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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.
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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients | Experimental | Adult patients across all phases of advanced disease (UICC stage IV solid tumor) from diagnosis to terminal stages |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Interpersonal problems |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Suicidal ideation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sigrun Vehling, PD, PhD | Universitätsklinikum Hamburg-Eppendorf | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Institute for Psychosomatic Medicine and Psychotherapy, University Medical Center Düsseldorf | Düsseldorf | 40225 | Germany | |||
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D002277 | Carcinoma |
| C000719207 | Necrophobia |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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Pre-Post Design
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|
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 |
| Therapeutic process | Will be assessed via semi-structured qualitative interviews. | 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. | 3-, 6- 9- and 12-months follow-up |
Will be assessed using the Beck Scale for Suicidal Ideation (BSS, Kliem & Brähler, 2015).
| Baseline, 3-, 6-, 9- and 12-months-follow-up |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| University Medical Center Hamburg Eppendorf, Department of Medical Psychology |
| Hamburg |
| 20246 |
| Germany |
| Institute of Social Work, University of Kassel | Kassel | 34127 | Germany |
| Psychosomatics, Psychotherapy and Psychooncology, Medicine II, University of Würzburg | Würzburg | 97080 | Germany |