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.
Background: As improvements in systemic anti-cancer treatments have extended survival, patients with advanced cancer and their family caregivers face the existential tension between engaging in life and coping with uncertainty about illness trajectory and course of treatment. For a subgroup, this tension is associated with overwhelming fear and existential distress. Existential distress is often characterized by demoralization, a state of despair and hopelessness in which coping skills are exhausted and patients are unable to see something positive in the future. Such adjustment difficulties may increase the risk of poor quality of life and suicidality, as well as impair prognostic awareness and patient-clinician communication. Despite growing interest in open conversations about end-of-life issues, little is known about how clinicians can best support patients experiencing high levels of existential distress in order to facilitate psychological adaptation at the end of life. Objective: To evaluate the effectiveness of ORPHYS (ShORt-term psychodynamic psychotherapy in serious PHYSical illness) in a pragmatic randomized controlled trial. The intervention group receives 15-31 sessions of ORPHYS, a manualized individual psychotherapy that flexibly integrates uncovering and holding treatment elements. The control group receives usual psycho-oncological care (TAU). The primary outcome is demoralization as assessed by the Demoralization Scale-II. Secondary outcomes include diagnosis of affective, anxiety and stress-related disorders, death anxiety, dignity-related distress, and quality of life. Methods: The investigators will conduct a two-arm parallel randomized controlled trial with an active control group. Patients will be assessed pre-intervention and after 3, 6, 9, and 12 months. The target sample size is 160 participants before randomization. The investigators will recruit patients with stage III/IV solid tumors or advanced hematological cancer and clinically significant existential distress from psycho-oncology clinics and referring oncologists at Hamburg, Düsseldorf, and Würzburg Comprehensive Cancer Centers. Outcome assessments will be conducted via diagnostic interviews and self-report questionnaires. Linear mixed models will examine outcome differences between trial arms. A confirmatory test of the group contrast at 6 months-follow-up will be conducted. Discussion: Due to an aging population and prolonged survival, there is a growing demand to help patients deal with existential challenges. The study will contribute to knowledge about how clinicians can best help patients with advanced cancer who substantially struggle with uncertainty at the end of life.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
160
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.
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.
Clinical Institute for Psychosomatic Medicine and Psychotherapy, University Medical Center Düsseldorf
Düsseldorf, Germany
RECRUITINGUniversity Medical Center Hamburg-Eppendorf
Hamburg, Germany
RECRUITINGPsychosomatics, Psychotherapy and Psychooncology, Medicine II, University of Würzburg
Würzburg, Germany
RECRUITINGDemoralization assessed via the Demoralization Scale-II (DS-II; Robinson et al., 2016; Koranyi et al., 2021)
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.
Time frame: Day 0, Month 3, Month 6, Month 9, Month 12
Diagnosis of affective disorders, anxiety disorders, trauma- and stressor-related disorders assessed via Diagnostic and Statistical Manual of Mental Disorders-5 (SCID-5; Beesdo-Baum, 2019)
Presence of the following mental disorders is indicated with "yes" or "no" based on SCID-5 criteria: Major depression, Persistent depressive disorder, Bipolar diorders, Panic disorder, Agoraphobia, Social phobia, Generalized anxiety disorder, Simple phobia, Posttraumatic stress disorder
Time frame: Day 0, Month 6, Month 12
Diagnosis of stressor-related disorders assessed via CIDI Adjustment Disorder Module (Perkonigg et al., 2019)
Presence of Adjustment disorder is indicated with "yes" or "no" based on ICD-11 criteria.
Time frame: Day 0, Month 6, Month 12
Death anxiety assessed via Death and Dying Distress Scale (DADDS; Lo et al., 2011)
Items are scored on a 6-point Likert scale from 0 (no distress) to 5 (extreme distress), with a total score ranging from 0 to 75. Higher scores indicate higher levels of death anxiety.
Time frame: Day 0, Month 3, Month 6, Month 9, Month 12
Dignity-related distress assessed via the Sense of Dignity Item (SDI; Chochinov et al., 2002)
Item is scord on a 7-point Likert-scale from 0 (no sense of loss of dignity) to 6 (extreme sense of loss of dignity).
Time frame: Day 0, Month 3, Month 6, Month 9, Month 12
Dignity-related distress assessed via the Patient Dignity Inventory (PDI; Chochinov et al., 2008)
The following subscales of the PDI are used: 1) Physical Symptom Distress, 2) Body Image and Loss of Autonomy. Items are scored on a 5-point Likert-scale from 0 (no problem) to 5 (an overwhelming problem). Higher scores indicate a higher sense of loss of dignity.
Time frame: Day 0, Month 3, Month 6, Month 9, Month 12
Quality of life assessed via the Quality of Life at the End of Life-Cancer-Psychosocial Questionnaire (QUAL-EC-P)
Subscales used: 1) Life completion, 2) Preparation for the end of life. Items are scored on a 5-point Likert scale from 0 (not at all) to 4 (completely), with a total score ranging from 0 to 36. Higher scores indicate higher quality of life.
Time frame: Day 0, Month 3, Month 6, Month 9, Month 12
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