Caregiver Stress and Bereavement

NCT05867706 | Recruiting DMC

• 1 other identifier: KLS-5643-08-2022
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Caregiver Burden; Bereavement; Cancer

Keywords

caregiver; bereavement; stress; biomarkers; cancer; palliative care

Outcome Measures

Primary Outcomes (2)

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

  Depression

  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

  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)

  Assessment 1: 6 months before patient's death

• Physical Health Questionnaire (PHQ-D)

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

• Charlson Comorbidity Index (CC)

  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)

  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)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead
• University of Salzburg: collaborator
• University of California: collaborator

Study Sites (1)

University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Nail clip blood serum

MeSH Terms

Conditions

Caregiver Burden; Neoplasms

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Central Study Contacts

Annina Seiler, PD PhD

CONTACT

+41 43 253 04 02; annina.seiler@usz.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2023
• First Posted: May 22, 2023
• Study Start: October 1, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 4, 2025

Record last verified: 2025-04

Locations

CH (1)