Caregiver Stress and Bereavement
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Zurich
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Significant visual or auditory problems, cognitive impairment,
morbid obesity (body mass index ≥40 kg/m2,
alcohol or drug abuse
active malignancy
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
The Center for Epidemiological Studies Depression Scale (CES-D)
Depression
Time frame
Assessment 1: 6 months before patient's death; Assessment: 3-6 months post-loss; Assessment: 9-12 months post-loss2
interleukine-6 (IL-6)
Measure of inflammation
Time frame
Assessment 1: 6 months before patient's death; Assessment: 3-6 months post-loss; Assessment: 9-12 months post-lossSecondary outcomes
1
The Stress and Adversity Inventory (STRAIN)
Adverse life experiences
Time frame
Assessment 1: 6 months before patient's death2
Physical Health Questionnaire (PHQ-D)
Physical Health
Time frame
Assessment 1: 6 months before patient's death; Assessment: 3-6 months post-loss; Assessment: 9-12 months post-loss3
Charlson Comorbidity Index (CC)
Comorbidities
Time frame
Assessment 1: 6 months before patient's death; Assessment: 3-6 months post-loss; Assessment: 9-12 months post-loss4
The Perceived Stress Scale (PSS)
Stress
Time frame
Assessment 1: 6 months before patient's death; Assessment: 3-6 months post-loss; Assessment: 9-12 months post-lossSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Zurich
Lead sponsor
University of Salzburg
Collaborator
University of California
Collaborator
Source ClinicalTrials.gov