Urological CancerMOST-DNCT06545188
Impact of Mortality Salience on Treatment Decisions
A study testing Mortality Attitudes Personality Survey in people with Urological Cancer, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urological Cancer
- What is being tested?
- Mortality Attitudes Personality Survey
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 746 participants
- Where
- 1 siteGermany
- Study dates
- 16 Sep 2024to 8 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- sufficient cognitive ability
- German language skills
- 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
Who cannot join
- none
- Study 2) Patients
- none
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Düsseldorf, Department of Urology
Düsseldorf, 40225
About this study
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?
Read more
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.
Read the 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.
- Conditions
- Urological Cancer
- Being tested
- Mortality Attitudes Personality Survey, Dental treatment questions (control condition)
- Keywords
- urological cancer, mortality salience, fear of death, psycho-oncology, decision making, death anxiety
- Medical subject headings
- Urologic Neoplasms, Necrophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mortality Attitudes Personality SurveyOther
Two open questions about death and mortality will bei administered to trigger mortality salience
Dental treatment questions (control condition)Other
Two open questions about a dental treatment (control condition)
| Study group | Role | What they receive |
|---|---|---|
| Mortality salience trigger | Experimental | Mortality Attitudes Personality Survey (MAPS, Rosenblatt et al. 1998) will be administered (two open questions about death and mortality) Receives: Other: Mortality Attitudes Personality Survey |
| Dental pain questions (control condition) | Other | Two open questions about a dental treatment will be administered Receives: Other: Dental treatment questions (control condition) |
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment decision
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.
Measured: Day 0
Secondary outcomes (16)
Operationalised Psychodynamic Diagnosis (OPD) structure questionnaire, OPD-SQ (Ehrenthal et al., 2015)
12 items, 5-point likert scale, sum score 0 (high level of structure) to 48 (low level of structure) (Ehrenthal et al., 2012)
Measured: Day 0
Relationships-Revised Questionnaire, ECR-RD8 (Ehrenthal et al., 2021)
two subscales: attachment-related avoidance (4 items) and attachment-related anxiety (4 items), 8 items total, 7-point likert scale, sum score from 0 to 48 (higher values correspond to a higher expression of the dimension)
Measured: Day 0
Meaning in Life Questionnaire, MLQ (Steger et al., 2006)
two subscales: search for meaning (5 items) and presence of meaning (5 items), 10 items total, 7-point likert scale, sum score form 5 to 35 per scale with lower levels indicating higher expression of the dimension)
Measured: Day 0
Peace of Mind Scale, POMS (Lee et al., 2013)
7 items, 5-point likert scale, sum score form 7 to 35 (higher levels indicate more peace of mind)
Measured: Day 0
Death Attitude Profile - Revised, DAP-GR
five subscales: fear of death (7 items), death avoidance (5 items), neutral acceptance (5 items), approach acceptance (10 items), escape acceptance (5 items), 35 items total, 7-point likert scale, an average value is calculated for each subscale by dividing the sum score of the domain by the number of its items
Measured: Day 0
Urologists - socio-demographics
age (years), gender (male, female, other), relationship status (yes, no), children (yes, no), underage children living in the same household (yes, no)
Measured: Day 0
Urologists - job related factors
professional experience (years), position (chief physician, senior physician, specialist, assistant physician), place of work (hospital, practice, both, other)
Measured: Day 0
Urologists - Effort-Reward-Imbalance Questionnaire - short version, ERI (short version) (Siegrist et al., 2009)
Three subscales: Effort (7 items), reward (3 items), work stress (6 items), 16 items total, 4-point-likert scale (1 to 4), sum scores for each domain with higher levels corresponding to higher expression of the dimension
Measured: Day 0
Patients - (modified) psycho-oncological basic documentation, PO-Bado (Herschbach et al., 2004)
gender (male, female, other), partnership (yes, no) children (yes, no), underage children living in the same household (yes, no), work situation (employed, on sick leave, housework, pension, unemployed, other [free text]), metastases (yes, no, unknown), date of first diagnosis (month/year, unknown), current disease status (first disease, second disease, relapse, remission, unknown), treatments in the last two months (surgery, radiation, chemotherapy, other systemic therapy / drug treatment for cancer (e.g. immunotherapy), hormones, none, other [free text]), other relevant physical illnesses (yes, which? Immunotherapy), hormones, none, other [free text]), other relevant physical illnesses (yes, which? [free text], no, not known), psychotropic drugs / opiates (yes, which? [free text], no, not known), psychological / psychiatric treatment in the past? (yes, no, not known)
Measured: Day 0
Patients - socio-demographics
age (years), education (no school-leaving certificate, primary school leaving certificate, secondary school leaving certificate ('Hauptschule' or 'Realschule'), Polytechnical high school 10th grade (before 1965: 8th grade), technical secondary school leaving certificate, high school diploma, I have another school-leaving certificate, namely: [free text])
Measured: Day 0
Patients - European Health Literacy Survey 16, HLS-EU-Q16 (Röthlin et al., 2013)
Four dimensions: accessing, understanding, assessing and using health information, 16 items, four response categories are binarized (1 = "very easy / "fairly easy"; 0 = "very difficult" / "fairly difficult") and added together to form a total score: "adequate" (13-16 points), "problematic" (9-12 points) and "inadequate" (1-8 points).
Measured: Day 0
Patients - Patient Health Questionnaire 9, PHQ-9 (Kroenke et al., 2001)
A total score (0 - 27 points) is calculated from nine items on a four-point Likert scale. The following grading can be used: 0 - 4 points: minimal depressive symptoms, 5 - 9 points: mild depressive symptoms, 10 - 14 points: mild depressive symptoms, 15 - 19 points: moderate depressive symptoms, 20 - 27 points: severe depressive symptoms.
Measured: Day 0
Patients - Generalized Anxiety Disorder 7, GAD-7 (Löwe et al., 2008)
A total score (0 - 21 points) is calculated from seven items, each with a four-point Likert scale. The threshold value for increased anxiety is 10 points.
Measured: Day 0
Patients - Short form of the Fear of Progression Questionnaire (FoP-Q-SF) (Mehnert et al., 2006)
The questionnaire comprises 12 items with a five-point Likert scale, from which a total score of 12 to 60 points can be calculated. Moderate progressive anxiety is present if more than 50 % of the questions are answered with "often" or "very often", high progressive anxiety with more than 75 % of the questions.
Measured: Day 0
Patients - fear of cancer recurrence
Fear of cancer recurrence, FCR-1r (Smith et al., 2023)
1 item, scale from 0 (no fear of recuurence) to 10 (high fear of recurrence)
Measured: Day 0
Patients - Concerns about Recurrence Questionnaire-4, CARQ-4 (Thewes et al. 2015)
The first three items are rated on an 11-point Likert scale from 0 to 10. Item 4 asks for the subjective probability of cancer recurrence (0 to 100), which is then converted to a 0-10 scale. Thus, the total score ranges from 0 to 40, with scores of 12 or higher indicating elevated fear of cancer recurrence levels.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start16 Sep 2024
- Primary completion8 Nov 2025
- Study completion8 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urological CancerStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 746 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Collaborators
- UHN - Princess Margaret Cancer Centre, Toronto, Canada
- Responsible party
- Sponsor
- Investigators
- Dominik Fugmann, Dr. med., Principal investigator, Heinrich Heine University Duesseldorf, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06545188
- Sponsor's protocol ID
- GFFU Heigl Foundation 82301
- Acronym
- MOST-D
- Status last verified
- Feb 2025
- First submitted
- 15 Jul 2024
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Mortality Salience on Treatment Decisions
- ClinicalTrials.gov ID
- NCT06545188
- Acronym / sponsor ID
- MOST-D / GFFU Heigl Foundation 82301
- Conditions
- Urological Cancer
- Keywords
- urological cancer, mortality salience, fear of death, psycho-oncology, decision making, death anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 746 participants (actual)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Collaborators
- UHN - Princess Margaret Cancer Centre, Toronto, Canada
- Study start
- 16 Sep 2024 (actual)
- Primary completion
- 8 Nov 2025 (actual)
- Study completion
- 8 Nov 2025 (actual)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Mortality salience trigger | Experimental | Other: Mortality Attitudes Personality SurveyMortality Attitudes Personality Survey (MAPS, Rosenblatt et al. 1998) will be administered (two open questions about death and mortality) |
| Dental pain questions (control condition) | Other | Other: Dental treatment questions (control condition)Two open questions about a dental treatment will be administered |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- sufficient cognitive ability
- German language skills
- urological cancer (ICD-10: C60, C61, C62, C63, C64, C65, C66, C67, C68)
- age at least 18 years
- German language skills
Key exclusion criteria (3 listed)
- none
- Study 2) Patients
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mortality Attitudes Personality SurveyTwo open questions about death and mortality will bei administered to trigger mortality salience | Other | Mortality salience trigger |
| Dental treatment questions (control condition)Two open questions about a dental treatment (control condition) | Other | Dental pain questions (control condition) |
Primary outcome
treatment decision
Time frame: 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.
16 secondary outcomes
Operationalised Psychodynamic Diagnosis (OPD) structure questionnaire, OPD-SQ (Ehrenthal et al., 2015)
Time frame: Day 0
Relationships-Revised Questionnaire, ECR-RD8 (Ehrenthal et al., 2021)
Time frame: Day 0
Meaning in Life Questionnaire, MLQ (Steger et al., 2006)
Time frame: Day 0
Peace of Mind Scale, POMS (Lee et al., 2013)
Time frame: Day 0
Death Attitude Profile - Revised, DAP-GR
Time frame: Day 0
Urologists - socio-demographics
Time frame: Day 0
Urologists - job related factors
Time frame: Day 0
Urologists - Effort-Reward-Imbalance Questionnaire - short version, ERI (short version) (Siegrist et al., 2009)
Time frame: Day 0
Patients - (modified) psycho-oncological basic documentation, PO-Bado (Herschbach et al., 2004)
Time frame: Day 0
Patients - socio-demographics
Time frame: Day 0
Patients - European Health Literacy Survey 16, HLS-EU-Q16 (Röthlin et al., 2013)
Time frame: Day 0
Patients - Patient Health Questionnaire 9, PHQ-9 (Kroenke et al., 2001)
Time frame: Day 0
Patients - Generalized Anxiety Disorder 7, GAD-7 (Löwe et al., 2008)
Time frame: Day 0
Patients - Short form of the Fear of Progression Questionnaire (FoP-Q-SF) (Mehnert et al., 2006)
Time frame: Day 0
Patients - fear of cancer recurrence
Time frame: Day 0
Patients - Concerns about Recurrence Questionnaire-4, CARQ-4 (Thewes et al. 2015)
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominik Fugmann, Dr. med. principal investigator
Heinrich Heine University Duesseldorf, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mortality Attitudes Personality Survey in people with Urological Cancer, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
treatment decision (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.