Impact of Mortality Salience on Treatment Decisions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 746
- 试验地点
- 1
- 主要终点
- treatment decision
研究概览
简要总结
The goal of this clinical trial is to learn if mortality salience has an impact on treatment decisions in urologists and patients with urological cancer. The main questions it aims to answer are:
Does mortality salience lead to more aggressive treatment decisions in a) urologists and b) patients with urological cancer? Which factors predict more aggressive treatment decisions a) in urologists and b) in patients with urological cancer? Is the Fear of cancer recurrence-1 (FCR-1) in German language a valid screening tool for fear of cancer progression in patients with urological cancer?
Researchers will compare a mortality salience trigger to control questions to see if mortality salience leads to more aggressive treatment decisions.
Participants will:
Answer the Mortality Attitudes Personality survey (MAPS) to trigger mortality salience and, in three borderline case vignettes, provide information on how likely they would be to choose a more aggressive therapy.
详细描述
Background: Harmful overtreatment is a major problem in oncology. Unconscious fear of death (mortality salience) could increase the likelihood of a physician or patient decision in favor of aggressive therapy and thus contribute to overtreatment.
Methods: Conduction of two randomized controlled trials: 1. online survey of n = 260 urological patients, 2. paper questionnaire survey of n = 260 urological cancer inpatients. Intervention group: triggering of mortality salience with two open questions on death, control group: two open questions on dental treatment. The primary endpoint is the probability of opting for aggressive treatment in three questions on a treatment decision Likert scale from 0 to 10). In both studies, the evaluation is carried out as a comparison of means using a two-sided t-test. Secondary endpoints are further factors associated with a decision in favor of aggressive therapy.
Result: An increase in the probability of a decision in favor of the more aggressive therapy as a result of triggering mortality salience is expected with an effect size of d = .35.
Discussion: In order to avoid harmful overtreatment due to unconscious fear of death, doctors could undergo training to deal with their existential fears - this could take place as part of communication training. For cancer patients, this confrontation can take place as part of psycho-oncology training.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Study 1) Urologists
- •Inclusion Criteria:
- •sufficient cognitive ability
- •German language skills
排除标准
- •Study 2) Patients
- •Inclusion Criteria:
- •urological cancer (ICD-10: C60, C61, C62, C63, C64, C65, C66, C67, C68)
- •age at least 18 years
- •German language skills
- •sufficient cognitive ability
- •capacity to consent
- •Exclusion Criteria:
研究组 & 干预措施
Mortality salience trigger
Mortality Attitudes Personality Survey (MAPS, Rosenblatt et al. 1998) will be administered (two open questions about death and mortality)
干预措施: Mortality Attitudes Personality Survey (Other)
Dental pain questions (control condition)
Two open questions about a dental treatment will be administered
干预措施: Dental treatment questions (control condition) (Other)
结局指标
主要结局
treatment decision
时间窗: Day 0
Question about how likely the subject would opt for the more aggressive of two possible therapies on a Likert scale from 0 = very unlikely to 10 = very likely.
次要结局
- Operationalised Psychodynamic Diagnosis (OPD) structure questionnaire, OPD-SQ (Ehrenthal et al., 2015)(Day 0)
- Relationships-Revised Questionnaire, ECR-RD8 (Ehrenthal et al., 2021)(Day 0)
- Meaning in Life Questionnaire, MLQ (Steger et al., 2006)(Day 0)
- Peace of Mind Scale, POMS (Lee et al., 2013)(Day 0)
- Death Attitude Profile - Revised, DAP-GR(Day 0)
- Urologists - socio-demographics(Day 0)
- Urologists - job related factors(Day 0)
- Urologists - Effort-Reward-Imbalance Questionnaire - short version, ERI (short version) (Siegrist et al., 2009)(Day 0)
- Patients - (modified) psycho-oncological basic documentation, PO-Bado (Herschbach et al., 2004)(Day 0)
- Patients - socio-demographics(Day 0)
- Patients - European Health Literacy Survey 16, HLS-EU-Q16 (Röthlin et al., 2013)(Day 0)
- Patients - Patient Health Questionnaire 9, PHQ-9 (Kroenke et al., 2001)(Day 0)
- Patients - Generalized Anxiety Disorder 7, GAD-7 (Löwe et al., 2008)(Day 0)
- Patients - Short form of the Fear of Progression Questionnaire (FoP-Q-SF) (Mehnert et al., 2006)(Day 0)
- Patients - fear of cancer recurrence(Day 0)
- Patients - Concerns about Recurrence Questionnaire-4, CARQ-4 (Thewes et al. 2015)(Day 0)