Caregiver BurdenNCT05867706
Caregiver Stress and Bereavement
An observational study of Caregiver Burden and Bereavement, run by University of Zurich at 1 site in Switzerland.
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)
Show all 9Show fewer
- 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.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich
Zurich, Canton of Zurich, 8091
Annina Seiler, 0041 44 255 9739, annina.seiler@usz.ch
Annina Seiler
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.
- Conditions
- Caregiver Burden, Bereavement, Cancer
- 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.
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
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)
The Stress and Adversity Inventory (STRAIN)
Adverse life experiences
Measured: Assessment 1: 6 months before patient's death
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted22 May 2023
- Study start1 Oct 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregiver BurdenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- University of Salzburg, University of California
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Psychobiological Adjustment to Bereavement Among Cancer Caregivers
- ClinicalTrials.gov ID
- NCT05867706
- Acronym / sponsor ID
- KLS-5643-08-2022
- Conditions
- Caregiver Burden, Bereavement, Cancer
- Keywords
- caregiver, bereavement, stress, biomarkers, cancer, palliative care
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- University of Salzburg, University of California
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Depression
interleukine-6 (IL-6)
Time frame: Assessment 1: 6 months before patient's death; Assessment: 3-6 months post-loss; Assessment: 9-12 months post-loss
Measure of inflammation
15 secondary outcomes
The Stress and Adversity Inventory (STRAIN)
Time frame: Assessment 1: 6 months before patient's death
Physical Health Questionnaire (PHQ-D)
Time frame: Assessment 1: 6 months before patient's death; Assessment: 3-6 months post-loss; Assessment: 9-12 months post-loss
Charlson Comorbidity Index (CC)
Time frame: Assessment 1: 6 months before patient's death; Assessment: 3-6 months post-loss; Assessment: 9-12 months post-loss
The Perceived Stress Scale (PSS)
Time frame: Assessment 1: 6 months before patient's death; Assessment: 3-6 months post-loss; Assessment: 9-12 months post-loss
The RAND 12-Item Short Form Health Survey (SF-12)
Time frame: Assessment 1: 6 months before patient's death; Assessment: 3-6 months post-loss; Assessment: 9-12 months post-loss
Pittsburg Sleep Quality Index (PSQI)
Time frame: Assessment 1: 6 months before patient's death; Assessment: 3-6 months post-loss; Assessment: 9-12 months post-loss
PTSD Checklist for DSM-5 (PCL-5)
Time frame: Assessment 1: 6 months before patient's death; Assessment: 3-6 months post-loss; Assessment: 9-12 months post-loss
Dissociative Subtype of PTSD Scale (DSPS)
Time frame: Assessment 1: 6 months before patient's death; Assessment: 3-6 months post-loss; Assessment: 9-12 months post-loss
Cognitive Processing Questionnaire (CPQ)
Time frame: Assessment 1: 6 months before patient's death; Assessment: 3-6 months post-loss; Assessment: 9-12 months post-loss
The Inventory of Complicated Grief (ICG)
Time frame: Assessment 1: 6 months before patient's death; Assessment: 3-6 months post-loss; Assessment: 9-12 months post-loss
Prolonged Grief Reaction (PG13+9)
Time frame: Assessment 1: 6 months before patient's death; Assessment: 3-6 months post-loss; Assessment: 9-12 months post-loss
heart-rate/heart-rate variability
Time frame: Assessment 1: 6 months before patient's death; Assessment: 3-6 months post-loss; Assessment: 9-12 months post-loss
nail cortisol and cortisone
Time frame: Assessment 1: 6 months before patient's death; Assessment: 3-6 months post-loss; Assessment: 9-12 months post-loss
tumor necrosis factor alpha (TNF-a)
Time frame: Assessment 1: 6 months before patient's death; Assessment: 3-6 months post-loss; Assessment: 9-12 months post-loss
C-reactive protein (CRP)
Time frame: Assessment 1: 6 months before patient's death; Assessment: 3-6 months post-loss; Assessment: 9-12 months post-loss
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
Related trials for Caregiver Burden
Recruiting
Anticipated Patient and Caregiver Burden
Amyotrophic Lateral Sclerosis
Recruiting
The Coma Family Program (COMA-F): A Resilience Program for Caregivers of Patients With Severe Acute Brain Injury
Caregiver Distress, Emotional Distress
Not yet recruiting
Negotiation Training for Family Caregivers of People With Alzheimer's Disease
Alzheimer's Disease (AD), Dementia
RecruitingObservational study
Friends/Family of Individuals at Risk of Suicide Training Program
Caregiver, Caregiver Mental Health
Not yet recruiting
VICA: A Virtual Care Assistant for Dementia Caregivers
Alzheimer Dementia (AD), Caregiver Burden of People With Dementia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
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.