NCT07312760 Existential Distress in Advanced Cancer: Comparing a Short-term Psychodynamic Psychotherapy (ORPHYS) to Treatment as Usual (TAU)
| NCT ID | NCT07312760 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitätsklinikum Hamburg-Eppendorf |
| Condition | Advanced Cancer, Various, NOS |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2025-10-24 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 160 participants in total. It began in 2025-10-24 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07312760 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced Cancer, Various, NOS. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07312760 currently recruiting?
Yes, NCT07312760 is actively recruiting participants. Contact the research team at s.vehling@uke.de for enrollment information.
Where is the NCT07312760 trial being conducted?
This trial is being conducted at Düsseldorf, Germany, Hamburg, Germany, Würzburg, Germany.
Who is sponsoring the NCT07312760 clinical trial?
NCT07312760 is sponsored by Universitätsklinikum Hamburg-Eppendorf. The trial plans to enroll 160 participants.
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