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

• ClinicalTrials.gov Identifier: NCT03548012
• Recruitment Status: Active, not recruiting
• First Posted: June 6, 2018
• Last Update Posted: August 20, 2021
• 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
• Information provided by (Responsible Party): Mogens Groenvold, Bispebjerg Hospital

Study Description

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

Condition or disease	Intervention/treatment	Phase
Palliative Care	Behavioral: The Carer Support Needs Assessment Tool (CSNAT) intervention	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 135 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• 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
• Actual Study Start Date: June 15, 2018
• Actual Primary Completion Date: October 15, 2019
• Estimated Study Completion Date: October 15, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Caregiver strain [ Time Frame: 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 :

1. Caregiver strain [ Time Frame: 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.
2. Positive caregiving appraisals [ Time Frame: 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.
3. Positive caregiving appraisals [ Time Frame: 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.
4. Caregiver distress [ Time Frame: 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
5. Caregiver distress [ Time Frame: 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
6. Satisfaction with attention from health care professionals [ Time Frame: 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
7. Satisfaction with attention from health care professionals [ Time Frame: 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
8. Satisfaction with communication with health care professionals [ Time Frame: 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
9. Satisfaction with communication with health care professionals [ Time Frame: 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
10. Satisfaction with information from health care professionals [ Time Frame: 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
11. Satisfaction with information from health care professionals [ Time Frame: 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
12. Caregiving workload [ Time Frame: 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
13. Caregiving workload [ Time Frame: 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
14. Caregiver involvement [ Time Frame: 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
15. Caregiver involvement [ Time Frame: 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
16. Help from health care professionals [ Time Frame: 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
17. Help from health care professionals [ Time Frame: 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
18. Quality of life [ Time Frame: 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
19. Quality of life [ Time Frame: 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
20. Emotional functioning [ Time Frame: 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
21. Emotional functioning [ Time Frame: 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
22. Fatigue [ Time Frame: 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
23. Fatigue [ Time Frame: 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
24. Positive emotional functioning [ Time Frame: 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
25. Positive emotional functioning [ Time Frame: 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
26. Caregiver grief [ Time Frame: 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
27. Acute hospitalizations [ Time Frame: Change from baseline (enrollment) to day 14 ]
    Number of acute patient hospitalizations
28. Acute hospitalizations [ Time Frame: Change from baseline (enrollment) to day 28 ]
    Number of acute patient hospitalizations
29. Hospice referrals (for in-patient care) [ Time Frame: Change from baseline (enrollment) to day 14 ]
    Number of patients referred to hospice in-patient care
30. Hospice referrals (for in-patient care) [ Time Frame: Change from baseline (enrollment) to day 28 ]
    Number of patients referred to hospice in-patient care
31. Survival time [ Time Frame: From enrollment to up to six months after the project recruitment period has closed ]
    Number of days the patient lives
32. Place of death [ Time Frame: From enrollment to up to six months after the project recruitment period has closed ]
    The place in which the patient dies

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

Denmark

Aalborg Home Nursing

Aalborg, Denmark, 9230

Esbjerg Home Nursing

Esbjerg, Denmark, 6700

Gentofte Home Nursing

Gentofte, Denmark, 2920

Gladsaxe Home Nursing

Gladsaxe, Denmark, 2800

Haderslev Home Nursing

Haderslev, Denmark, 6200

Hjørring Home Nursing

Hjørring, Denmark, 9800

Holbæk Home Nursing

Holbæk, Denmark, 4300

Næstved Home Nursing

Næstved, Denmark, 4700

Odense Home Nursing

Odense, Denmark, 5220

Silkeborg Home Nursing

Silkeborg, Denmark, 8600

Sponsors and Collaborators

Bispebjerg Hospital

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

More Information

• Responsible Party: Mogens Groenvold, Professor, DMSc, PhD, MD, Bispebjerg Hospital
• ClinicalTrials.gov Identifier: NCT03548012
• Other Study ID Numbers: R173-A11289-17-S51
• First Posted: June 6, 2018
• Last Update Posted: August 20, 2021
• Last Verified: August 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mogens Groenvold, Bispebjerg Hospital:

Caregivers; Support Needs; Intervention; Randomised controlled trial