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.