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

Bispebjerg Hospital135 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

135

Conditions

Palliative Care

Interventions

The Carer Support Needs Assessment Tool (CSNAT) interventionBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (10)

Aalborg Home Nursing

Aalborg, Denmark

Esbjerg Home Nursing

Esbjerg, Denmark

Gentofte Home Nursing

Gentofte Municipality, Denmark

Gladsaxe Home Nursing

Gladsaxe, Denmark

Outcomes

Primary Outcomes

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.

Time frame: Change from baseline (enrollment) to day 14

Secondary Outcomes

Caregiver strain

Time frame: 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.

Time frame: Change from baseline (enrollment) to day 14

Positive caregiving appraisals

Time frame: 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

Time frame: Change from baseline (enrollment) to day 14

Data from ClinicalTrials.gov

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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, Denmark

Caregiver distress

Time frame: 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

Time frame: Change from baseline (enrollment) to day 14

Satisfaction with attention from health care professionals

Time frame: 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

Time frame: Change from baseline (enrollment) to day 14

Satisfaction with communication with health care professionals

Time frame: 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

Time frame: Change from baseline (enrollment) to day 14

Satisfaction with information from health care professionals

Time frame: 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

Time frame: Change from baseline (enrollment) to day 14

Caregiving workload

Time frame: 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

Time frame: Change from baseline (enrollment) to day 14

Caregiver involvement

Time frame: 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

Time frame: Change from baseline (enrollment) to day 14

Help from health care professionals

Time frame: 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

Time frame: Change from baseline (enrollment) to day 14

Quality of life

Time frame: 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

Time frame: Change from baseline (enrollment) to day 14

Emotional functioning

Time frame: 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

Time frame: Change from baseline (enrollment) to day 14

Fatigue

Time frame: 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

Time frame: Change from baseline (enrollment) to day 14

Positive emotional functioning

Time frame: 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

Time frame: Measured six months after the patient's death

Acute hospitalizations

Number of acute patient hospitalizations

Time frame: Change from baseline (enrollment) to day 14

Acute hospitalizations

Number of acute patient hospitalizations

Time frame: Change from baseline (enrollment) to day 28

Hospice referrals (for in-patient care)

Number of patients referred to hospice in-patient care

Time frame: Change from baseline (enrollment) to day 14

Hospice referrals (for in-patient care)

Number of patients referred to hospice in-patient care

Time frame: Change from baseline (enrollment) to day 28

Survival time

Number of days the patient lives

Time frame: From enrollment to up to six months after the project recruitment period has closed

Place of death

The place in which the patient dies

Time frame: From enrollment to up to six months after the project recruitment period has closed