Impact of Mortality Salience on Treatment Decisions

Trial Title: Impact of Mortality Salience on Treatment Decisions

NCT ID: NCT06545188

Condition: Urological Cancer

Conditions: Official terms:
Urologic Neoplasms

Conditions: Keywords:
urological cancer
mortality salience
fear of death
psycho-oncology
decision making
death anxiety

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

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

Masking: Single (Investigator)

Intervention:

Intervention type: Other
Intervention name: Mortality Attitudes Personality Survey
Description: Two open questions about death and mortality will bei administered to trigger mortality salience
Arm group label: Mortality salience trigger

Intervention type: Other
Intervention name: Dental treatment questions (control condition)
Description: Two open questions about a dental treatment (control condition)
Arm group label: Dental pain questions (control condition)

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Start date: September 16, 2024

Completion date: October 31, 2025

Lead sponsor:
Agency: Heinrich-Heine University, Duesseldorf
Agency class: Other

Collaborator:
Agency: UHN - Princess Margaret Cancer Centre, Toronto, Canada
Agency class: Other

Source: Heinrich-Heine University, Duesseldorf

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06545188