the radiation area, occurrence of acute and/or late side effects. Survival time analyses and tumor control rates are evaluated using Kaplan- Meyer and Cox regression. Technical endpoints, quality of life and patient satisfaction will be described descriptively and compared between the cohorts using a mixed linear model.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Indication for radiotherapy
- •Patient information and declaration of consent
- •Patients age ≥ 18 years
排除标准
- •previous radiotherapy in affected site or same localisation in group 1-3
- •Inability to answer the questionnaires
- •Pre-existing conditions with increased risk of acute or late toxicity (LiFraumeni, Crohn's disease, ulcerative colitis)
- •Simultaneous participation in other studies that could interfere with this study and/or participation before expiry of a required restriction period
- •Persons who are in a dependent/employment relationship with the investigator
结局指标
主要结局
Decisional Regret
时间窗: from enrollment to the end of routinely performed clinical follow-up examinations after 5 yeasr after RT start
Decisional Regret (DR) is measured by the German version of the Ottawa Decisional Regret Scale (Rühle et al. 2014) by answering the comprising 5 questions. Responses are provided on a five-point Likert scale. Decision regret is categorized as absent (0 points), mild (1-25 points) and strong (\>25 points).
Quality of Life after Radiotherapy
时间窗: from enrollment to the end of routinely performed clinical follow-up examinations after 5 yeasr after RT start
Quality of Life is measured using the 80 question comprising PRO-CTCAE questionnaire version 1.0 (Hagelstein et al 2016) , the 30 question comprising EORTC QLQC30 questionnaire version 3.0 and the PSQ-18 questionnaire (Thayaparan and Mahdi 2013). All questionnaires have been previously validated in other publications.
次要结局
未报告次要终点
研究者
Dr. med. Stephanie Bendrich
Dr. med. Stephanie Bendrich
University Medical Center Goettingen