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

NCT07312760 | Recruiting DMC

• 1 other identifier: DKH70116803
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 3

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

Keywords

Advanced cancer; Psycho-Oncology; Psychodynamic Psychotherapy; Demoralization; End-of-life; Randomized Controlled Trial; Existential Distress; Psychological Intervention

Outcome Measures

Primary Outcomes (1)

• Demoralization 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.

  Day 0, Month 3, Month 6, Month 9, Month 12

Secondary Outcomes (6)

• 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)

  Day 0, Month 6, Month 12

• Diagnosis of stressor-related disorders assessed via CIDI Adjustment Disorder Module (Perkonigg et al., 2019)

  Day 0, Month 6, Month 12

• Death anxiety assessed via Death and Dying Distress Scale (DADDS; Lo et al., 2011)

  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)

  Day 0, Month 3, Month 6, Month 9, Month 12

• Dignity-related distress assessed via the Patient Dignity Inventory (PDI; Chochinov et al., 2008)

  Day 0, Month 3, Month 6, Month 9, Month 12

Other Outcomes (25)

• Prognostic awareness assessed via semistructured interview for subjective goal of oncological treatment (El-Jawahri et al., 2020; DeMartini et al., 2019)

  Day 0, Month 6, Month 12

• Subjective experience of end-of-life discussions with health care provider assessed via semi-structured interview (El-Jawahri et al., 2020)

  Day 0, Month 3, Month 6, Month 9, Month 12

• Perceived relationship with healthcare provider assessed via Quality of Life at the End of Life-Cancer-Psychosocial Questionnaire (QUAL-EC-P)

  Day 0, Month 3, Month 6, Month 9, Month 12

Study Arms (2)

ORPHYS (ShORt term psychodynamic psychotherapy adapted to serious PHYSical illness)

EXPERIMENTAL

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

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

ACTIVE COMPARATOR

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

Interventions

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

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.

ORPHYS (ShORt term psychodynamic psychotherapy adapted to serious PHYSical illness)

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

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead
• University Düsseldorf: collaborator
• Wuerzburg University Hospital: collaborator
• University of Kassel: collaborator

Study Sites (3)

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

Düsseldorf, 40225, Germany

RECRUITING

University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

RECRUITING

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

Würzburg, 97080, Germany

RECRUITING

Related Publications (11)

• Philipp R, Walbaum C, Lindner R, Karger A, Maatouk I, Dinger U, Vehling S. [ORPHYS - Treatment Manual for a Short-Term Psychodynamic Psychotherapy in Patients with Serious Physical Illness]. Psychother Psychosom Med Psychol. 2024 Aug;74(8):345-351. doi: 10.1055/a-2322-8596. Epub 2024 Jun 17. German.

  PMID: 38885656 BACKGROUND

• Perkonigg A, Strehle J, Beesdo-Baum K, Lorenz L, Hoyer J, Venz J, Maercker A. Reliability and Validity of a German Standardized Diagnostic Interview Module for ICD-11 Adjustment Disorder. J Trauma Stress. 2021 Apr;34(2):275-286. doi: 10.1002/jts.22597. Epub 2020 Nov 5.

  PMID: 33151596 BACKGROUND

• Huber J, Nikendei C, Ehrenthal JC, Schauenburg H, Mander J, Dinger U. Therapeutic Agency Inventory: Development and psychometric validation of a patient self-report. Psychother Res. 2019 Oct;29(7):919-934. doi: 10.1080/10503307.2018.1447707. Epub 2018 Mar 20.

  PMID: 29557306 BACKGROUND

• Brahler E, Horowitz LM, Kordy H, Schumacher J, Strauss B. [Validation of the Inventory for Interpersonal Problems (IIP). Results of a representative study in East and West Germany]. Psychother Psychosom Med Psychol. 1999 Nov;49(11):422-31. German.

  PMID: 10593141 BACKGROUND

• Galushko M, Strupp J, Walisko-Waniek J, Hahn M, Loffert S, Ernstmann N, Pfaff H, Radbruch L, Nauck F, Ostgathe C, Voltz R. Validation of the German version of the Schedule of Attitudes Toward Hastened Death (SAHD-D) with patients in palliative care. Palliat Support Care. 2015 Jun;13(3):713-23. doi: 10.1017/S1478951514000492. Epub 2014 May 22.

  PMID: 24849188 BACKGROUND

• El-Jawahri A, Forst D, Fenech A, Brenner KO, Jankowski AL, Waldman L, Sereno I, Nipp R, Greer JA, Traeger L, Jackson V, Temel J. Relationship Between Perceptions of Treatment Goals and Psychological Distress in Patients With Advanced Cancer. J Natl Compr Canc Netw. 2020 Jul;18(7):849-855. doi: 10.6004/jnccn.2019.7525.

  PMID: 32634779 BACKGROUND

• Conrad M, Engelmann D, Friedrich M, Scheffold K, Philipp R, Schulz-Kindermann F, Harter M, Mehnert A, Koranyi S. [Assessment of Couples' Communication in Patients with Advanced Cancer: Validation of a German Version of the Couple Communication Scale (CCS)]. Psychother Psychosom Med Psychol. 2019 May;69(5):189-196. doi: 10.1055/a-0583-4837. Epub 2018 Apr 13. German.

  PMID: 29653458 BACKGROUND

• Hack TF, McClement SE, Chochinov HM, Cann BJ, Hassard TH, Kristjanson LJ, Harlos M. Learning from dying patients during their final days: life reflections gleaned from dignity therapy. Palliat Med. 2010 Oct;24(7):715-23. doi: 10.1177/0269216310373164. Epub 2010 Jul 6.

  PMID: 20605851 BACKGROUND

• Abedini NC, Hechtman RK, Singh AD, Khateeb R, Mann J, Townsend W, Chopra V. Interventions to reduce aggressive care at end of life among patients with cancer: a systematic review. Lancet Oncol. 2019 Nov;20(11):e627-e636. doi: 10.1016/S1470-2045(19)30496-6.

  PMID: 31674321 BACKGROUND

• Vehling S, Gerstorf D, Schulz-Kindermann F, Oechsle K, Philipp R, Scheffold K, Harter M, Mehnert A, Lo C. The daily dynamics of loss orientation and life engagement in advanced cancer: A pilot study to characterise patterns of adaptation at the end of life. Eur J Cancer Care (Engl). 2018 Jul;27(4):e12842. doi: 10.1111/ecc.12842. Epub 2018 Apr 27.

  PMID: 29700876 BACKGROUND

• Koranyi S, Hinz A, Hufeld JM, Hartung TJ, Quintero Garzon L, Fendel U, Letsch A, Rose M, Esser P, Mehnert-Theuerkauf A. Psychometric Evaluation of the German Version of the Demoralization Scale-II and the Association Between Demoralization, Sociodemographic, Disease- and Treatment-Related Factors in Patients With Cancer. Front Psychol. 2021 Nov 24;12:789793. doi: 10.3389/fpsyg.2021.789793. eCollection 2021.

  PMID: 34899543 BACKGROUND

MeSH Terms

Conditions

Pyloric Stenosis, Hypertrophic; Death

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Pyloric Stenosis; Gastric Outlet Obstruction; Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Sigrun Vehling, PD Dr.

CONTACT

+4940741056805; s.vehling@uke.de

Rebecca Philipp, PhD

CONTACT

+4940741056203; r.philipp@uke.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Masking Description
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Model Description

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: December 31, 2025
• Study Start: October 24, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3)