Palliative Care
Conditions
Keywords
Caregivers, Support needs, Intervention, Randomised controlled trial
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 patients who are starting in specialized palliative care at home in Denmark
Interventions
The CSNAT intervention is a caregiver-led approach where the caregiver first identifies his/her needs of support in the CSNAT, which consists of 14 support domains. Then the practitioner facilitates the intervention where the caregiver prioritizes which domains to discuss. In the conversation, the caregiver's domain priorities and subsequently identified support needs are discussed with the practitioner to agree on actions/solutions and a shared action plan. The intervention will be offered each caregiver twice: the first time between 0 and 13 days after enrollment, and the second time between 15 and 27 days after enrollment.
Sponsors
Danish Cancer Society
The A.P. Moeller Foundation
The Palliative Unit, Amager-Hvidovre Hospital
Rigshospitalet, Denmark
Odense University Hospital
Arresoedal Hospice
Diakonissestiftelsens Hospice
Hospice Soendergaard
Nordsjaellands Hospital
The Palliative Team NORTH, University Hospital Sjaelland
Soenderjylland Hospital
Bispebjerg Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
A stepped wedge cluster randomized controlled trial. All clusters (i.e., specialized palliative care (SPC) units) will start as controls and will change to intervention at various times determined by randomization. In this way, all SPC units will contribute to control and intervention groups, thus accounting for variation between SPC units.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 specialized palliative care (SPC) in the SPC unit.
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Caregiver strain | 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
| Measure | Time frame | Description |
|---|---|---|
| Positive caregiving appraisals | Change from baseline (enrollment) to day 14 | Positive caregiving appraisals is measured by the subscale 'Positive caregiving appraisals' in the Family Appraisal of Caregiving Questionnaire for Palliative Care (FACQ-PC). Subscale score range: 1-5. A higher score represents a better outcome, i.e. more positive caregiving appraisals. |
| Caregiver distress | Change from baseline (enrollment) to day 14 | Caregiver distress is measured by the subscale 'Caregiver distress' 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 distress. |
| Satisfaction with attention from health care professionals | Change from baseline (enrollment) to day 14 | Measured by the subscale 'Lack of attention from health care professionals on the caregivers' wellbeing' in the Cancer Caregiving Tasks, Consequences and Needs Questionnaire (CaTCoN). Subscale score range: 0-100. A higher score represents a worse outcome, i.e. more lack of attention from health care professionals |
| Satisfaction with communication with health care professionals | Change from baseline (enrollment) to day 14 | Measured by the subscale 'Problems with the quality of information from and communication with health care professionals' in the Cancer Caregiving Tasks, Consequences and Needs Questionnaire (CaTCoN). Subscale score range: 0-100. A higher score represents a worse outcome, i.e. more problems with the quality of information from and communication with health care professionals |
| Satisfaction with information from health care professionals | Change from baseline (enrollment) to day 14 | Measured with selected items from the subscale 'Lack of information from health care professionals' in the Cancer Caregiving Tasks, Consequences and Needs Questionnaire (CaTCoN). Item/subscale score range: 0-100. A higher score represents a worse outcome, i.e. more lack of information from health care professionals |
| Caregiving workload | Change from baseline (enrollment) to day 14 | Measured with selected items from the subscale 'Caregiving workload' in the Cancer Caregiving Tasks, Consequences and Needs Questionnaire (CaTCoN). Item/subscale score range: 0-100. A higher score represents a worse outcome, i.e. more caregiving workload |
| Caregiver involvement | Change from baseline (enrollment) to day 14 | Measured with item 12 in the Caregiving Tasks, Consequences and Needs Questionnaire (CaTCoN). Item score range: 0-100. A higher score represents a worse outcome, i.e. more caregiver dissatisfaction with involvement |
| Help from health care professionals | Change from baseline (enrollment) to day 14 | Measured with two newly developed items which ask whether the health care professionals have talked with the caregiver about what burdens them, and whether the health care professionals have helped with these burdens. Item score range: 0-100. A higher score represents a worse outcome, i.e. less help from health care professionals |
| Caregiver strain | Change from baseline (enrollment) to day 28 | 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. |
| Emotional functioning | Change from baseline (enrollment) to day 14 | Measured by the four emotional functioning items in EORTC Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) supplemented with three selected items from the EORTC Computerized Adaptive Test (CAT) emotional functioning item bank. Item/subscale score range: 0-100. A higher score represents a better outcome, i.e. better emotional functioning |
| Fatigue | Change from baseline (enrollment) to day 14 | Measured by the three fatigue items in EORTC Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) supplemented with three selected items from the EORTC Computerized Adaptive Test (CAT) fatigue item bank. Item/subscale score range: 0-100. A higher score represents a worse outcome, i.e. more fatigue |
| Positive emotional functioning | Change from baseline (enrollment) to day 14 | Measured by five positively formulated items concerning emotional functioning which were excluded from the EORTC Computerized Adaptive Test (CAT) emotional functioning bank during the development of the item bank. Item score range: 0-100. A higher score represents a better outcome, i.e. more positive emotional functioning |
| Caregiver grief | Measured six months after the patient's death | Measured by the Prolonged Grief Scale-13 (PG-13). Symptom subscale score range: 9-45. A higher score represents a worse outcome, i.e. higher level of prolonged grief symptoms |
| Acute hospitalizations | From enrollment to day 14 | Number of acute patient hospitalizations |
| Hospice referrals (for in-patient care) | From enrollment to day 14 | Number of patients referred to hospice in-patient care |
| Survival time | From enrollment to up to six months after the project recruitment period has closed | Number of days the patient lives |
| Place of death | From enrollment to up to six months after the project recruitment period has closed | The place in which the patient dies |
| Quality of life | Change from baseline (enrollment) to day 14 | Measured by the two items assessing overall health and quality of life in the EORTC Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Item score range: 0-100. A higher score represents a better outcome, i.e. better quality of life |
Countries
Denmark
Outcome results
None listed