Clinical trial · Interventional
Existential Distress in Advanced Cancer: Comparing a Short-term Psychodynamic Psychotherapy (ORPHYS) 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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The psychological challenges faced by patients with incurable cancer and their caregivers include an uncertain future, fear of dying and uncontrollable suffering, grief, and loneliness. In a significant subgroup, this challenge is associated with significant fear and existential distress. This distress can manifest itself, for example, in the form of demoralization, a state of despair and hopelessness in which the possibilities for coping seem exhausted. Although open discussions about fears at the end of life are becoming increasingly important, little is known about how patients with high existential distress can best be supported to promote quality of life. The aim of the study is to test the effectiveness of the newly developed individual psychotherapy ORPHYS (ShORt-term psychodynamic psychotherapy in serious PHYSical illness) in reducing existential distress. To this end, a randomly selected half of the participants who receive ORPHYS treatment will be compared with a second group who receive the standard routine psycho-oncological treatment TAU (Treatment As Usual). The level of distress caused by demoralization will be used for the comparison. A total of 160 patients with advanced cancer will be included in the study. Due to improved treatment options, life expectancy for advanced cancer has increased significantly. This means that patients and their families must deal with the existential tension between uncertainty and a focus on life. The treatment is intended to contribute to providing the best possible support for patients who suffer from uncertainty and fears at the end of life.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer, Various, NOS | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ORPHYS (ShORt-term psychodynamic psychotherapy in serious PHYSical illness) | Behavioral | — | UNRESOLVED |
| TAU (Treatment As Usual: Standard psycho-oncological care) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ORPHYS (ShORt term psychodynamic psychotherapy adapted to serious PHYSical illness)
- interventionNames
- Behavioral: ORPHYS (ShORt-term psychodynamic psychotherapy in serious PHYSical illness)
- type
- ACTIVE_COMPARATOR
- label
- TAU (Treatment As Usual: standard psycho-oncological care)
- interventionNames
- Behavioral: TAU (Treatment As Usual: Standard psycho-oncological care)
Primary outcomes (1)
- measure
- Demoralization assessed via the Demoralization Scale-II (DS-II; Robinson et al., 2016; Koranyi et al., 2021)
- timeFrame
- Day 0, Month 3, Month 6, Month 9, Month 12
- description
- Items are scored on a 3-point Likert scale from 0 (never) to 2 (often), with a total score ranging from 0 to 32. Higher scores indicate higher demoralization.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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: * Acute suicidality with concrete or impending intent to follow through (suicide plan) * diagnosis of a substance dependence, substance abuse, or psychotic disorder (exception: tobacco-related disorders) * Inability to adhere to a psychotherapeutic setting * Other current psychotherapeutic or psycho-oncological treatment according to TAU definition * Insufficient German to give informed consent and complete self-report questionnaires
References
Publications (12)
- BACKGROUNDPhilipp R, Walbaum C, Lindner R, Karger A, Maatouk I, Dinger U, Vehling S. [ORPHYS - Treatment Manual for a Short-Term Psychodynamic Psychotherapy in Patients with Serious Physical Illness]. Psychother Psychosom Med Psychol. 2024 Aug;74(8):345-351. doi: 10.1055/a-2322-8596. Epub 2024 Jun 17. German. PMID 38885656
- BACKGROUNDPerkonigg A, Strehle J, Beesdo-Baum K, Lorenz L, Hoyer J, Venz J, Maercker A. Reliability and Validity of a German Standardized Diagnostic Interview Module for ICD-11 Adjustment Disorder. J Trauma Stress. 2021 Apr;34(2):275-286. doi: 10.1002/jts.22597. Epub 2020 Nov 5. PMID 33151596
- BACKGROUNDHuber J, Nikendei C, Ehrenthal JC, Schauenburg H, Mander J, Dinger U. Therapeutic Agency Inventory: Development and psychometric validation of a patient self-report. Psychother Res. 2019 Oct;29(7):919-934. doi: 10.1080/10503307.2018.1447707. Epub 2018 Mar 20. PMID 29557306
- BACKGROUNDBrahler E, Horowitz LM, Kordy H, Schumacher J, Strauss B. [Validation of the Inventory for Interpersonal Problems (IIP). Results of a representative study in East and West Germany]. Psychother Psychosom Med Psychol. 1999 Nov;49(11):422-31. German. PMID 10593141
- BACKGROUNDGalushko M, Strupp J, Walisko-Waniek J, Hahn M, Loffert S, Ernstmann N, Pfaff H, Radbruch L, Nauck F, Ostgathe C, Voltz R. Validation of the German version of the Schedule of Attitudes Toward Hastened Death (SAHD-D) with patients in palliative care. Palliat Support Care. 2015 Jun;13(3):713-23. doi: 10.1017/S1478951514000492. Epub 2014 May 22. PMID 24849188
- BACKGROUNDEl-Jawahri A, Forst D, Fenech A, Brenner KO, Jankowski AL, Waldman L, Sereno I, Nipp R, Greer JA, Traeger L, Jackson V, Temel J. Relationship Between Perceptions of Treatment Goals and Psychological Distress in Patients With Advanced Cancer. J Natl Compr Canc Netw. 2020 Jul;18(7):849-855. doi: 10.6004/jnccn.2019.7525. PMID 32634779