Improvement of Support to Caregivers of Cancer Patients in Basic Palliative Care at Home
- Conditions
- Palliative Care
- Interventions
- Behavioral: The Carer Support Needs Assessment Tool (CSNAT) intervention
- Registration Number
- NCT03548012
- Lead Sponsor
- Bispebjerg Hospital
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 135
- 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.
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description The Carer Support Needs Assessment Tool (CSNAT) intervention The Carer Support Needs Assessment Tool (CSNAT) intervention ('Standard' basic palliative care +) The Carer Support Needs Assessment Tool (CSNAT) intervention.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Caregiver involvement Change from baseline (enrollment) to day 28 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
Caregiver distress Change from baseline (enrollment) to day 28 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
Emotional functioning Change from baseline (enrollment) to day 28 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 28 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
Acute hospitalizations Change from baseline (enrollment) to day 28 Number of acute patient hospitalizations
Survival time From enrollment to up to six months after the project recruitment period has closed Number of days the patient lives
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.
Satisfaction with communication with health care professionals Change from baseline (enrollment) to day 28 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
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
Place of death From enrollment to up to six months after the project recruitment period has closed The place in which the patient dies
Satisfaction with information from health care professionals Change from baseline (enrollment) to day 28 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 28 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
Positive caregiving appraisals Change from baseline (enrollment) to day 28 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.
Satisfaction with attention from health care professionals Change from baseline (enrollment) to day 28 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
Help from health care professionals Change from baseline (enrollment) to day 28 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
Positive emotional functioning Change from baseline (enrollment) to day 28 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
Quality of life Change from baseline (enrollment) to day 28 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
Hospice referrals (for in-patient care) Change from baseline (enrollment) to day 28 Number of patients referred to hospice in-patient care
Trial Locations
- Locations (10)
Holbæk Home Nursing
🇩🇰Holbæk, Denmark
Silkeborg Home Nursing
🇩🇰Silkeborg, Denmark
Haderslev Home Nursing
🇩🇰Haderslev, Denmark
Esbjerg Home Nursing
🇩🇰Esbjerg, Denmark
Aalborg Home Nursing
🇩🇰Aalborg, Denmark
Gentofte Home Nursing
🇩🇰Gentofte, Denmark
Gladsaxe Home Nursing
🇩🇰Gladsaxe, Denmark
Hjørring Home Nursing
🇩🇰Hjørring, Denmark
Næstved Home Nursing
🇩🇰Næstved, Denmark
Odense Home Nursing
🇩🇰Odense, Denmark