Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05520281
Other study ID # DKH70113404-2
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 15, 2022
Est. completion date June 30, 2025

Study information

Verified date May 2023
Source Universitätsklinikum Hamburg-Eppendorf
Contact Sigrun Vehling, PD, PhD
Phone +4940741056805
Email s.vehling@uke.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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 1. analyse the feasibility of the treatment, and 2. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date June 30, 2025
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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.

Locations

Country Name City State
Germany Clinical Institute for Psychosomatic Medicine and Psychotherapy, University Medical Center Düsseldorf Düsseldorf
Germany University Medical Center Hamburg Eppendorf, Department of Medical Psychology Hamburg
Germany Institute of Social Work, University of Kassel Kassel
Germany Psychosomatics, Psychotherapy and Psychooncology, Medicine II, University of Würzburg Würzburg

Sponsors (1)

Lead Sponsor Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Other Desire for hastened death Will be assessed using the short form of the Schedule of Attitudes Toward Hastened Death (SAHD-A, Kolva et al., 2017). Baseline, 3-, 6-, 9- and 12-months-follow-up
Other Suicidal ideation Will be assessed using the Beck Scale for Suicidal Ideation (BSS, Kliem & Brähler, 2015). Baseline, 3-, 6-, 9- and 12-months-follow-up
Other Coping and Demoralisation Will be assessed using the a) Structured Interview for Psychological Adjustment and Demoralisation (Bobevski & Kissane, 2019) and b) Demoralisation Scale-II (DS-II, Robinson et al., 2016). a) Baseline and 6-months follow-up, b) Baseline, 3-, 6-, 9- and 12-months-follow-up
Other Prevalence of adjustment disorder Will be assessed according to International Classification of Diseases (ICD-11) using the Adjustment Disorder Module of the CIDI (Composite International Diagnostic Interview, (Perkonigg et al., 2018). Baseline and 6-months follow-up
Other Aggressiveness of care Will be assessed according to the criteria by Earle et al., 2003: receipt of chemotherapy in the last two weeks of life, emergency hospital admissions or intensive-care treatment during the last month of life. Will be obtained from medical chart reviews for deceased patients. 4 weeks prior to death
Other Prevalence of affective and anxiety disorders Will be assessed using the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (SCID-5, Beesdo-Baum et al., 2019). Baseline and 6-months follow-up
Other Death Anxiety Will be assessed using the Death Anxiety and Distress Scale (DADDS, Krause etal., 2015). Baseline, 3-, 6-, 9- and 12-months-follow-up
Other Perceived Relatedness Will be assessed using Subscales (Dependence, Relatedness) of the Depressive Experience Questionnaire (DEQ, Blatt, D'Afflitti & Quinlan, 1976; Blatt et al., 1982). Baseline, 3-, 6-, 9- and 12-months-follow-up
Other End-of-life preparation and adaption Will be assessed using the Revised Loss Orientation and Life Engagement in Advanced Cancer Scale (LOLES, Vehling et al., 2018). Baseline, 3-, 6-, 9- and 12-months-follow-up
Other Dignity related distress Will be assessed using the Sense of Dignity Item (SDI, Chochinov et al., 2002) and the Patient Dignity Inventory (PDI, Chochinov, 2008). Baseline, 3-, 6-, 9- and 12-months-follow-up
Other Meaningfulness in life and crisis of meaning Will be assessed using the Sources of Meaning and Meaning in Life Questionnaire (SoMe, Schnell, 2009). Baseline, 3-, 6-, 9- and 12-months-follow-up
Other Quality of life at the end of life Will be assessed using a subscale (Life completion) of the Quality of Life at the End of Life-Cancer-Psychosocial Questionnaire (Qual-EC-P). Baseline, 3-, 6-, 9- and 12-months-follow-up
Other Coping resources Will be assessed using subscales (coping competence, adaptability) of the questionnaire for patient competence in coping with cancer (PCQ, Aderhold et al., 2019). Baseline, 3-, 6-, 9- and 12-months-follow-up
Other Need for and utilisation of psychosocial support for existential distress Will be assessed using the Structured questionnaire of psychosocial support needs for existential distress. Baseline, 3-, 6-, 9- and 12-months-follow-up
Primary 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
Primary 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
Primary Treatment adherence Will be assessed via qualitative analysis of therapeutic session protocols and audio recordings. through study completion, an average of 6 months
Primary Therapeutic competence Will be assessed via qualitative analysis of supervision protocols. through study completion, an average of 6 months
Primary Treatment feasibility Will be assessed via semi-structured qualitative interviews. through study completion, an average of 6 months
Secondary Therapeutic alliance I Will be assessed via California Psychotherapy Alliance Scales (CALPAS, Marmar & Gaston, 1989) for patients and therapists. 3-, 6- 9- and 12-months follow-up
Secondary Interpersonal problems Will be assessed via inventory for assessment of interpersonal problems (IIP-D-32, Thomas, Brähler & Strauß, 2011). Baseline, 3-, 6-, 9- and 12-months follow up
Secondary Therapeutic process Will be assessed via semi-structured qualitative interviews. through study completion, an average of 6 months
Secondary 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. 3-, 6- 9- and 12-months follow-up
See also
  Status Clinical Trial Phase
Recruiting NCT05283226 - Study to Evaluate the Safety and Efficacy of Oral NRC-2694-A in Combination With Paclitaxel in Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma, Who Progressed on or After Immune Checkpoint Inhibitor Therapy Phase 2
Active, not recruiting NCT04362072 - Study of Lorlatinib In People With ALK-positive Non-small Cell Lung Cancer Phase 4
Completed NCT04033991 - Study of Patients With Metastatic and/or Advanced Renal Cell Carcinoma, Treated With Sunitinib/Axitinib.
Recruiting NCT02292641 - Beyond TME Origins N/A
Not yet recruiting NCT02907606 - Urinary Circulating Tumor DNA Detection in Non-small Cell Lung Cancer: a Prospective Study N/A
Completed NCT02507544 - A Safety and Pharmacokinetic Study of TRX-818 Administered Orally to Patients With Advanced Cancer Phase 1
Completed NCT01942200 - A Non Interventional Study With Oxaliplatin Onkovis (Oxaliplatin) Utilized for the Treatment of Cancer
Completed NCT01061645 - Study of MOC31-PE in Antigen Positive Carcinomas Phase 1
Terminated NCT00557596 - A Phase 1-2, XIAP Antisense AEG35156 With Gemcitabine in Patients With Advanced Pancreatic Cancer Phase 1/Phase 2
Completed NCT00532155 - A Study of Aflibercept Versus Placebo in Patients With Second-Line Docetaxel for Locally Advanced or Metastatic Non-Small-Cell Lung Cancer Phase 3
Completed NCT00216372 - Efficacy and Safety of Lanreotide Microparticles as Palliative Treatment in Peritoneal Carcinomatosis Phase 3
Recruiting NCT06022757 - Study of XNW5004 Tablet in Combination With KEYTRUDA® (Pembrolizumab) in Subjects With Advanced Solid Tumors Who Failed Standard Treatments (KEYNOTE F19) Phase 1/Phase 2
Recruiting NCT05752357 - The Role of Pre-operative and Post-operative Circulating Tumor Cells in Gastric Cancer.
Not yet recruiting NCT05023928 - Tumor Antigen-sensitized DC Vaccine as an Adjuvant Therapy for Esophagus Cancer Phase 1
Completed NCT00446446 - PRISM (Panitumumab Regimen In Second-line Monotherapy of Head and Neck Cancer) Phase 2
Recruiting NCT04566952 - Anlotinib Combined With Dose-reduced Olaparib in Patients With Platinum-Sensitive Recurrent Ovarian Cancer Phase 2
Not yet recruiting NCT06112041 - The Prospective Clinical Study of Precision PRaG Therapy in Elderly Patients With Advanced Solid Malignant Tumors (PRaG9.0) Phase 2
Completed NCT03562897 - Evaluation of Ocoxin-Viusid® in Advanced or Metastatic Ovarian Epithelial Cancer Phase 2
Recruiting NCT06013111 - An Exploratory Clinical Study Evaluating the Safety and Efficacy of Anti-CEA-CAR-T Cells Injection in Patients With CEA+ Locally Advanced and/or Metastatic Solid Tumors Phase 1
Active, not recruiting NCT04600206 - Existential Distress in Patients With Advanced Cancer and Their Caregivers