RECRUITINGINTERVENTIONAL

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)

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 willing to sign a consent form and complete self-report questionnaires Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

BEHAVIORAL

ORPHYS (ShORt-term psychodynamic psychotherapy in serious PHYSical illness)

ORPHYS is a manualized individual psychotherapy that was specifically designed for patients with serious physical illness (Philipp et al., 2024). Patients receive 15-31 weekly therapy sessions of 50 minutes length. ORPHYS takes into account the individual meaning of illness in the context of internalized motives and fears. ORPHYS aims to help patients gain consciousness of related existential conflict. The treatment supports reflection on current relational experiences in the context of realistic, illness-related fears. Identifying patients' dysfunctional relationship patterns, which represent patients' unconscious fantasies about the responsiveness and availability of others and making them accessible to the patient during therapy is expected to increase mentalization and, thus, emotional flexibility to balance extreme affective states. Emotional containment and supportive interventions are the basis for ORPHYS.

BEHAVIORAL

TAU (Treatment As Usual: Standard psycho-oncological care)

Patients receive routine psycho-oncological care as provided by the study centers. TAU includes individual sessions provided by physicians or master-level psychologists with experience in psycho-oncological care. There is no restriction on the minimum or maximum number of sessions.

Locations (3)

Clinical Institute for Psychosomatic Medicine and Psychotherapy, University Medical Center Düsseldorf

Düsseldorf, Germany

University Medical Center Hamburg-Eppendorf

Hamburg, Germany

Psychosomatics, Psychotherapy and Psychooncology, Medicine II, University of Würzburg

Würzburg, Germany