Malignant NeoplasmORPHYSNCT05520281
Short-term Psychodynamic Psychotherapy in Serious Physical Illness
A study testing Short-term psychodynamic psychotherapy for patients with serious physical illness (ORPHYS) in people with Malignant Neoplasm and Carcinoma, run by Universitätsklinikum Hamburg-Eppendorf at 4 sites in Germany.
Trial summary
Life-threatening physical illness may powerfully re-activate existential conflict. There is little evidence to date on the effectiveness of relationship-focused therapies in this patient group.The aim of this study is to pilot a psychodynamic treatment for patients with advanced cancer and high psychological distress. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Neoplasm, Carcinoma, Palliative Care
- What is being tested?
- Short-term psychodynamic psychotherapy for patients with serious physical illness (ORPHYS)
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 4 sitesGermany
- Study dates
- 15 Sep 2022to 6 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 18 years and older
- UICC stage IV solid tumor
- Informed consent
- Current physical condition that allows for at least 12 therapy sessions
- Indication: Presence of a mental disorder with existential stress and limitations in coping capacity
Who cannot join
- Acute suicidality
- Psychotic disorder (ICD-10: F2 diagnosis)
- Substance dependence or abuse (ICD-10: F1 diagnosis)
- Structural deficits that interfere with attending to regular appointments
- Other psychotherapeutic treatment
- Severe cognitive impairment
- Severe physical impairment
- Insufficient German to give informed consent and complete self-report questionnaires
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Clinical Institute for Psychosomatic Medicine and Psychotherapy, University Medical Center Düsseldorf
Düsseldorf, 40225
University Medical Center Hamburg Eppendorf, Department of Medical Psychology
Hamburg, 20246
Institute of Social Work, University of Kassel
Kassel, 34127
Psychosomatics, Psychotherapy and Psychooncology, Medicine II, University of Würzburg
Würzburg, 97080
About this study
Official title: ORPHYS - Short-term Psychodynamic Psychotherapy in Serious Physical Illness
Life-threatening physical illness may powerfully re-activate existential conflict. There is little evidence to date on the effectiveness of relationship-focused therapies in this patient group.The aim of this study is to pilot a psychodynamic treatment for patients with advanced cancer and high psychological distress.
Read the detailed description
Severely physically ill patients may experience existential distress symptoms including helplessness, hopelessness, death anxiety, perceived burdensomeness and a sense of pointlessness. The latter can significantly interfere with end-of-life care processes and outcomes (receipt of treatment according to preferences, expression of desire for hastened death). So far, empirically tested psychotherapeutic programs in advanced life-threatening illness have predominantly been ultra-short and applied supportive and resource-oriented techniques. Psychodynamic treatment allows to address clinically significant existential distress through its conceptualization from early relational life experiences.
The aim of this study is to pilot a psychodynamic treatment for patients with advanced cancer and high psychological distress.The inverstigators will
- analyse the feasibility of the treatment, and
- investigate changes in process- and patient-relevant outcomes over the course of the treatment
The inverstigators will conduct a single-group pre-post study with five assessment points in which 50 adult patients diagnosed with advanced cancer will receive a manualized psychodynamic short-term therapy. Target parameters are assessed by diagnostic interviews, focus interviews, self-assessment questionnaires as well as electronic patient records. For research objective b) the investigators will compare the intervention group with a matched comparison group of a longitudinal cohort sample (NCT04600206). Matching will be based on stress level, demographic, and medical parameters across the 5 assessment points.
- Conditions
- Malignant Neoplasm, Carcinoma, Palliative Care
- Being tested
- Short-term psychodynamic psychotherapy for patients with serious physical illness (ORPHYS)
- Keywords
- Advanced Cancer, Death anxiety, Demoralization, Existential distress, Mental disorders
- Medical subject headings
- Neoplasms, Carcinoma, Necrophobia, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short-term psychodynamic psychotherapy for patients with serious physical illness (ORPHYS)Behavioural
A short-term psychodynamic therapy that focuses on the special inner and outer situation of patients with a serious physical illness, especially with regard to the importance of relationships in a limited lifetime.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Adult patients across all phases of advanced disease (UICC stage IV solid tumor) from diagnosis to terminal stages Receives: Behavioral: Short-term psychodynamic psychotherapy for patients with serious physical illness (ORPHYS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Will be assessed via Inventory for the Balanced Assessment of Negative Effects of Psychotherapy (INEP, Ladwig, Rief \& Nestoriuc, 2014).
Measured: up to 12-months follow-up
Acceptance
Will be assessed via drop-out rates (number of patients not completing at least 12 sessions) and treatment compliance (number of sessions missed).
Measured: through study completion, an average of 6 months
Treatment adherence
Will be assessed via qualitative analysis of therapeutic session protocols and audio recordings.
Measured: through study completion, an average of 6 months
Therapeutic competence
Will be assessed via qualitative analysis of supervision protocols.
Measured: through study completion, an average of 6 months
Treatment feasibility
Will be assessed via semi-structured qualitative interviews.
Measured: through study completion, an average of 6 months
Secondary outcomes (4)
Therapeutic alliance I
Will be assessed via California Psychotherapy Alliance Scales (CALPAS, Marmar \& Gaston, 1989) for patients and therapists.
Measured: 3-, 6- 9- and 12-months follow-up
Interpersonal problems
Will be assessed via inventory for assessment of interpersonal problems (IIP-D-32, Thomas, Brähler \& Strauß, 2011).
Measured: Baseline, 3-, 6-, 9- and 12-months follow up
Therapeutic process
Will be assessed via semi-structured qualitative interviews.
Measured: through study completion, an average of 6 months
Therapeutic alliance II
Will be assessed via Helping Alliance Questionnaire (HAQ, Luborsky et al., 1996) (IIP-D-32, Thomas, Brähler \& Strauß, 2011) for patients and therapists.
Measured: 3-, 6- 9- and 12-months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start15 Sep 2022
- Primary completion6 Aug 2025
- Study completion6 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Pre-Post Design
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sigrun Vehling, PD, PhD, Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05520281
- Sponsor's protocol ID
- DKH70113404-2
- Acronym
- ORPHYS
- Status last verified
- Dec 2025
- First submitted
- 22 Aug 2022
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ORPHYS - Short-term Psychodynamic Psychotherapy in Serious Physical Illness
- ClinicalTrials.gov ID
- NCT05520281
- Acronym / sponsor ID
- ORPHYS / DKH70113404-2
- Conditions
- Malignant Neoplasm, Carcinoma, Palliative Care
- Keywords
- Advanced Cancer, Death anxiety, Demoralization, Existential distress, Mental disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 6 Aug 2025 (actual)
- Study completion
- 6 Aug 2025 (actual)
- First posted
- 29 Aug 2022 (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.
Life-threatening physical illness may powerfully re-activate existential conflict. There is little evidence to date on the effectiveness of relationship-focused therapies in this patient group.The aim of this study is to pilot a psychodynamic treatment for patients with advanced cancer and high psychological distress.
Detailed description
Severely physically ill patients may experience existential distress symptoms including helplessness, hopelessness, death anxiety, perceived burdensomeness and a sense of pointlessness. The latter can significantly interfere with end-of-life care processes and outcomes (receipt of treatment according to preferences, expression of desire for hastened death). So far, empirically tested psychotherapeutic programs in advanced life-threatening illness have predominantly been ultra-short and applied supportive and resource-oriented techniques. Psychodynamic treatment allows to address clinically significant existential distress through its conceptualization from early relational life experiences.
The aim of this study is to pilot a psychodynamic treatment for patients with advanced cancer and high psychological distress.The inverstigators will
- analyse the feasibility of the treatment, and
- investigate changes in process- and patient-relevant outcomes over the course of the treatment
The inverstigators will conduct a single-group pre-post study with five assessment points in which 50 adult patients diagnosed with advanced cancer will receive a manualized psychodynamic short-term therapy. Target parameters are assessed by diagnostic interviews, focus interviews, self-assessment questionnaires as well as electronic patient records. For research objective b) the investigators will compare the intervention group with a matched comparison group of a longitudinal cohort sample (NCT04600206). Matching will be based on stress level, demographic, and medical parameters across the 5 assessment points.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre-Post Design
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Behavioral: Short-term psychodynamic psychotherapy for patients with serious physical illness (ORPHYS)Adult patients across all phases of advanced disease (UICC stage IV solid tumor) from diagnosis to terminal stages |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years and older
- UICC stage IV solid tumor
- Informed consent
- Current physical condition that allows for at least 12 therapy sessions
- Indication: Presence of a mental disorder with existential stress and limitations in coping capacity
Key exclusion criteria (8 listed)
- Acute suicidality
- Psychotic disorder (ICD-10: F2 diagnosis)
- Substance dependence or abuse (ICD-10: F1 diagnosis)
- Structural deficits that interfere with attending to regular appointments
- Other psychotherapeutic treatment
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 |
|---|---|---|
| Short-term psychodynamic psychotherapy for patients with serious physical illness (ORPHYS)A short-term psychodynamic therapy that focuses on the special inner and outer situation of patients with a serious physical illness, especially with regard to the importance of relationships in a limited lifetime. | Behavioural | Patients |
Primary outcome
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Time frame: up to 12-months follow-up
Will be assessed via Inventory for the Balanced Assessment of Negative Effects of Psychotherapy (INEP, Ladwig, Rief \& Nestoriuc, 2014).
Acceptance
Time frame: through study completion, an average of 6 months
Will be assessed via drop-out rates (number of patients not completing at least 12 sessions) and treatment compliance (number of sessions missed).
Treatment adherence
Time frame: through study completion, an average of 6 months
Will be assessed via qualitative analysis of therapeutic session protocols and audio recordings.
Therapeutic competence
Time frame: through study completion, an average of 6 months
Will be assessed via qualitative analysis of supervision protocols.
Treatment feasibility
Time frame: through study completion, an average of 6 months
Will be assessed via semi-structured qualitative interviews.
4 secondary outcomes
Therapeutic alliance I
Time frame: 3-, 6- 9- and 12-months follow-up
Interpersonal problems
Time frame: Baseline, 3-, 6-, 9- and 12-months follow up
Therapeutic process
Time frame: through study completion, an average of 6 months
Therapeutic alliance II
Time frame: 3-, 6- 9- and 12-months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Malignant Neoplasm
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Not yet recruiting
Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer
Breast Cancer, Breast Neoplasms
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
RecruitingPhase 3
Somatostatin Analogues vs. Observation After Peptide Receptor Radionuclide Therapy (PRRT) in Nonfunctional Neuroendocrine Neoplasms
Neuroendocrine Neoplasm, Gastroenteropancreatic Neuroendocrine Neoplasm
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. This study is not recruiting at the moment.
Sigrun Vehling, PD, PhD principal investigator
Universitätsklinikum Hamburg-Eppendorf
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short-term psychodynamic psychotherapy for patients with serious physical illness (ORPHYS) in people with Malignant Neoplasm and Carcinoma, run by Universitätsklinikum Hamburg-Eppendorf at 4 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 5 inclusion and 8 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: finished, as of the sponsor's last update on 15 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 4 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) (time frame: up to 12-months follow-up). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Dec 2025.