Testing a Caregiver-led Intervention to Improve Support to Caregivers of Cancer Patients in Palliative Care at Home: a Stepped Wedge (Cluster) Randomized Controlled Trial

Bispebjerg Hospital10 sites in 1 country135 target enrollmentJune 15, 2018

ConditionsPalliative Care

Overview

Phase: N/A
Intervention: Not specified
Conditions: Palliative Care
Sponsor: Bispebjerg Hospital
Enrollment: 135
Locations: 10
Primary Endpoint: Caregiver strain
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of the project is to evaluate the use of the caregiver-led 'CSNAT intervention' to identify, prioritize and address support needs among caregivers of cancer patients who are starting in basic palliative care at home in Denmark

Registry

clinicaltrials.gov

Start Date

June 15, 2018

End Date

October 15, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bispebjerg Hospital

Responsible Party

Principal Investigator

Mogens Groenvold

Professor, DMSc, PhD, MD

Bispebjerg Hospital

Eligibility Criteria

Inclusion Criteria

•The patient should have advanced cancer
•The caregiver and patient should be able to read and understand Danish
•The caregiver and patient should give written informed consent
•The patient should be newly referred to basic palliative care (BPC) by home nurses in the municipality.

Exclusion Criteria

•The caregiver is viewed by the practitioners as being too distressed to be asked about participation
•The caregiver has a known cognitive impairment precluding participation (based on the practitioners' clinical judgement)

Outcomes

Primary Outcomes

Caregiver strain

Time Frame: Change from baseline (enrollment) to day 14

Caregiver strain is measured by the subscale 'Caregiver Strain' in the Family Appraisal of Caregiving Questionnaire for Palliative Care (FACQ-PC). Subscale score range: 1-5. A higher score represents a worse outcome, i.e. more caregiver strain.

Secondary Outcomes

Caregiver distress(Change from baseline (enrollment) to day 28)
Caregiver involvement(Change from baseline (enrollment) to day 28)
Emotional functioning(Change from baseline (enrollment) to day 28)
Fatigue(Change from baseline (enrollment) to day 28)
Acute hospitalizations(Change from baseline (enrollment) to day 28)
Survival time(From enrollment to up to six months after the project recruitment period has closed)
Caregiver strain(Change from baseline (enrollment) to day 28)
Satisfaction with communication with health care professionals(Change from baseline (enrollment) to day 28)
Caregiver grief(Measured six months after the patient's death)
Place of death(From enrollment to up to six months after the project recruitment period has closed)
Satisfaction with information from health care professionals(Change from baseline (enrollment) to day 28)
Caregiving workload(Change from baseline (enrollment) to day 28)
Positive caregiving appraisals(Change from baseline (enrollment) to day 28)
Satisfaction with attention from health care professionals(Change from baseline (enrollment) to day 28)
Help from health care professionals(Change from baseline (enrollment) to day 28)
Positive emotional functioning(Change from baseline (enrollment) to day 28)
Quality of life(Change from baseline (enrollment) to day 28)
Hospice referrals (for in-patient care)(Change from baseline (enrollment) to day 28)