Carcinoma, Malignant Neoplasm, Palliative Care
Conditions
Keywords
Advanced Cancer, Death anxiety, Demoralization, Existential distress, Mental disorders
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.
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 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.
Interventions
BEHAVIORALShort-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.
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Pre-Post Design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment feasibility | through study completion, an average of 6 months | Will be assessed via semi-structured qualitative interviews. |
| Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) | 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 | 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 | through study completion, an average of 6 months | Will be assessed via qualitative analysis of therapeutic session protocols and audio recordings. |
| Therapeutic competence | through study completion, an average of 6 months | Will be assessed via qualitative analysis of supervision protocols. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Interpersonal problems | Baseline, 3-, 6-, 9- and 12-months follow up | Will be assessed via inventory for assessment of interpersonal problems (IIP-D-32, Thomas, Brähler & Strauß, 2011). |
| Therapeutic process | through study completion, an average of 6 months | Will be assessed via semi-structured qualitative interviews. |
| Therapeutic alliance II | 3-, 6- 9- and 12-months follow-up | Will be assessed via Helping Alliance Questionnaire (HAQ, Luborsky et al., 1996) (IIP-D-32, Thomas, Brähler & Strauß, 2011) for patients and therapists. |
| Therapeutic alliance I | 3-, 6- 9- and 12-months follow-up | Will be assessed via California Psychotherapy Alliance Scales (CALPAS, Marmar & Gaston, 1989) for patients and therapists. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Dignity related distress | Baseline, 3-, 6-, 9- and 12-months-follow-up | Will be assessed using the Sense of Dignity Item (SDI, Chochinov et al., 2002) and the Patient Dignity Inventory (PDI, Chochinov, 2008). |
| Meaningfulness in life and crisis of meaning | Baseline, 3-, 6-, 9- and 12-months-follow-up | Will be assessed using the Sources of Meaning and Meaning in Life Questionnaire (SoMe, Schnell, 2009). |
| Desire for hastened death | Baseline, 3-, 6-, 9- and 12-months-follow-up | Will be assessed using the short form of the Schedule of Attitudes Toward Hastened Death (SAHD-A, Kolva et al., 2017). |
| Coping resources | Baseline, 3-, 6-, 9- and 12-months-follow-up | Will be assessed using subscales (coping competence, adaptability) of the questionnaire for patient competence in coping with cancer (PCQ, Aderhold et al., 2019). |
| Need for and utilisation of psychosocial support for existential distress | Baseline, 3-, 6-, 9- and 12-months-follow-up | Will be assessed using the Structured questionnaire of psychosocial support needs for existential distress. |
| Quality of life at the end of life | Baseline, 3-, 6-, 9- and 12-months-follow-up | Will be assessed using a subscale (Life completion) of the Quality of Life at the End of Life-Cancer-Psychosocial Questionnaire (Qual-EC-P). |
| Suicidal ideation | Baseline, 3-, 6-, 9- and 12-months-follow-up | Will be assessed using the Beck Scale for Suicidal Ideation (BSS, Kliem & Brähler, 2015). |
| Coping and Demoralisation | a) Baseline and 6-months follow-up, b) Baseline, 3-, 6-, 9- and 12-months-follow-up | 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). |
| Prevalence of adjustment disorder | Baseline and 6-months follow-up | 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). |
| Aggressiveness of care | 4 weeks prior to death | 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. |
| Prevalence of affective and anxiety disorders | Baseline and 6-months follow-up | Will be assessed using the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (SCID-5, Beesdo-Baum et al., 2019). |
| Death Anxiety | Baseline, 3-, 6-, 9- and 12-months-follow-up | Will be assessed using the Death Anxiety and Distress Scale (DADDS, Krause etal., 2015). |
| Perceived Relatedness | Baseline, 3-, 6-, 9- and 12-months-follow-up | Will be assessed using Subscales (Dependence, Relatedness) of the Depressive Experience Questionnaire (DEQ, Blatt, D'Afflitti & Quinlan, 1976; Blatt et al., 1982). |
| End-of-life preparation and adaption | Baseline, 3-, 6-, 9- and 12-months-follow-up | Will be assessed using the Revised Loss Orientation and Life Engagement in Advanced Cancer Scale (LOLES, Vehling et al., 2018). |
Countries
Germany
Outcome results
None listed