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Trial Title:
Caregiver Stress and Bereavement
NCT ID:
NCT05867706
Condition:
Caregiver Burden
Bereavement
Cancer
Conditions: Official terms:
Caregiver Burden
Conditions: Keywords:
caregiver
bereavement
stress
biomarkers
cancer
palliative care
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
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 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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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)
- severe hypertension (>200/120 mmHg)
- regular use of medication with major immunological consequences (e.g.,
corticosteroids, immunosuppressive therapy)
- pregnant or breast-feeding
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Start date:
July 2024
Completion date:
December 2027
Lead sponsor:
Agency:
University of Zurich
Agency class:
Other
Collaborator:
Agency:
University of Salzburg
Agency class:
Other
Collaborator:
Agency:
University of California
Agency class:
Other
Source:
University of Zurich
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05867706