Clinical trial NCT03548012: Improvement of Support to Caregivers of Cancer Patients in Basic Palliative Care at Home
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Palliative Care
Keywords: Caregivers
Support Needs
Intervention
Randomised controlled trial
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: Danish Cancer Society
name: Home care nursing in the Municipality of Gentofte
name: Home care nursing in the Municipality of Gladsaxe
name: Home care nursing in the Municipality of Haderslev
name: Home care nursing in the Municipality of Holbæk
name: Home care nursing in the Municipality of Odense
name: Aalborg Municipality
name: Home care nursing in the Municipality of Esbjerg
name: Home care nursing in the Municipality of Hjørring
name: Home care nursing in the Municipality of Næstved
name: Home care nursing in the Municipality of Silkeborg
First posted: 2018-06-06
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A stepped wedge cluster randomized controlled trial. All clusters (i.e., municipalities) will start as controls and will change to intervention at various times determined by randomization. In this way, all municipalities will contribute to control and intervention groups, thus accounting for variation between municipalities.
Primary purpose: HEALTH_SERVICES_RESEARCH

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


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)

Primary outcomes:
measure: Caregiver strain
timeFrame: Change from baseline (enrollment) to day 14
Secondary outcomes:
measure: Caregiver strain
timeFrame: Change from baseline (enrollment) to day 28
measure: Positive caregiving appraisals
timeFrame: Change from baseline (enrollment) to day 14
measure: Positive caregiving appraisals
timeFrame: Change from baseline (enrollment) to day 28
measure: Caregiver distress
timeFrame: Change from baseline (enrollment) to day 14
measure: Caregiver distress
timeFrame: Change from baseline (enrollment) to day 28
measure: Satisfaction with attention from health care professionals
timeFrame: Change from baseline (enrollment) to day 14
measure: Satisfaction with attention from health care professionals
timeFrame: Change from baseline (enrollment) to day 28
measure: Satisfaction with communication with health care professionals
timeFrame: Change from baseline (enrollment) to day 14
measure: Satisfaction with communication with health care professionals
timeFrame: Change from baseline (enrollment) to day 28
measure: Satisfaction with information from health care professionals
timeFrame: Change from baseline (enrollment) to day 14
measure: Satisfaction with information from health care professionals
timeFrame: Change from baseline (enrollment) to day 28
measure: Caregiving workload
timeFrame: Change from baseline (enrollment) to day 14
measure: Caregiving workload
timeFrame: Change from baseline (enrollment) to day 28
measure: Caregiver involvement
timeFrame: Change from baseline (enrollment) to day 14
measure: Caregiver involvement
timeFrame: Change from baseline (enrollment) to day 28
measure: Help from health care professionals
timeFrame: Change from baseline (enrollment) to day 14
measure: Help from health care professionals
timeFrame: Change from baseline (enrollment) to day 28
measure: Quality of life
timeFrame: Change from baseline (enrollment) to day 14
measure: Quality of life
timeFrame: Change from baseline (enrollment) to day 28
measure: Emotional functioning
timeFrame: Change from baseline (enrollment) to day 14
measure: Emotional functioning
timeFrame: Change from baseline (enrollment) to day 28
measure: Fatigue
timeFrame: Change from baseline (enrollment) to day 14
measure: Fatigue
timeFrame: Change from baseline (enrollment) to day 28
measure: Positive emotional functioning
timeFrame: Change from baseline (enrollment) to day 14
measure: Positive emotional functioning
timeFrame: Change from baseline (enrollment) to day 28
measure: Caregiver grief
timeFrame: Measured six months after the patient's death
measure: Acute hospitalizations
timeFrame: Change from baseline (enrollment) to day 14
measure: Acute hospitalizations
timeFrame: Change from baseline (enrollment) to day 28
measure: Hospice referrals (for in-patient care)
timeFrame: Change from baseline (enrollment) to day 14
measure: Hospice referrals (for in-patient care)
timeFrame: Change from baseline (enrollment) to day 28
measure: Survival time
timeFrame: From enrollment to up to six months after the project recruitment period has closed
measure: Place of death
timeFrame: From enrollment to up to six months after the project recruitment period has closed
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg Home Nursing
city: Esbjerg
country: Denmark
facility: Esbjerg Home Nursing
city: Gentofte
country: Denmark
facility: Gentofte Home Nursing
city: Gladsaxe
country: Denmark
facility: Gladsaxe Home Nursing
city: Haderslev
country: Denmark
facility: Haderslev Home Nursing
city: Hjørring
country: Denmark
facility: Hjørring Home Nursing
city: Holbæk
country: Denmark
facility: Holbæk Home Nursing
city: Næstved
country: Denmark
facility: Næstved Home Nursing
city: Odense
country: Denmark
facility: Odense Home Nursing
city: Silkeborg
country: Denmark
facility: Silkeborg Home Nursing
Study officials:
affiliation: Bispebjerg Hospital
name: Mogens Grønvold, DMSc PhD MD
role: PRINCIPAL_INVESTIGATOR
References: