Impact of Mortality Salience on Treatment Decisions
NCT Number: NCT06545188
Acronym: MOST-D
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Urological Cancer
Interventions: OTHER: Mortality Attitudes Personality Survey|OTHER: Dental treatment questions (control condition)
Sponsor: Heinrich-Heine University, Duesseldorf
Collaborators: UHN - Princess Margaret Cancer Centre, Toronto, Canada
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 520
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-06
Completion Date: 2025-10-31

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.

Primary Outcome Measures: 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., Day 0
Secondary Outcome Measures: 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), 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), 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), 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), 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, 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), Day 0|Urologists - job related factors, professional experience (years), position (chief physician, senior physician, specialist, assistant physician), place of work (hospital, practice, both, other), 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, 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), 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: \[free text\]), 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)., 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., 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., 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., Day 0|Patients - fear of cancer recurrence, Fear of cancer recurrence, FCR-1 (Rudy et al., 2020)

1 item, scale from 0 (no fear of recuurence) to 100 (high fear of recurrence), Day 0