Carcinoma Clinical Trial
Official title:
Existential Distress in Patients With Advanced Cancer and Their Caregivers: A Longitudinal Cohort Study
Verified date | August 2023 |
Source | Universitätsklinikum Hamburg-Eppendorf |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 800 |
Est. completion date | June 2024 |
Est. primary completion date | June 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 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Albertinen Krankenhaus | Hamburg | |
Germany | Center for Oncology, University Medical Center Hamburg-Eppendorf | Hamburg | |
Germany | Gynecological Outpatient Clinic, University Medical Center Hamburg-Eppendorf | Hamburg | |
Germany | LungenClinic Grosshansdorf | Hamburg | |
Germany | Specialized Outpatient Clinic for Autoimmune Liver Disease and for Liver and Bile Duct Tumors, University Medical Center Hamburg-Eppendorf | Hamburg |
Lead Sponsor | Collaborator |
---|---|
Universitätsklinikum Hamburg-Eppendorf |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Aggressiveness of care | 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 | |
Primary | Prevalence of affective and anxiety disorders | 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 | |
Primary | Prevalence of adjustment disorder | 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 | |
Primary | Prevalence of substance use disorders | 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 | Desire for hastened death | 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 | |
Secondary | Suicidal ideation | 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 | |
Secondary | Coping and Demoralization | 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 | |
Secondary | Complicated grief | 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 | |
Secondary | Quality of dying and death | 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 |
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