Carcinoma Clinical Trial
— ORPHYSOfficial 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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Universitätsklinikum Hamburg-Eppendorf |
Germany,
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 |
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