Palliative CarePiHNCT03548012
Improvement of Support to Caregivers of Cancer Patients in Basic Palliative Care at Home
A study testing The Carer Support Needs Assessment Tool (CSNAT) intervention in people with Palliative Care, run by Bispebjerg Hospital at 10 sites in Denmark.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palliative Care
- What is being tested?
- The Carer Support Needs Assessment Tool (CSNAT) intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 10 sitesDenmark
- Study dates
- 15 Jun 2018to 15 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Denmark10 sites
Aalborg Home Nursing
Aalborg, 9230
Esbjerg Home Nursing
Esbjerg, 6700
Gentofte Home Nursing
Gentofte Municipality, 2920
Gladsaxe Home Nursing
Gladsaxe, 2800
Haderslev Home Nursing
Haderslev, 6200
Hjørring Home Nursing
Hjørring, 9800
Holbæk Home Nursing
Holbæk, 4300
Næstved Home Nursing
Næstved, 4700
Odense Home Nursing
Odense, 5220
Silkeborg Home Nursing
Silkeborg, 8600
About this study
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
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
- Conditions
- Palliative Care
- Being tested
- The Carer Support Needs Assessment Tool (CSNAT) intervention
- Keywords
- Caregivers, Support Needs, Intervention, Randomised controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Carer Support Needs Assessment Tool (CSNAT) interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| The Carer Support Needs Assessment Tool (CSNAT) intervention | Experimental | ('Standard' basic palliative care +) The Carer Support Needs Assessment Tool (CSNAT) intervention. Receives: Behavioral: The Carer Support Needs Assessment Tool (CSNAT) intervention |
| Control | No intervention | ('Standard' basic palliative care). No intervention offered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline (enrollment) to day 14
Secondary outcomes (32)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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: Measured six months after the patient's death
Acute hospitalizations
Number of acute patient hospitalizations
Measured: Change from baseline (enrollment) to day 14
Acute hospitalizations
Number of acute patient hospitalizations
Measured: Change from baseline (enrollment) to day 28
Hospice referrals (for in-patient care)
Number of patients referred to hospice in-patient care
Measured: Change from baseline (enrollment) to day 14
Hospice referrals (for in-patient care)
Number of patients referred to hospice in-patient care
Measured: Change from baseline (enrollment) to day 28
Survival time
Number of days the patient lives
Measured: From enrollment to up to six months after the project recruitment period has closed
Place of death
The place in which the patient dies
Measured: From enrollment to up to six months after the project recruitment period has closed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start15 Jun 2018
- Primary completion15 Oct 2019
- Study completion15 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- 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, Aalborg Municipality, 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
- Responsible party
- Principal investigator, Mogens Groenvold, Bispebjerg Hospital
- Investigators
- Mogens Grønvold, DMSc PhD MD, Principal investigator, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03548012
- Sponsor's protocol ID
- R173-A11289-17-S51
- Acronym
- PiH
- Status last verified
- Aug 2021
- First submitted
- 22 May 2018
- Last updated
- 20 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03548012
- Acronym / sponsor ID
- PiH / R173-A11289-17-S51
- Conditions
- Palliative Care
- Keywords
- Caregivers, Support Needs, Intervention, Randomised controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- 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, Aalborg Municipality, 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
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 15 Oct 2019 (actual)
- Study completion
- 15 Oct 2021 (estimated)
- First posted
- 6 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| The Carer Support Needs Assessment Tool (CSNAT) intervention | Experimental | Behavioral: The Carer Support Needs Assessment Tool (CSNAT) intervention('Standard' basic palliative care +) The Carer Support Needs Assessment Tool (CSNAT) intervention. |
| Control | No intervention | –('Standard' basic palliative care). No intervention offered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Carer Support Needs Assessment Tool (CSNAT) interventionThe 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. | Behavioural | The Carer Support Needs Assessment Tool (CSNAT) intervention |
Primary outcome
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.
32 secondary outcomes
Caregiver strain
Time frame: Change from baseline (enrollment) to day 28
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
Time frame: Change from baseline (enrollment) to day 14
Caregiver distress
Time frame: Change from baseline (enrollment) to day 28
Satisfaction with 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
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
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
Time frame: Change from baseline (enrollment) to day 14
Caregiving workload
Time frame: Change from baseline (enrollment) to day 28
Caregiver 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
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
Time frame: Change from baseline (enrollment) to day 14
Quality of life
Time frame: Change from baseline (enrollment) to day 28
Emotional functioning
Time frame: Change from baseline (enrollment) to day 14
Emotional functioning
Time frame: Change from baseline (enrollment) to day 28
Fatigue
Time frame: Change from baseline (enrollment) to day 14
Fatigue
Time frame: Change from baseline (enrollment) to day 28
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
Time frame: Measured six months after the patient's death
Acute hospitalizations
Time frame: Change from baseline (enrollment) to day 14
Acute hospitalizations
Time frame: Change from baseline (enrollment) to day 28
Hospice referrals (for in-patient care)
Time frame: Change from baseline (enrollment) to day 14
Hospice referrals (for in-patient care)
Time frame: Change from baseline (enrollment) to day 28
Survival time
Time frame: From enrollment to up to six months after the project recruitment period has closed
Place of death
Time frame: From enrollment to up to six months after the project recruitment period has closed
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mogens Grønvold, DMSc PhD MD principal investigator
Bispebjerg Hospital
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Carer Support Needs Assessment Tool (CSNAT) intervention in people with Palliative Care, run by Bispebjerg Hospital at 10 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregiver strain (time frame: Change from baseline (enrollment) to day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2021.