Existential Distress in Patients with Advanced Cancer and Their Caregivers

NCT04600206 | Completed

• 1 other identifier: DKH70113404
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Neoplasms Malignant; Carcinoma; Palliative Care

Keywords

Advanced cancer; Caregivers; Death anxiety; Demoralization; Existential distress; Longitudinal studies; Mental disorders

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (5)

• Desire for hastened death

  6- and 12-months-follow-up

• Suicidal ideation

  6- and 12-months-follow-up

• Coping and Demoralization

  6-months follow-up

• Complicated grief

  3 months post-death

• Quality of dying and death

  3 months post-death

Study Arms (2)

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

Other: Self-report questionnaires

Caregivers

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

Other: Self-report questionnaires

Interventions

Self-report questionnaires OTHER

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; Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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

You may qualify if:

• years and older
• UICC stage IV solid tumor or UICC stage III lung or ovarian tumor
• Informed consent

You may not qualify if:

• Severe cognitive
• Severe physical impairment
• Insufficient German to give informed consent and complete self-report questionnaires

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (5)

Center for Oncology, University Medical Center Hamburg-Eppendorf

Hamburg, Germany, 20246, Germany

Location

Albertinen Krankenhaus

Hamburg, Germany, 22457, Germany

Location

LungenClinic Grosshansdorf

Hamburg, Hamburg, 22927, Germany

Location

Gynecological Outpatient Clinic, University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Specialized Outpatient Clinic for Autoimmune Liver Disease and for Liver and Bile Duct Tumors, University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Related Publications (1)

• Philipp R, Kalender A, Harter M, Bokemeyer C, Oechsle K, Koch U, Vehling S. Existential distress in patients with advanced cancer and their caregivers: study protocol of a longitudinal cohort study. BMJ Open. 2021 Apr 24;11(4):e046351. doi: 10.1136/bmjopen-2020-046351.

  PMID: 33895716 DERIVED

MeSH Terms

Conditions

Neoplasms; Carcinoma; Necrophobia; Mental Disorders

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Sigrun Vehling, PhD

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2020
• First Posted: October 23, 2020
• Study Start: October 23, 2020
• Primary Completion: December 8, 2024
• Study Completion: December 8, 2024
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (5)