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Neoplasms MalignantNCT04600206

Existential Distress in Patients with Advanced Cancer and Their Caregivers

An observational study of Neoplasms Malignant and Carcinoma, run by Universitätsklinikum Hamburg-Eppendorf at 5 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neoplasms Malignant, Carcinoma, Palliative Care
What is being tested?
Self-report questionnaires
Type of treatment
Injection or infusion
How many people
800 participants
Where
5 sitesGermany
Study dates
23 Oct 2020to 8 Dec 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Germany5 sites

  • LungenClinic Grosshansdorf

    Hamburg, Free and Hanseatic City of Hamburg, 22927

  • Center for Oncology, University Medical Center Hamburg-Eppendorf

    Hamburg, Germany, 20246

  • Albertinen Krankenhaus

    Hamburg, Germany, 22457

  • Gynecological Outpatient Clinic, University Medical Center Hamburg-Eppendorf

    Hamburg, 20246

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

    Hamburg, 20246

Other trials in Germany

About this study

Official title: Existential Distress in Patients with Advanced Cancer and Their Caregivers: a Longitudinal Cohort Study

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.

Read the 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.

Being tested
Self-report questionnaires
Keywords
Advanced cancer, Caregivers, Death anxiety, Demoralization, Existential distress, Longitudinal studies, Mental disorders
Medical subject headings
Neoplasms, Carcinoma, Necrophobia, Mental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Self-report questionnairesOther

    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)

Study groups in NCT04600206
Study groupRoleWhat they receive
PatientsAdult patients across all phases of advanced disease (UICC stage IV solid tumor or stage III lung or ovarian tumor) from diagnosis to terminal stages
Receives: Other: Self-report questionnaires
CaregiversAdult informal caregivers of patients who are diagnosed with stage IV solid tumors or stage III lung or ovarian tumors
Receives: Other: Self-report questionnaires

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 4 weeks prior to death

  2. 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).

    Measured: 6-months follow-up

  3. 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).

    Measured: 6-months follow-up

  4. 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).

    Measured: 6-months follow-up

Secondary outcomes (5)

  1. 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.

    Measured: 6- and 12-months-follow-up

  2. 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.

    Measured: 6- and 12-months-follow-up

  3. 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.

    Measured: 6-months follow-up

  4. 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.

    Measured: 3 months post-death

  5. 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.

    Measured: 3 months post-death

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2020
  2. Study start23 Oct 2020
  3. Primary completion8 Dec 2024
  4. Study completion8 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
800 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04600206
Sponsor's protocol ID
DKH70113404
Status last verified
Mar 2025
First submitted
29 Aug 2020
Last updated
30 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Walbaum C, Philipp R, Bokemeyer C, Harter M, Junghans J, Koch U, Oechsle K, Schilling G, Vehling S. Death Anxiety in Patients With Advanced Cancer and Their Family Caregivers. J Pain Symptom Manage. 2024 Dec;68(6):622-631. doi: 10.1016/j.jpainsymman.2024.08.027. Epub 2024 Aug 29.

    PubMed 39182590

  • 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.

    PubMed 33895716

Questions about this trial

What is this clinical trial studying?

An observational study of Neoplasms Malignant and Carcinoma, run by Universitätsklinikum Hamburg-Eppendorf at 5 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Aggressiveness of care (time frame: 4 weeks prior to death). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04600206, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.

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