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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Palliative Care
• Intervention / Treatment: Behavioral: The Carer Support Needs Assessment Tool (CSNAT) intervention

• Study Type: Interventional
• Enrollment (Actual): 135
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark, 9230
    • Aalborg Home Nursing
  • Esbjerg, Denmark, 6700
    • Esbjerg Home Nursing
  • Gentofte, Denmark, 2920
    • Gentofte Home Nursing
  • Gladsaxe, Denmark, 2800
    • Gladsaxe Home Nursing
  • Haderslev, Denmark, 6200
    • Haderslev Home Nursing
  • Hjørring, Denmark, 9800
    • Hjørring Home Nursing
  • Holbæk, Denmark, 4300
    • Holbæk Home Nursing
  • Næstved, Denmark, 4700
    • Næstved Home Nursing
  • Odense, Denmark, 5220
    • Odense Home Nursing
  • Silkeborg, Denmark, 8600
    • Silkeborg Home Nursing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Bispebjerg Hospital
• Collaborators: Danish Cancer Society; Home care nursing in the Municipality of Gentofte; Home care nursing in the Municipality of Gladsaxe; Home care nursing in the Municipality of Haderslev; Home care nursing in the Municipality of Holbæk; Home care nursing in the Municipality of Odense; Home care nursing in the Municipality of Aalborg; Home care nursing in the Municipality of Esbjerg; Home care nursing in the Municipality of Hjørring; Home care nursing in the Municipality of Næstved; Home care nursing in the Municipality of Silkeborg
• Investigators: Principal Investigator: Mogens Grønvold, DMSc PhD MD, Bispebjerg Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2018
• Primary Completion (Actual): October 15, 2019
• Study Completion (Anticipated): October 15, 2021

Study Registration Dates

• First Submitted: May 22, 2018
• First Submitted That Met QC Criteria: June 5, 2018
• First Posted (Actual): June 6, 2018

Study Record Updates

• Last Update Posted (Actual): August 20, 2021
• Last Update Submitted That Met QC Criteria: August 16, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Randomised controlled trial; Intervention; Caregivers; Support Needs
• Other Study ID Numbers: R173-A11289-17-S51

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No