Clinical trial NCT06545188: Impact of Mortality Salience on Treatment Decisions
Official title: Impact of Mortality Salience on Treatment Decisions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Urological Cancer
Keywords: urological cancer
mortality salience
fear of death
psycho-oncology
decision making
death anxiety
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
Collaborators: name: UHN - Princess Margaret Cancer Centre, Toronto, Canada
First posted: 2024-08-09
Enrollment: 520
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study 1) Urologists: RCT; two arms - Intervention group \& control group Study 2) Patients with urological cancer: RCT; two arms - Intervention group \& control group
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Study 1) Urologists

Inclusion Criteria:

* sufficient cognitive ability
* German language skills

Exclusion Criteria:

* none

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:

* none

Primary outcomes:
measure: treatment decision
timeFrame: Day 0
Secondary outcomes:
measure: Operationalised Psychodynamic Diagnosis (OPD) structure questionnaire, OPD-SQ (Ehrenthal et al., 2015)
timeFrame: Day 0
measure: Relationships-Revised Questionnaire, ECR-RD8 (Ehrenthal et al., 2021)
timeFrame: Day 0
measure: Meaning in Life Questionnaire, MLQ (Steger et al., 2006)
timeFrame: Day 0
measure: Peace of Mind Scale, POMS (Lee et al., 2013)
timeFrame: Day 0
measure: Death Attitude Profile - Revised, DAP-GR
timeFrame: Day 0
measure: Urologists - socio-demographics
timeFrame: Day 0
measure: Urologists - job related factors
timeFrame: Day 0
measure: Urologists - Effort-Reward-Imbalance Questionnaire - short version, ERI (short version) (Siegrist et al., 2009)
timeFrame: Day 0
measure: Patients - (modified) psycho-oncological basic documentation, PO-Bado (Herschbach et al., 2004)
timeFrame: Day 0
measure: Patients - socio-demographics
timeFrame: Day 0
measure: Patients - European Health Literacy Survey 16, HLS-EU-Q16 (Röthlin et al., 2013)
timeFrame: Day 0
measure: Patients - Patient Health Questionnaire 9, PHQ-9 (Kroenke et al., 2001)
timeFrame: Day 0
measure: Patients - Generalized Anxiety Disorder 7, GAD-7 (Löwe et al., 2008)
timeFrame: Day 0
measure: Patients - Short form of the Fear of Progression Questionnaire (FoP-Q-SF) (Mehnert et al., 2006)
timeFrame: Day 0
measure: Patients - fear of cancer recurrence
timeFrame: Day 0
measure: Patients - Concerns about Recurrence Questionnaire-4, CARQ-4 (Thewes et al. 2015)
timeFrame: Day 0
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: University Hospital Düsseldorf, Department of Urology
Study officials:
affiliation: Heinrich Heine University Duesseldorf, Germany
name: Dominik Fugmann, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: