NCT05520281

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 29, 2022

Completed
17 days until next milestone

Study Start

First participant enrolled

September 15, 2022

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 6, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 6, 2025

Completed
Last Updated

December 15, 2025

Status Verified

December 1, 2025

Enrollment Period

2.9 years

First QC Date

August 22, 2022

Last Update Submit

December 7, 2025

Conditions

Malignant NeoplasmCarcinomaPalliative Care

Keywords

Advanced CancerDeath anxietyDemoralizationExistential distressMental disorders

Outcome Measures

Primary Outcomes (5)

  • 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).

    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).

    through study completion, an average of 6 months

  • Treatment adherence

    Will be assessed via qualitative analysis of therapeutic session protocols and audio recordings.

    through study completion, an average of 6 months

  • Therapeutic competence

    Will be assessed via qualitative analysis of supervision protocols.

    through study completion, an average of 6 months

  • Treatment feasibility

    Will be assessed via semi-structured qualitative interviews.

    through study completion, an average of 6 months

Secondary Outcomes (4)

  • Therapeutic alliance I

    3-, 6- 9- and 12-months follow-up

  • Interpersonal problems

    Baseline, 3-, 6-, 9- and 12-months follow up

  • Therapeutic process

    through study completion, an average of 6 months

  • Therapeutic alliance II

    3-, 6- 9- and 12-months follow-up

Other Outcomes (14)

  • Desire for hastened death

    Baseline, 3-, 6-, 9- and 12-months-follow-up

  • Suicidal ideation

    Baseline, 3-, 6-, 9- and 12-months-follow-up

  • Coping and Demoralisation

    a) Baseline and 6-months follow-up, b) Baseline, 3-, 6-, 9- and 12-months-follow-up

  • +11 more other outcomes

Study Arms (1)

Patients

EXPERIMENTAL

Adult patients across all phases of advanced disease (UICC stage IV solid tumor) from diagnosis to terminal stages

Behavioral: Short-term psychodynamic psychotherapy for patients with serious physical illness (ORPHYS)

Interventions

Short-term psychodynamic psychotherapy for patients with serious physical illness (ORPHYS)BEHAVIORAL

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.

Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

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

Düsseldorf, 40225, Germany

Location

University Medical Center Hamburg Eppendorf, Department of Medical Psychology

Hamburg, 20246, Germany

Location

Institute of Social Work, University of Kassel

Kassel, 34127, Germany

Location

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

Würzburg, 97080, Germany

Location

MeSH Terms

Conditions

NeoplasmsCarcinomaNecrophobiaMental Disorders

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Sigrun Vehling, PD, PhD

    Universitätsklinikum Hamburg-Eppendorf

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Pre-Post Design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2022

First Posted

August 29, 2022

Study Start

September 15, 2022

Primary Completion

August 6, 2025

Study Completion

August 6, 2025

Last Updated

December 15, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

DE(4)