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

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.

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

Sigrun Vehling, PD, PhD

Charlotte Walbaum, MSc

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

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.

Short-term Psychodynamic Psychotherapy in Serious Physical Illness

ORPHYS - Short-term Psychodynamic Psychotherapy in Serious Physical Illness

Will be assessed using the short form of the Schedule of Attitudes Toward Hastened Death (SAHD-A, Kolva et al., 2017).

Will be assessed using the Beck Scale for Suicidal Ideation (BSS, Kliem \& Brähler, 2015).

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).

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).

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.

Will be assessed using the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (SCID-5, Beesdo-Baum et al., 2019).

Will be assessed using the Death Anxiety and Distress Scale (DADDS, Krause etal., 2015).

Will be assessed using Subscales (Dependence, Relatedness) of the Depressive Experience Questionnaire (DEQ, Blatt, D'Afflitti \& Quinlan, 1976; Blatt et al., 1982).

Will be assessed using the Revised Loss Orientation and Life Engagement in Advanced Cancer Scale (LOLES, Vehling et al., 2018).

Will be assessed using the Sense of Dignity Item (SDI, Chochinov et al., 2002) and the Patient Dignity Inventory (PDI, Chochinov, 2008).

Will be assessed using the Sources of Meaning and Meaning in Life Questionnaire (SoMe, Schnell, 2009).

Will be assessed using a subscale (Life completion) of the Quality of Life at the End of Life-Cancer-Psychosocial Questionnaire (Qual-EC-P).

Will be assessed using subscales (coping competence, adaptability) of the questionnaire for patient competence in coping with cancer (PCQ, Aderhold et al., 2019).

Will be assessed using the Structured questionnaire of psychosocial support needs for existential distress.

Will be assessed via Inventory for the Balanced Assessment of Negative Effects of Psychotherapy (INEP, Ladwig, Rief \& Nestoriuc, 2014).

Will be assessed via drop-out rates (number of patients not completing at least 12 sessions) and treatment compliance (number of sessions missed).

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

Will be assessed via qualitative analysis of supervision protocols.

Will be assessed via semi-structured qualitative interviews.

Will be assessed via California Psychotherapy Alliance Scales (CALPAS, Marmar \& Gaston, 1989) for patients and therapists.

Will be assessed via inventory for assessment of interpersonal problems (IIP-D-32, Thomas, Brähler \& Strauß, 2011).

Will be assessed via Helping Alliance Questionnaire (HAQ, Luborsky et al., 1996) (IIP-D-32, Thomas, Brähler \& Strauß, 2011) for patients and therapists.

Universitätsklinikum Hamburg-Eppendorf

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

Adult informal caregivers of patients who are diagnosed with stage IV solid tumors or stage III lung or ovarian tumors

In this longitudinal cohort study, patients and caregivers will not receive an intervention. In addition to the outcomes named in the section "Outcome Measures" patients and caregivers will complete self-report questionnaires for

Existential distress (Demoralization Scale-II, Death and Dying Distress Scale, Depressive Experiences Questionnaire, Revised Loss Orientation and Life Engagement in Advanced Cancer Scale, Sense of Dignity Item, Patient Dignity Inventory, Marwit-Meuser Caregiver Grief Inventory, Caregiver Guilt Questionnaire)

Need for and utilization of psychosocial support

Resources (Sources of Meaning and Meaning in Life Questionnaire, Questionnaire on the Defiant Power of the Human Spirit) and

Control variables (Memorial Symptom Assessment Scale, PHQ-9 and GAD-7)

Self-report questionnaires

Sigrun Vehling, PhD

Despite the potential for alleviation of existential distress through psychosocial interventions, existential concerns and their impact on health care outcomes of patients and caregivers have not yet been systematically studied. The aim of this longitudinal cohort study is to investigate the frequency, longitudinal trajectory and predictive impact of existential distress on patient- and caregiver-relevant end-of-life outcomes. Further, it aims to determine the need for and utilization of psychosocial support in patients and caregivers with regard to existential concerns.

Due to medical progress and an aging population, the number of patients and caregivers who face the profound existential challenges of advanced incurable cancer is constantly growing. Clinically significant existential distress may result from a fear of suffering and perceived lack of control, fear and uncertainty about the end of life, feelings of burdensomeness or insufficiency, grief about missed opportunities, and profound loneliness. Such distress may have a unique and independent contribution to health care outcomes at the end of life. Despite an increasing interest in existential and palliative care interventions that discuss such issues openly, a lack of systematic quantitative data on existential distress and specific support needs hampers clinicians to consequently detect and address existential needs. This longitudinal study aims to 1) systematically investigate the frequency, longitudinal trajectory and predictive impact of existential distress on patient- and caregiver-relevant end-of-life outcomes and 2) determine patients' and caregivers' specific need for and utilization of psychosocial support with respect to existential concerns.

Adult patients diagnosed with advanced cancer and caregivers will be consecutively recruited from outpatient and inpatient treatment facilities of the Univer-sity Cancer Center Hamburg and affiliated clinics. Existential distress, end-of-life outcomes, and mental disorders in 1,000 participants (500 patients, 500 care-givers) will be assessed using self-report questionnaires at five points of assessment over a period of 12 months and diagnostic interviews (at baseline, after six months). To determine the prevalence of existential distress, mental disorders and palliative care outcomes descriptive statistics will be calculated. Descriptive analyses will also be used to examine the need for and utilization of psychosocial support. To investigate the predictive impact of existential distress and patient- and caregiver-relevant end-of-life outcomes multiple linear and logistic regression will be conducted. To analyze longitudinal trajectory of existential distress growth mixture models will be used.

Shaping a clear and systematic knowledge about frequent and persistent existential concerns that are most relevant to the risk for unfavorable end-of-life outcomes, results will significantly contribute to the recognition and manage-ment of existential distress and provide a valuable basis for the development of targeted interventions.

Existential Distress in Patients With Advanced Cancer and Their Caregivers

Existential Distress in Patients With Advanced Cancer and Their Caregivers: A Longitudinal Cohort Study

Will be assessed for patients 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.

Will be assessed for patients and caregivers using the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (SCID-5, Beesdo-Baum et al., 2019).

Will be assessed according to International Classification of Diseases (ICD-11) for patients and caregivers using the Adjustment Disorder Module of the CIDI (Composite International Diagnostic Interview, (Perkonigg et al., 2018).

Will be assessed for patients and caregivers using the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (SCID-5, Beesdo-Baum et al., 2019).

Will only be assessed for patients and caregivers who were recruited at location no.4 (Specialized Outpatient Clinic for Autoimmune Liver Disease and for Liver and Bile Duct Tumors, University Medical Center Hamburg-Eppendorf).

Will be assessed for patients using the short form of the Schedule of Attitudes Toward Hastened Death (SAHD-A, Kolva et al., 2017). Items are scored with either being true (1) or false (0). The total score is the number of endorsed items, ranging from 0 to 6, with high scores indicating high levels of desire for hastened death.

Will be assessed for patients and caregivers using the Beck Scale for Suicidal Ideation (BSS, Kliem \& Brähler, 2015). Items are scored from 0 to 2 (e.g., 0 = I have a moderate to strong wish to live, 1 = I have a weak wish to live, 2 = I have no wish to live). The sum score ranges from 0 to 38 for the total scale, with higher scores indicating stronger suicidal tendencies.

Will be assessed for patients and caregivers using the Structured Interview for Psychological Adjustment and Demoralisation (Bobevski \& Kissane, 2019). Participants may answer most of the questions with yes or no.

Will be assessed for caregivers after the patient's death using the Inventory of Complicated Grief (ICG; Lumbeck et al., 2012). Items are scored from 0 (never) to 4 (always). The sum score ranges from 0 to 76, with scores ≥ 25 indicating experiences of complicated grief.

Will be assessed from the caregivers' perspective using a shot version of the Quality of Dying and Death Questionnaire (QODD, Mah et al., 2020). Caregivers indicate how they would rate each experience for the patient on a scale from 0 (terrible experience) to 10 (almost perfect experience). The total score ranges between 0 and 100, with higher scores indicating a better quality of the dying experience.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Short-term Psychodynamic Psychotherapy in Serious Physical Illness	NCT05520281	Malignant Neopl... Carcinoma Palliative Care	Short-term psyc...	18 Years -	Universitätsklinikum Hamburg-Eppendorf
Existential Distress in Patients With Advanced Cancer and Their Caregivers	NCT04600206	Neoplasms Malig... Carcinoma Palliative Care	Self-report que...	18 Years -	Universitätsklinikum Hamburg-Eppendorf
Existential Distress in Patients With Advanced Cancer and Their Caregivers	NCT04600206	Neoplasms Malig... Carcinoma Palliative Care	Self-report que...	18 Years -	Universitätsklinikum Hamburg-Eppendorf
Short-term Psychodynamic Psychotherapy in Serious Physical Illness	NCT05520281	Malignant Neopl... Carcinoma Palliative Care	Short-term psyc...	18 Years -	Universitätsklinikum Hamburg-Eppendorf

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