Improvement of Support to Caregivers of Cancer Patients in Basic Palliative Care at Home

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Palliative Care

Intervention / Treatment
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* Behavioral: The Carer Support Needs Assessment Tool (CSNAT) intervention


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The Carer Support Needs Assessment Tool (CSNAT) intervention<br>('Standard' basic palliative care +) The Carer Support Needs Assessment Tool (CSNAT) intervention. | Behavioral: The Carer Support Needs Assessment Tool (CSNAT) intervention<br>* 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.<br>|
| No Intervention: Control<br>('Standard' basic palliative care). No intervention offered. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caregiver strain | 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. | Change from baseline (enrollment) to day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caregiver strain | 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. | Change from baseline (enrollment) to day 28 | 
| Positive caregiving appraisals | 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. | Change from baseline (enrollment) to day 14 | 
| Positive caregiving appraisals | 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. | Change from baseline (enrollment) to day 28 | 
| Caregiver distress | 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 | Change from baseline (enrollment) to day 14 | 
| Caregiver distress | 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 | Change from baseline (enrollment) to day 28 | 
| Satisfaction with attention from health care professionals | 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 | Change from baseline (enrollment) to day 14 | 
| Satisfaction with attention from health care professionals | 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 | Change from baseline (enrollment) to day 28 | 
| Satisfaction with communication with health care professionals | 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 | Change from baseline (enrollment) to day 14 | 
| Satisfaction with communication with health care professionals | 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 | Change from baseline (enrollment) to day 28 | 
| Satisfaction with information from health care professionals | 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 | Change from baseline (enrollment) to day 14 | 
| Satisfaction with information from health care professionals | 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 | Change from baseline (enrollment) to day 28 | 
| Caregiving workload | 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 | Change from baseline (enrollment) to day 14 | 
| Caregiving workload | 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 | Change from baseline (enrollment) to day 28 | 
| Caregiver involvement | 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 | Change from baseline (enrollment) to day 14 | 
| Caregiver involvement | 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 | Change from baseline (enrollment) to day 28 | 
| Help from health care professionals | 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 | Change from baseline (enrollment) to day 14 | 
| Help from health care professionals | 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 | Change from baseline (enrollment) to day 28 | 
| Quality of life | 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 | Change from baseline (enrollment) to day 14 | 
| Quality of life | 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 | Change from baseline (enrollment) to day 28 | 
| Emotional functioning | 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 | Change from baseline (enrollment) to day 14 | 
| Emotional functioning | 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 | Change from baseline (enrollment) to day 28 | 
| Fatigue | 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 | Change from baseline (enrollment) to day 14 | 
| Fatigue | 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 | Change from baseline (enrollment) to day 28 | 
| Positive emotional functioning | 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 | Change from baseline (enrollment) to day 14 | 
| Positive emotional functioning | 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 | Change from baseline (enrollment) to day 28 | 
| Caregiver grief | 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 | Measured six months after the patient's death | 
| Acute hospitalizations | Number of acute patient hospitalizations | Change from baseline (enrollment) to day 14 | 
| Acute hospitalizations | Number of acute patient hospitalizations | Change from baseline (enrollment) to day 28 | 
| Hospice referrals (for in-patient care) | Number of patients referred to hospice in-patient care | Change from baseline (enrollment) to day 14 | 
| Hospice referrals (for in-patient care) | Number of patients referred to hospice in-patient care | Change from baseline (enrollment) to day 28 | 
| Survival time | Number of days the patient lives | From enrollment to up to six months after the project recruitment period has closed | 
| Place of death | The place in which the patient dies | From enrollment to up to six months after the project recruitment period has closed | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Caregivers, Support Needs, Intervention, Randomised controlled trial