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

Palliative Care Clinical Trial

— PiH  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03548012
• Other study ID #: R173-A11289-17-S51
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 15, 2018
• Est. completion date: October 15, 2021

Study information

• Verified date: August 2021
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 135
• Est. completion date: October 15, 2021
• Est. primary completion date: October 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Palliative Care

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.

Locations

Country	Name	City	State
Denmark	Aalborg Home Nursing	Aalborg
Denmark	Esbjerg Home Nursing	Esbjerg
Denmark	Gentofte Home Nursing	Gentofte
Denmark	Gladsaxe Home Nursing	Gladsaxe
Denmark	Haderslev Home Nursing	Haderslev
Denmark	Hjørring Home Nursing	Hjørring
Denmark	Holbæk Home Nursing	Holbæk
Denmark	Næstved Home Nursing	Næstved
Denmark	Odense Home Nursing	Odense
Denmark	Silkeborg Home Nursing	Silkeborg

Sponsors (12)

Lead Sponsor

Collaborator

Bispebjerg Hospital

Danish Cancer Society, Home care nursing in the Municipality of Aalborg, Home care nursing in the Municipality of Esbjerg, 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 Hjørring, Home care nursing in the Municipality of Holbæk, Home care nursing in the Municipality of Næstved, Home care nursing in the Municipality of Odense, Home care nursing in the Municipality of Silkeborg

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Acute hospitalizations	Number of acute patient hospitalizations	Change from baseline (enrollment) to day 14
Secondary	Acute hospitalizations	Number of acute patient hospitalizations	Change from baseline (enrollment) to day 28
Secondary	Hospice referrals (for in-patient care)	Number of patients referred to hospice in-patient care	Change from baseline (enrollment) to day 14
Secondary	Hospice referrals (for in-patient care)	Number of patients referred to hospice in-patient care	Change from baseline (enrollment) to day 28
Secondary	Survival time	Number of days the patient lives	From enrollment to up to six months after the project recruitment period has closed
Secondary	Place of death	The place in which the patient dies	From enrollment to up to six months after the project recruitment period has closed