- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04600206
Existential Distress in Patients With Advanced Cancer and Their Caregivers
Existential Distress in Patients With Advanced Cancer and Their Caregivers: A Longitudinal Cohort Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Sigrun Vehling, PhD
- Phone Number: +4940741056805
- Email: s.vehling@uke.de
Study Contact Backup
- Name: Rebecca Philipp, MSc
- Phone Number: +4940741056203
- Email: r.philipp@uke.de
Study Locations
-
-
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Hamburg, Germany, 22457
- Albertinen Krankenhaus
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Hamburg, Germany, 20246
- Center for Oncology, University Medical Center Hamburg-Eppendorf
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Hamburg, Germany, 20246
- Gynecological Outpatient Clinic, University Medical Center Hamburg-Eppendorf
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Hamburg, Germany, 20246
- Specialized Outpatient Clinic for Autoimmune Liver Disease and for Liver and Bile Duct Tumors, University Medical Center Hamburg-Eppendorf
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Hamburg, Germany, 22927
- LungenClinic Grosshansdorf
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
- Patients across all phases of advanced disease from diagnosis to terminal stages who are treated in outpatient and inpatient treatment facilities of the University Cancer Center Hamburg and affiliated clinics
- Caregivers whose relatives are diagnosed with advanced cancer
Description
Inclusion Criteria:
- 18 years and older
- UICC stage IV solid tumor or UICC stage III lung or ovarian tumor
- Informed consent
Exclusion Criteria:
- Severe cognitive
- Severe physical impairment
- Insufficient German to give informed consent and complete self-report questionnaires
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients
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
|
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) |
Caregivers
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) |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Aggressiveness of care
Time Frame: 4 weeks prior to death
|
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.
|
4 weeks prior to death
|
Prevalence of affective and anxiety disorders
Time Frame: 6-months follow-up
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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).
|
6-months follow-up
|
Prevalence of adjustment disorder
Time Frame: 6-months follow-up
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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).
|
6-months follow-up
|
Prevalence of substance use disorders
Time Frame: 6-months follow-up
|
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). |
6-months follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Desire for hastened death
Time Frame: 6- and 12-months-follow-up
|
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.
|
6- and 12-months-follow-up
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Suicidal ideation
Time Frame: 6- and 12-months-follow-up
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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.
|
6- and 12-months-follow-up
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Coping and Demoralization
Time Frame: 6-months follow-up
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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.
|
6-months follow-up
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Complicated grief
Time Frame: 3 months post-death
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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.
|
3 months post-death
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Quality of dying and death
Time Frame: 3 months post-death
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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.
|
3 months post-death
|
Collaborators and Investigators
Investigators
- Principal Investigator: Sigrun Vehling, PhD, Universitätsklinikum Hamburg-Eppendorf
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DKH70113404
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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