Behaviors and Mental Disorders

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Digestive System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Depressive Disorder

Schizophrenia

Mental Disorders

Breast Neoplasms

Depressive Disorder, Major

Depression

Head and Neck Neoplasms

Lung Neoplasms

Bipolar Disorder

Psychotic Disorders

Gastrointestinal Neoplasms

Digestive System Neoplasms

Urogenital Neoplasms

Behavioral Symptoms

Mood Disorders

Schizophrenia Spectrum and Other Psychotic Disorders

Bipolar and Related Disorders

Gastrointestinal Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

This intervention has three parts:

Part 1: Proactive identification and assessment of patient needs, values, psychiatric symptoms, and illness understanding

Part 2: Virtual tumor board discussion

o Bring together expertise in mental illness and cancer, the interdisciplinary team will co-design an integrated cancer and mental health treatment plan. Key strategies include: addressing resource-related barriers to care, framing next steps in terms of patient values, and identifying action steps to address barriers to psycho-oncology/specialty oncology expertise

Part 3: Closed Loop Communication

o Tumor board recommendations shared with treating oncologist, documented in medical record, and shared with patient. Team tracks steps taken to address barriers to care and follows up with patient at 12 weeks.

The Virtual Cancer and Mental Health Tumor Board intervention aims to increase access to psycho-oncology and oncology expertise, facilitate clinician communication, build understanding of the person's needs and strengths, and address barriers to care. Strategies include a proactive assessment of illness understanding, psychiatric history, and barriers to care followed by development of an integrated cancer and mental health treatment plan during the tumor board session that is framed in terms of patient values and addresses barriers to accessing psycho-oncology and specialty oncology expertise. These recommendations will be shared with treating oncologists, documented in the medical record, and shared with the patient. Patients will receive a transition phone call at 12 weeks.

Virtual Cancer and Mental Health Tumor Board

Kelly Irwin, MD, MPH

Elizabeth P Walsh, MD

This study examines the feasibility and acceptability of a virtual tumor board for cancer and mental illness for patients with serious mental illness and a new cancer diagnosis. The study also examines the impact on patient care, psychiatric symptoms, and clinician self-efficacy in managing this population.

Individuals with serious mental illness (SMI) experience increased cancer mortality because of inequities in cancer care. Access to mental health and cancer care remains inadequate. Virtual tumor boards have been associated with higher rates of patients receiving guideline-concordant cancer care, but these tumor boards have not been adapted for cancer and mental illness. A virtual cancer and mental health tumor board intervention has potential to increase access to psycho-oncology and oncology expertise, facilitate clinician communication, and may address barriers to cancer and mental health care. The purpose of this study is to examine the feasibility and acceptability of a virtual tumor board for cancer and mental illness for our target population for patients and clinicians. We will also explore changes in cancer care, psychiatric symptoms, and clinician self-efficacy in managing this population. This study is a single-arm pilot (n = 30) based at a cancer center affiliate and the surrounding community. The intervention includes proactive identification using a registry, bi-monthly virtual equity tumor board focused on cancer and mental health using HIPAA-compliant videoconference that uses co-learning, assessment of barriers to cancer care, strengths, and goals of care, creating plans that identify who is responsible for next steps and patient communication, and relaying recommendations to patients and the treating oncology team.

Adapting the Tumor Board Model for Mental Illness and Cancer

Adapting the Tumor Board Model for Mental Illness and Cancer: A Single Arm Pilot Trial

Investigators will assess change in patient psychiatric illness severity using the Brief Psychiatric Rating Scale (BPRS). This questionnaire is 24 items, each question rated on a 7-point scale of severity ranging from "not present" to "extremely severe." Scores vary from 24 to 168 with higher scores indicating more severe psychiatric illness.

Investigators will assess change in patient anxiety symptoms using the Generalized Anxiety Disorder-7 (GAD-7). This questionnaire is 7 items, and responses range from "0" (not at all) to "3" (nearly every day), and scores range from 0 to 21, with higher scores indicating greater anxiety.

Investigators will assess change in patient depression symptoms using the Patient Health Questionnaire-9 (PHQ-9). This questionnaire is 9 items, and responses range from "0" (not at all) to "3" (nearly every day), and scores range from 0 to 27, with higher scores indicating greater depression.

Investigators will assess change in patient quality of life using the Functional Assessment of Cancer Therapy - General (FACT-G). This questionnaire is 27 items, and response are on a 5-point rating scale from "0" (not at all) to "4" (very much). Scores range from 0 - 108, and higher scores indicate better quality of life.

Investigators will assess change in tumor board participant self-efficacy using the Tumor Board Participant Self-Efficacy Assessment. This questionnaire is 22 items, with scores ranging from 0 - 44, and higher scores indicating more self-efficacy.

Investigators will assess change in tumor board participant burnout using a modified Maslach Burnout Inventory survey. This questionnaire is 22 items, and responses range from "0" (never) to "6" (every day). Section A scores range from 0 - 42, with a higher score indicating more burnout. Section B scores range from 0 - 42, with a higher score indicating more burnout. Section C scores range from 0 - 48, with a higher score indicating less burnout.

Number of participants with Disruptions in patient cancer care assessed by electronic medical record review. Disruptions are defined as delays, deviations in cancer care recommended, and interruptions in planned cancer treatment.

Number of participants with documented receipt of mental health care for patients assessed by electronic medical record review.

The investigators will evaluate program feasibility through patient enrollment by examining consent rates (60% of eligible patients consent).

The investigators will evaluate trial completion assessed by number of patients who complete study assessments and trial procedures (75% of patient participants have baseline targeted assessment, have tumor board recommendations communicated with them, and complete 12-week assessment of psychiatric symptoms and barriers to cancer care).

The investigators will evaluate program acceptability through patient intervention satisfaction by a patient feedback questionnaire (exit interview surveys with participating patients regarding the usefulness of the intervention) at 12 weeks.

The investigators will evaluate program feasibility by tracking volume of tumor board session attendance (feasibility defined as participants attending 80% of sessions when patients/clients discussed).

The investigators will evaluate program acceptability by examining participant intervention satisfaction (feedback questionnaire at end of study period regarding the acceptability and helpfulness of the virtual tumor board model).

The investigators will evaluate program feasibility by examining the amount of multi-disciplinary representation at tumor board sessions (\>70% of sessions include representation from oncology/cancer center affiliate, community mental health, and psycho-oncology).

The investigators will evaluate program feasibility by tracking percentage of tumor board participants participating in tumor board sessions (80% of participants complete intra-session feedback questionnaire).

The investigators will evaluate program feasibility by examining completion of study measures (70% of participants complete 12-week- and 24-week measures).

The investigators will evaluate program acceptability by examining participant intervention satisfaction (in-session feedback questionnaire regarding the acceptability and helpfulness of the virtual tumor board model).

Trefler Foundation

Massachusetts General Hospital

Principal Investigator

Symptoms and General Pathology

Carcinoma

Anxiety Disorders

Death

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

Nervous System Diseases

Rare Diseases

Inflammation

Dementia

Alzheimer Disease

Cognitive Dysfunction

Necrosis

Brain Diseases

Central Nervous System Diseases

Neurodegenerative Diseases

Tauopathies

Neurocognitive Disorders

Cognition Disorders

Familial Alzheimer Disease

1.0 mg/kg XPro1595 will be administered via subcutaneous injection once a week for 12 weeks.

1.0 mg/kg of Placebo will be administered via subcutaneous injection once a week for 12 weeks.

XPro1595 will be delivered by subcutaneous injection once a week.

XPro1595

Placebo will be delivered by subcutaneous injection once a week

Placebo

Tara Lehner

The goal of this Phase 2 MCI study is to determine whether 1.0 mg/kg XPro1595 is superior to placebo at improving measures of cognition, functioning and brain quality in individuals with MCI and biomarkers associated with neuroinflammation (APOE4) and to evaluate safety, tolerability, and efficacy of XPro1595.

This study is designed as a Phase 2, double-blind randomized, placebo-controlled study investigating the safety, tolerability, and efficacy of XPro1595 in patients with MCI. The planned dose is 1.0 mg/kg of XPro1595 and matching placebo.

* (2:1) XPro1595 (1mg/kg), placebo
* Weekly subcutaneous injections

Study to Assess the Efficacy of XPro1595 in Patients With Mild Cognitive Impairment With Biomarkers of Inflammation

A Phase 2, Randomized, Placebo-Controlled, Double-Blind Study of XPro1595 in Patients With Mild Cognitive Impairment (MCI) With Biomarkers of Inflammation

Change in Goal Attainment Scale (GAS)

The achievement of each goal is rated on a 5-point attainment scale (-2, -1, 0, +1, +2) to allow standardized scoring of personalized outcomes. A participant's overall goal attainment is quantified using a formula that takes into account the number of goals that have been set, and the extent to which they are correlated with each other. For each identified goal area, the caregiver will be asked to give a detailed description of the patient's current (baseline) status and goal status, which will be recorded at the -1 and 0 levels on the 5-point scale, respectively. The remaining levels of the scale will then be set: somewhat better than the goal (+1), much better than the goal (+2), and much worse than the goal (-2).

To evaluate the effect of XPro1595 compared with placebo on goal attainment scores

Change from Screening to Week 12 in activity metrics (time spent lying, sitting, standing, stepping, upright, in walking bouts, in-context specific walking bouts; number of steps, and sit-to-stand transitions) as measured by the activity monitor. Physical activity will be measured in real time using the activity monitor worn on the patient's wrist. Total activity counts per minute (higher activity counts = more activity) and number of steps taken will be derived from data. Patients will be equipped with the monitoring device during the screening period and activity metrics will be measured for 7 days prior to each EMACC assessment. Data will be measured at Screening, Week 1, Week 3, Week 6, Week 9 and Week 12.

To assess the effect of XPro1595 compared to placebo on measures of activity

The Multidimensional Psychological Questionnaire (MPsQ) questionnaires have been designed to specifically measure patient personality characteristics associated with the placebo response. The MPsQ questionnaires are self-reported, and each item is rated on a 5-point scale ranging from 1 (strongly disagree) to 5 (strongly agree).

MPsQs will be completed by the patient and separate MPsQs will be completed by the study partner at screening.

MPsQs will be completed by the patient and separate MPsQs will be completed by the study partner prior to investigational product administration.

The patient and study partner will complete MPsQs at Screening and Week 1.

To measure patient personality characteristics associated with the placebo response.

Change from Baseline to Week 12 in the Early and Mild Alzheimer's Cognitive Composite (EMACC) (Jaeger 2017) made up of the following tests:

* International Shopping List Test- Immediate recall (Word List Learning Test-Immediate recall)
* Trail Making Test Part A and B
* Digit Symbol Coding Test
* Digit Span Forward and Backward
* Category Fluency Test (DKEFS)
* Letter Fluency Test (DKEFS)

To assess the efficacy of XPro1595 compared with placebo on cognitive performance in patients with MCI

Change from Screening to Week 12 in Cogstate Composite mean score.

Cogstate is a brief, computerized, neuropsychological battery to evaluate cognitive impairments in mild cognitive impairment (MCI), and Alzheimer's disease (AD). CogState assesses attention and memory functions - including Information processing speed, Visual attention, Working memory and Visual learning. Cogstate scores are measured on a linear scale (with no maximum score). A reduction in scores compared to baseline signifies an improvement in cognitive functions.

The Cogstate battery will be administered at Screening and each week for 12 weeks.

To assess the efficacy of XPro1595 compared with placebo on cognitive performance in patients with MCI

Change from Screening to Week 12 in myelin content.

Change from Screening to Week 12 in blood inflammatory and neurodegeneration biomarkers (on blood inflammatory and neurodegeneration biomarker amyloid)

To assess the efficacy of XPro1595 compared with placebo on blood inflammatory and neurodegeneration biomarkers (on blood inflammatory and neurodegeneration biomarker amyloid)

Change from Screening to Week 12 in blood inflammatory and neurodegeneration biomarkers (on blood inflammatory and neurodegeneration biomarker pTau)

To assess the efficacy of XPro1595 compared with placebo on blood inflammatory and neurodegeneration biomarkers (on blood inflammatory and neurodegeneration biomarker pTau)

Change from Screening to Week 12 in MRI neuroinflammation (White matter Free Water)

To assess the efficacy of XPro1595 compared with placebo on imaging neuroinflammation

Change from Screening to Week 12 in regional brain glucose uptake as measured by F-fluorodeoxyglucose-Positron Emission Tomography (FDG-PET) scans

Alzheimer's Disease (AD) is characterized by a chronic brain glucose deficit. White matter glucose deterioration is also evident in Mild Cognitive Impairment (MCI) and specific to limbic fascicles. We will quantify the change in regional brain glucose uptake for gray matter and white matter tracts using PET imaging and the F-fluorodeoxyglucose (FDG) radiotracer. PET maps will be registered to Magnetic Resonance (MR) anatomical images and corrected for partial volume effect. Standard uptake value ratios (SUVr) will be calculated using the cerebellum as a reference region.

FDG-PET scans will be performed at Screening and Week 12.

To assess the efficacy of XPro1595 compared with placebo on imaging markers of brain quality

Change from Baseline to Week 12 in MRI Apparent Fiber Density (AFD)

To assess the efficacy of XPro1595 compared with placebo on axonal integrity in patients with MCI

Change from Screening to Week 12 in Neuropsychiatric Inventory (NPI-12) study partner items

To assess the effect of XPro1595 compared with placebo on non-cognitive behavioral symptoms in patients with MCI

Change from Screening to Week 12 in brain activity as measured by electroencephalogram (EEG) scans (Change in brain activity as measured by the EEG in microvolts).

Specifically, a series of EEG markers previously associated with AD (Horvath et al. 2018) including high and low frequency band powers, the P300, and Mismatch Negativity (MMN) event-related potentials will be evaluated.

An EEG scan will be administered at Screening and each week for 12 weeks.

To assess the efficacy of XPro1595 compared with placebo on brain activity in patients with MCI

Change from Baseline to Week 12 in language and speech patterns using Winterlight Labs analysis

To assess the effect of XPro1595 compared with placebo on speech and language in patients with MCI

Change from Screening to Week 12 in Alzheimer's Disease Cooperative Study - Mild Cognitive Impairment Activities of Daily Living (ADCS-MCI ADL)

The 23-item ADCS-MCI-ADL Scale has good test-retest reliability, will be utilized to assess performance functioning in MCI patients (Galasko et al., 1997; Douglas Galasko et al., 2006; Pedrosa et al., 2010). The ADCS-ADL includes 18 items from traditional basic ADL scales and 5 items from instrumental activities of daily living scales (IADL) The possible range of total scores for the ADL Scale is 0-53 and higher scores indicate better functioning. The internal reliability was .91( Galasko et al., 1997; Douglas Galasko et al., 2006; Pedrosa et al., 2010).

The ADCS-MCI ADL will be performed at Screening and Week 12.

To assess the effect of XPro1595 compared with placebo on Activities of Daily Living (ADL) in patients with MCI

Change from Screening to Week 12 in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB)

The CDR scale is a clinician-rated dementia staging system that tracks the progression of cognitive impairment in 6 categories (memory, orientation, judgement and problem solving, community affairs, home and hobbies, and personal care). Each category is scored on a 5-point scale in which None = 0, Questionable = 0.5, Mild = 1, Moderate = 2, and Severe = 3. The global CDR score is established by clinical scoring rules and has values of 0 (no dementia), 0.5, (questionable dementia), 1 (mild dementia), 2 (moderate dementia), and 3 (severe dementia). The Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) is obtained by adding the ratings in each of the 6 categories and ranges from 0 to 18 with higher scores indicative of greater impairment.

To assess the effect of XPro1595 compared with placebo on cognition and global function in patients with MCI

Clinically significant abnormalities of laboratory values, physical findings, electrocardiogram findings and other safety assessments will be recorded as adverse events if the findings meet the defined criteria for adverse events.

Inmune Bio, Inc.

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.

Anja Mehnert-Theuerkauf, Prof

The primary objectives of this prospective observational multicenter study LUPE are to assess the prevalence of mental disorders according to the DSM-5 (objective need for psycho-oncological support), psychosocial distress, psycho-oncological care needs and utilization of psycho-oncological support services (subjective need for support) of cancer patients and their relatives during the first months of cancer survivorship stratified by biopsychosocial factors including socioeconomic status. The investigators further aim to identify moderating and mediating as well as associated factors for psychological distress and supportive care needs.

LUPE will include 2000 adult patients with solid tumor entities and one relative per patient at 4 measurement points from time of diagnosis to follow-up (+18 months) (t1: after diagnosis, t2: 6 month later, t3: 6 month later, t4: 6 month later).

The investigators aim to generate a quota sample according to socioeconomic status (SES) that is representative of the German overall population.

All participants will receive validated self-report questionnaires. Cancer patients will be interviewed using the standardized clinical interview SCID-5.

Longitudinal Analysis of Mental Disorders, Psychosocial Distress and Care Needs of Patients and Their Relatives

Longitudinal Analysis of Mental Disorders, Psychosocial Distress and Psycho-oncological Care Needs of Patients and Their Relatives Stratified by Biopsychosocial Factors (LUPE)

PHQ (Patient Health Questionnaire - Depression)

EORTC (European Organisation for Research and Treatment of Cancer - Quality of life)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Adapting the Tumor Board Model for Mental Illness and Cancer	NCT05837598	Cancer Severe Major De... Schizophrenia Bipolar Disorde... Lung Cancer Breast Cancer Head and Neck C... Gastrointestina... Genitourinary C...	Virtual Cancer ...	18 Years -	Massachusetts General Hospital
Short-term Psychodynamic Psychotherapy in Serious Physical Illness	NCT05520281	Malignant Neopl... Carcinoma Palliative Care	Short-term psyc...	18 Years -	Universitätsklinikum Hamburg-Eppendorf
Study to Assess the Efficacy of XPro1595 in Patients With Mild Cognitive Impairment With Biomarkers of Inflammation	NCT05321498	Mild Cognitive ... Alzheimer Disea... Dementia Brain Diseases Central Nervous... Nervous System ... Tauopathies Neurodegenerati... Mental Disorder...	XPro1595 Placebo	55 Years - 80 Years	Inmune Bio, Inc.
Existential Distress in Patients With Advanced Cancer and Their Caregivers	NCT04600206	Neoplasms Malig... Carcinoma Palliative Care	Self-report que...	18 Years -	Universitätsklinikum Hamburg-Eppendorf
Longitudinal Analysis of Mental Disorders, Psychosocial Distress and Care Needs of Patients and Their Relatives	NCT04620564	Neoplasm Malign...		18 Years -	University of Leipzig
Study to Assess the Efficacy of XPro1595 in Patients With Mild Cognitive Impairment With Biomarkers of Inflammation	NCT05321498	Mild Cognitive ... Alzheimer Disea... Dementia Brain Diseases Central Nervous... Nervous System ... Tauopathies Neurodegenerati... Mental Disorder...	XPro1595 Placebo	55 Years - 80 Years	Inmune Bio, Inc.
Longitudinal Analysis of Mental Disorders, Psychosocial Distress and Care Needs of Patients and Their Relatives	NCT04620564	Neoplasm Malign...		18 Years -	University of Leipzig
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

Spots Global Cancer Trial Database for mental disorders