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Existential distress in advanced cancer: Pragmatic randomized controlled trial of a short-term psychodynamic psychotherapy (ORPHYS) compared to treatment as usual (TAU)

Existential distress in advanced cancer: Pragmatic randomized controlled trial of a short-term psychodynamic psychotherapy (ORPHYS) compared to treatment as usual (TAU)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00038173
Enrollment
160
Registered
2025-10-20
Start date
2025-10-24
Completion date
Unknown
Last updated
2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced cancer

Interventions

Group 1: Experimental: ORPHYS (ShORt term psychodynamic psychotherapy adapted to serious PHYSical illness) Group 2: Active Comparator: TAU (Treatment As Usual: standard psycho-oncological care)

Sponsors

Universitätsklinikum Hamburg-Eppendorf
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - UICC stage III/IV solid tumor or advanced hematological cancer - Physical condition at beginning of treatment sufficient for outpatient treatment - Existential distress due to at least one of the following concerns: loss of hope, demoralization, fear of the future, loneliness, death anxiety, sense of isolation, death wishes - Severity of distress: significant subjective distress and impairment in functioning

Exclusion criteria

Exclusion criteria: - Acute suicidality with substantial intent to act (specific ideas and plans about ending one’s life) - ICD10 F1 or F2 diagnosis (exception: tobacco-related disorders) - Other condition that interferes with weekly outpatient setting - Current receipt of regular psycho-oncological or psychotherapeutic treatment sessions - Insufficient German to give informed consent and complete self-report questionnaires

Design outcomes

Primary

MeasureTime frame
Demoralization assessed via the Demoralization Scale-II (DS-II; Robinson et al., 2016; Koranyi et al., 2021); Time frame: pre-treatment, after 3, 6, 9, and 12 months

Secondary

MeasureTime frame
a) Diagnosis of affective disorders, anxiety disorders, trauma- and stressor-related disorders assessed via Diagnostic and Statistical Manual of Mental Disorders-5 (SCID-5; Beesdo-Baum, 2019) and CIDI Adjustment Disorder Module (Perkonigg et al., 2019); Time frame: pre-treatment, after 6 and 12 months b) Death anxiety assessed via Death and Dying Distress Scale (DADDS; Lo et al., 2011); Time frame: pre-treatment, after 3, 6, 9, and 12 months c) Dignity-related distress assessed via the Sense of Dignity Item (SDI; Chochinov et al., 2002) and the Patient Dignity Inventory (PDI; Chochinov et al., 2008; subscales "Physical Symptom Distress" and "Body Image and Loss of Autonomy"); Time frame: pre-treatment, after 3, 6, 9, and 12 months; d) Quality of life assessed via the Quality of Life at the End of Life-Cancer-Psychosocial Questionnaire (QUAL-EC-P; Grünke et al.; subscales "Life completion" and "Preparation for the end of life"); Time frame: pre-treatment, after 3, 6, 9, and 12 months

Countries

Germany

Contacts

Public ContactRebecca Philipp

Universitätsklinikum Hamburg-Eppendorf

r.philipp@uke.de+4940741056203

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: May 8, 2026