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Studies

Interventional Recruiting

NCT07312760 on ClinicalTrials.gov

Existential Distress in Advanced Cancer: Comparing a Short-term Psychodynamic Psychotherapy (ORPHYS) to Treatment as Usual (TAU)

Official title: Existential Distress in Advanced Cancer: Pragmatic Randomized Controlled Trial of a Short-term Psychodynamic Psychotherapy (ORPHYS) Compared to Treatment as Usual (TAU)

  • Sponsor: University Medical Center Hamburg-Eppendorf
  • Collaborators: University Düsseldorf, Wuerzburg University Hospital, University of Kassel
  • Enrollment: 160 (Estimated)
  • Study start: 2025-10-24 (Actual)
  • Primary completion: 2026-12-01 (Estimated)
  • Study completion: 2027-12-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • InterventionModelDescription: Model Description
  • Masking: Double (Investigator, Outcomes Assessor)
  • PrimaryPurpose: Treatment

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.

Conditions

  • Advanced Cancer, Various, NOS

Intervention / Treatment

  • Behavioral: ORPHYS (ShORt-term psychodynamic psychotherapy in serious PHYSical illness)
  • Behavioral: TAU (Treatment As Usual: Standard psycho-oncological care)

Primary Outcome Measures

  • Demoralization assessed via the Demoralization Scale-II (DS-II; Robinson et al., 2016; Koranyi et al., 2021) (Day 0, Month 3, Month 6, Month 9, Month 12)
    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.

Countries

Germany

Locations and Investigators

  • Clinical Institute for Psychosomatic Medicine and Psychotherapy, University Medical Center Düsseldorf, Düsseldorf, Germany (Recruiting)
    • André Karger, Dr.
  • University Medical Center Hamburg-Eppendorf, Hamburg, Germany (Recruiting)
    • Sigrun Vehling, PD Dr.
    • Rebecca Philipp, PhD
  • Psychosomatics, Psychotherapy and Psychooncology, Medicine II, University of Würzburg, Würzburg, Germany (Recruiting)
    • Imad Maatouk, Prof. Dr.