Advanced Cancer, Various, NOSNCT07312760
Existential Distress in Advanced Cancer: Comparing a Short-term Psychodynamic Psychotherapy (ORPHYS) to Treatment as Usual (TAU)
A study testing ORPHYS (ShORt-term psychodynamic psychotherapy in serious PHYSical illness) and TAU (Treatment As Usual: Standard psycho-oncological care) in people with Advanced Cancer, Various, NOS, run by Universitätsklinikum Hamburg-Eppendorf at 3 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer, Various, NOS
- What is being tested?
- ORPHYS (ShORt-term psychodynamic psychotherapy in serious PHYSical illness) and TAU (Treatment As Usual: Standard psycho-oncological care)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 3 sitesGermany
- Study dates
- 24 Oct 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany3 sites, 3 recruiting
- Recruiting
Clinical Institute for Psychosomatic Medicine and Psychotherapy, University Medical Center Düsseldorf
Düsseldorf, 40225
André Karger, Dr., +49 (0)211 81 16212, andre.karger@med.uni-duesseldorf.de
- Recruiting
University Medical Center Hamburg-Eppendorf
Hamburg, 20246
Sigrun Vehling, PD Dr., +4940741056805, s.vehling@uke.de
Rebecca Philipp, PhD, +4940741056203, r.philipp@uke.de
- Recruiting
Psychosomatics, Psychotherapy and Psychooncology, Medicine II, University of Würzburg
Würzburg, 97080
Imad Maatouk, Prof. Dr., +49 (0)931 201- 40365, maatouk_i@ukw.de
About this study
Official title: Existential Distress in Advanced Cancer: Pragmatic Randomized Controlled Trial of a Short-term Psychodynamic Psychotherapy (ORPHYS) Compared to Treatment as Usual (TAU)
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.
Read the detailed description
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.
- Conditions
- Advanced Cancer, Various, NOS
- Being tested
- ORPHYS (ShORt-term psychodynamic psychotherapy in serious PHYSical illness), TAU (Treatment As Usual: Standard psycho-oncological care)
- Keywords
- Advanced cancer, Psycho-Oncology, Psychodynamic Psychotherapy, Demoralization, End-of-life, Randomized Controlled Trial, Existential Distress, Psychological Intervention
- Medical subject headings
- Pyloric Stenosis, Hypertrophic, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORPHYS (ShORt-term psychodynamic psychotherapy in serious PHYSical illness)Behavioural
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.
TAU (Treatment As Usual: Standard psycho-oncological care)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| ORPHYS (ShORt term psychodynamic psychotherapy adapted to serious PHYSical illness) | Experimental | Not described Receives: Behavioral: ORPHYS (ShORt-term psychodynamic psychotherapy in serious PHYSical illness) |
| TAU (Treatment As Usual: standard psycho-oncological care) | Active comparator | Not described Receives: Behavioral: TAU (Treatment As Usual: Standard psycho-oncological care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Day 0, Month 3, Month 6, Month 9, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start24 Oct 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Advanced Cancer, Various, NOSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Model Description
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- University Düsseldorf, Wuerzburg University Hospital, University of Kassel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07312760
- Sponsor's protocol ID
- DKH70116803
- Status last verified
- Dec 2025
- First submitted
- 5 Dec 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38885656Perkonigg 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.
PubMed 33151596Huber 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.
PubMed 29557306Brahler 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.
PubMed 10593141Galushko 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.
PubMed 24849188El-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.
PubMed 32634779Conrad 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.
PubMed 29653458Hack 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.
PubMed 20605851Abedini 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.
PubMed 31674321Vehling 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.
PubMed 29700876Koranyi 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.
PubMed 34899543Philipp R, Walbaum C, Bokemeyer C, Dinger U, Harter M, Hemsen B, Holsteg S, Karger A, Koch U, Kriston L, Lezius S, Lindner R, Maatouk I, Oechsle K, Scholl I, Wagner A, Vehling S. Existential distress in advanced cancer: study protocol of a pragmatic randomized controlled trial of a short-term psychodynamic therapy (ORPHYS) compared to usual psycho-oncological treatment (TAU). Trials. 2026 May 7;27(1):358. doi: 10.1186/s13063-026-09744-x.
PubMed 42098804
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Existential Distress in Advanced Cancer: Pragmatic Randomized Controlled Trial of a Short-term Psychodynamic Psychotherapy (ORPHYS) Compared to Treatment as Usual (TAU)
- ClinicalTrials.gov ID
- NCT07312760
- Acronym / sponsor ID
- DKH70116803
- Conditions
- Advanced Cancer, Various, NOS
- Keywords
- Advanced cancer, Psycho-Oncology, Psychodynamic Psychotherapy, Demoralization, End-of-life, Randomized Controlled Trial, Existential Distress, Psychological Intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- University Düsseldorf, Wuerzburg University Hospital, University of Kassel
- Study start
- 24 Oct 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 31 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Model Description
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | ORPHYS (ShORt term psychodynamic psychotherapy adapted to serious PHYSical illness) |
| 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. | Behavioural | TAU (Treatment As Usual: standard psycho-oncological care) |
Primary outcome
Demoralization assessed via the Demoralization Scale-II (DS-II; Robinson et al., 2016; Koranyi et al., 2021)
Time frame: 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.
6 secondary outcomes
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)
Time frame: Day 0, Month 6, Month 12
Diagnosis of stressor-related disorders assessed via CIDI Adjustment Disorder Module (Perkonigg et al., 2019)
Time frame: Day 0, Month 6, Month 12
Death anxiety assessed via Death and Dying Distress Scale (DADDS; Lo et al., 2011)
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)
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)
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)
Time frame: Day 0, Month 3, Month 6, Month 9, Month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Background: PubMed 38885656Philipp 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.
- Background: PubMed 33151596Perkonigg 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.
- Background: PubMed 29557306Huber 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.
- Background: PubMed 10593141Brahler 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.
- Background: PubMed 24849188Galushko 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.
- Background: PubMed 32634779El-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.
- Background: PubMed 29653458Conrad 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.
- Background: PubMed 20605851Hack 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.
- Background: PubMed 31674321Abedini 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.
- Background: PubMed 29700876Vehling 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.
- Background: PubMed 34899543Koranyi 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.
- Derived from this study: PubMed 42098804Philipp R, Walbaum C, Bokemeyer C, Dinger U, Harter M, Hemsen B, Holsteg S, Karger A, Koch U, Kriston L, Lezius S, Lindner R, Maatouk I, Oechsle K, Scholl I, Wagner A, Vehling S. Existential distress in advanced cancer: study protocol of a pragmatic randomized controlled trial of a short-term psychodynamic therapy (ORPHYS) compared to usual psycho-oncological treatment (TAU). Trials. 2026 May 7;27(1):358. doi: 10.1186/s13063-026-09744-x.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ORPHYS (ShORt-term psychodynamic psychotherapy in serious PHYSical illness) and TAU (Treatment As Usual: Standard psycho-oncological care) in people with Advanced Cancer, Various, NOS, run by Universitätsklinikum Hamburg-Eppendorf at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sigrun Vehling, PD Dr. (+4940741056805, s.vehling@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demoralization assessed via the Demoralization Scale-II (DS-II; Robinson et al., 2016; Koranyi et al., 2021) (time frame: Day 0, Month 3, Month 6, Month 9, Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07312760, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.