ORPHYS short-term psychodynamic psychotherapy versus usual psycho‑oncological care for existential distress in advanced cancer
Official title: Existential Distress in Advanced Cancer: Pragmatic Randomized Controlled Trial of a Short-term Psychodynamic Psychotherapy (ORPHYS) Compared to Treatment as Usual (TAU)
Run by Universitätsklinikum Hamburg-Eppendorf · NCT07312760 · Data updated 2026-11-12
This program will test whether ORPHYS, a short-term psychodynamic psychotherapy, can help reduce existential distress in people with advanced cancer compared with usual psycho‑oncological care.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 160 (estimated) |
| Sponsor | Universitätsklinikum Hamburg-Eppendorf Academic / other |
| Locations | 3 sites (Düsseldorf and 2 other locations) |
| Status | Recruiting |
| Started | October 24, 2025 |
| Main results expected | December 2026 |
| Study ends | December 2027 |
| Registry record updated | December 31, 2025 |
| Trial ID | NCT07312760 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with UICC stage III/IV solid tumors or advanced hematologic cancers who have significant existential distress (loss of hope, demoralization, death anxiety, loneliness) and can attend outpatient German‑language psychotherapy without concurrent psychotherapeutic care.
✕Probably not a fit
People with acute suicidality, active psychotic disorders or substance dependence, inability to participate in psychotherapy, or insufficient German proficiency are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a pragmatic randomized trial comparing ORPHYS, a manualized individual short-term psychodynamic psychotherapy, to treatment as usual (standard psycho‑oncological care) in patients with advanced cancer who report high existential distress. The ORPHYS intervention is delivered in 15–31 outpatient sessions and integrates uncovering and holding therapeutic elements. The primary outcome is demoralization measured by the Demoralization Scale‑II, with secondary outcomes addressing quality of life and related psychological measures. Eligible participants are adults with UICC stage III/IV solid tumors or advanced hematologic cancers who can attend German‑language outpatient psychotherapy and are not receiving other concurrent psychotherapeutic treatment.
Why it matters
Potential benefit: If successful, ORPHYS could reduce demoralization and improve quality of life, coping, and end‑of‑life communication for people with advanced cancer.
How similar studies have gone: Other psychotherapeutic approaches for existential distress in advanced cancer, such as meaning‑centered therapy and dignity therapy, have shown benefits, but short‑term psychodynamic approaches like ORPHYS are relatively novel and less extensively tested.
Who can join: the full rules
Show full inclusion / exclusion 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: * 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
Where it's running
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Clinical Institute for Psychosomatic Medicine and Psychotherapy, University Medical Center Düsseldorf
Düsseldorf, Germany Recruiting -
University Medical Center Hamburg-Eppendorf
Hamburg, Germany Recruiting -
Psychosomatics, Psychotherapy and Psychooncology, Medicine II, University of Würzburg
Würzburg, Germany Recruiting
Study contacts
- Study coordinator: Sigrun Vehling, PD Dr.
- Email: s.vehling@uke.de
- Phone: +4940741056805
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.