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Caregiver BurdenNCT05867706

Caregiver Stress and Bereavement

An observational study of Caregiver Burden and Bereavement, run by University of Zurich at 1 site in Switzerland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The death of a spouse is considered one of the most stressful and impactful life events and is associated with increased morbidity and premature mortality. Early identification of individuals who are most at risk for poor health outcomes following bereavement is an important aim of precision medicine and disease… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Caregiver Burden, Bereavement, Cancer
How many people
150 participants
Where
1 siteSwitzerland
Study dates
1 Oct 2024to 31 Dec 2027
Phase
Observational
Are there results?
Not yet: the study is under way

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
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Spouses or caregivers (N = 100) of patients suffering from an advanced cancer that is unlikely to be cured or controlled with treatment and is likely to cause death (estimated life expectancy of ≤ 6 months). Spouses/caregivers of severely ill cancer patients will be assigned to the study and followed for a period of one year. In addition, fifty gender and age-matched non-bereaved subjects will be recruited in the community. However, this control group will undergo only one assessment.

Who may be able to join

  • Participant age ≥ 18 years
  • Caregiver or spouse of a patients suffering from a terminal illness (estimated life expectancy ≤ 6 months),
  • regarded as the patients primary caregiver (i.e., intimately involved in care of the patient since time of the diagnosis, looking after his/her daily needs, supervising the medications, bringing the patient to the hospital, staying with the patient during inpatient stay, and maintaining liaison with the hospital staff),
  • German as primary language
  • signed informed consent.

Who cannot join

  • Significant visual or auditory problems, cognitive impairment,
  • morbid obesity (body mass index ≥40 kg/m2,
  • alcohol or drug abuse
  • active malignancy
  • severe illness (respiratory, heart, liver and renal failure)
  • major medical conditions involving the immune system (e.g., diabetes type 1 or 2, autoimmune and/ or inflammatory diseases including rheumatoid arthritis and ulcerative colitis, asthma, thyroid diseases)
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  • severe hypertension (>200/120 mmHg)
  • regular use of medication with major immunological consequences (e.g., corticosteroids, immunosuppressive therapy)
  • pregnant or breast-feeding

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Annina Seiler, PD PhD contact

+41 43 253 04 02

annina.seiler@usz.ch

Switzerland1 site, 1 recruiting
  • University Hospital Zurich

    Zurich, Canton of Zurich, 8091

    Annina Seiler, 0041 44 255 9739, annina.seiler@usz.ch

    Annina Seiler

    Recruiting

Other trials in Switzerland

About this study

Official title: The Psychobiological Adjustment to Bereavement Among Cancer Caregivers

The death of a spouse is considered one of the most stressful and impactful life events and is associated with increased morbidity and premature mortality. Early identification of individuals who are most at risk for poor health outcomes following bereavement is an important aim of precision medicine and disease prevention initiatives. A better understanding of caregiver burden and bereavement-related distress and its implication for health is a clinically-relevant step toward the development of treatments that improve health outcomes in bereaved spouses. This study aims to map profiles of individual differences in short- and long-term adjustment to loss, according to psychological (e.g., depression, stress, grief severity) and biological markers (e.g., inflammation, cortisol) over time.

Read the detailed description

The loss of a spouse is a highly impactful life event that places individuals at risk for mental and physical health problems. Particularly in the immediate weeks and months after the loss, bereavement is associated with a significantly increased risk of multimorbidity and mortality, including elevated inflammation, cardiovascular diseases and some cancers. Grief is a typical reaction to the loss of a significant person and is characterized by symptoms of intense distress, anxiety, yearning, longing, and sadness, all of which generally subside over time. There is considerable variability in how people respond to bereavement. Although the vast majority of bereaved individuals show resilience against loss and adjust adequately without professional psychological support, 10% - 20% of bereaved individuals develop intense and prolonged grief reactions.

The field of psychoneuroimmunology has contributed considerably to our understanding of the effect of stress on the psyche, as well as on the nervous, immune, and endocrine systems. Stressful life events, and the negative emotions they provoke, can induce low-grade inflammation through several autonomic, neuroendocrine, and neuroimmune pathways, which in turn suppress the effectiveness of the immune system, and thereby, increase vulnerability to physical and mental health problems across a person's lifespan. Bereavement is a highly-stressful event, which triggers biological responses via several autonomic, endocrine, and inflammatory mechanisms. Growing evidence suggests that the health consequences of caregiving for terminally-ill patients and bereavement after the loss of a spouse are associated with a wide spectrum of neuroendocrine factors and immunologic and inflammatory markers. Low-grade systemic inflammation, as reflected by elevated concentrations of cytokines (e.g., C-reactive protein, CRP; interleukin 6, IL-6; tumor necrosis factor alpha, TNF-a) is a robust risk factor for the onset of many diseases, including major depression, cardiovascular disease, and stroke.

The caregivers' burden and needs are often not a hospital's priority and overlooked. Yet, the health consequences of caring for a terminally-ill spouse, as well as the need for follow-up care programs for caregivers of a deceased spouse are not well understood. Acknowledging that bereavement-related changes in immune function could account considerably for an increased risk of morbidity and mortality in bereaved individuals, the identification of biobehavioral mechanisms that can be modified or targeted early is an important and clinically-relevant step toward the development of treatments that improve health outcomes in bereaved individuals.

The proposed study is based on the Social Signal Transduction Theory of Depression (Slavich et al.), which suggests that early life stress exposure can shape an individual's neuro-inflammatory sensitivity to stress to later- occurring threats or acute adverse life events, and thereby increase their vulnerability to physical and mental health problems across the lifespan.

The study's aims are two-fold: 1) to map profiles of individual differences in long-term adjustment to loss, according to psychological and biological markers over time; and 2) to examine whether cumulative lifetime stress exposure and neuro-inflammatory sensitivity to stress moderate the association between an acute stressful life event (i.e., the loss of a terminally-ill spouse after a long period of intensive caregiving) and the spouse's health outcomes following bereavement and, thereby, explain individual differences in resilience.

Keywords
caregiver, bereavement, stress, biomarkers, cancer, palliative care
Medical subject headings
Caregiver Burden, Neoplasms

What is being measured

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

  1. The Center for Epidemiological Studies Depression Scale (CES-D)

    Depression

    Measured: Assessment 1: 6 months before patient's death; Assessment: 3-6 months post-loss; Assessment: 9-12 months post-loss

  2. interleukine-6 (IL-6)

    Measure of inflammation

    Measured: Assessment 1: 6 months before patient's death; Assessment: 3-6 months post-loss; Assessment: 9-12 months post-loss

Secondary outcomes (15)
  1. The Stress and Adversity Inventory (STRAIN)

    Adverse life experiences

    Measured: Assessment 1: 6 months before patient's death

  2. Physical Health Questionnaire (PHQ-D)

    Physical Health

    Measured: Assessment 1: 6 months before patient's death; Assessment: 3-6 months post-loss; Assessment: 9-12 months post-loss

  3. Charlson Comorbidity Index (CC)

    Comorbidities

    Measured: Assessment 1: 6 months before patient's death; Assessment: 3-6 months post-loss; Assessment: 9-12 months post-loss

  4. The Perceived Stress Scale (PSS)

    Stress

    Measured: Assessment 1: 6 months before patient's death; Assessment: 3-6 months post-loss; Assessment: 9-12 months post-loss

  5. The RAND 12-Item Short Form Health Survey (SF-12)

    Quality of Life

    Measured: Assessment 1: 6 months before patient's death; Assessment: 3-6 months post-loss; Assessment: 9-12 months post-loss

  6. Pittsburg Sleep Quality Index (PSQI)

    Sleep quality

    Measured: Assessment 1: 6 months before patient's death; Assessment: 3-6 months post-loss; Assessment: 9-12 months post-loss

  7. PTSD Checklist for DSM-5 (PCL-5)

    PTSD symptoms

    Measured: Assessment 1: 6 months before patient's death; Assessment: 3-6 months post-loss; Assessment: 9-12 months post-loss

  8. Dissociative Subtype of PTSD Scale (DSPS)

    Dissociative symptomes

    Measured: Assessment 1: 6 months before patient's death; Assessment: 3-6 months post-loss; Assessment: 9-12 months post-loss

  9. Cognitive Processing Questionnaire (CPQ)

    Cognitive Processing

    Measured: Assessment 1: 6 months before patient's death; Assessment: 3-6 months post-loss; Assessment: 9-12 months post-loss

  10. The Inventory of Complicated Grief (ICG)

    Complicated grief

    Measured: Assessment 1: 6 months before patient's death; Assessment: 3-6 months post-loss; Assessment: 9-12 months post-loss

  11. Prolonged Grief Reaction (PG13+9)

    Prolonged grief

    Measured: Assessment 1: 6 months before patient's death; Assessment: 3-6 months post-loss; Assessment: 9-12 months post-loss

  12. heart-rate/heart-rate variability

    physiological stress marker

    Measured: Assessment 1: 6 months before patient's death; Assessment: 3-6 months post-loss; Assessment: 9-12 months post-loss

  13. nail cortisol and cortisone

    nail cortisol and cortisone

    Measured: Assessment 1: 6 months before patient's death; Assessment: 3-6 months post-loss; Assessment: 9-12 months post-loss

  14. tumor necrosis factor alpha (TNF-a)

    measure of inflammation

    Measured: Assessment 1: 6 months before patient's death; Assessment: 3-6 months post-loss; Assessment: 9-12 months post-loss

  15. C-reactive protein (CRP)

    measure of inflammation

    Measured: Assessment 1: 6 months before patient's death; Assessment: 3-6 months post-loss; Assessment: 9-12 months post-loss

Timeline

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

  1. First posted22 May 2023
  2. Study start1 Oct 2024
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

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
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05867706
Sponsor's protocol ID
KLS-5643-08-2022
Status last verified
Apr 2025
First submitted
9 Mar 2023
Last updated
4 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Caregiver Burden and Bereavement, run by University of Zurich at 1 site in Switzerland.

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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Annina Seiler, PD PhD (+41 43 253 04 02, annina.seiler@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Center for Epidemiological Studies Depression Scale (CES-D) (time frame: Assessment 1: 6 months before patient's death; Assessment: 3-6 months post-loss; Assessment: 9-12 months post-loss). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 4 Apr 2025.

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