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

NCT ID: NCT03548012

Last Updated: 2021-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-15

Study Completion Date

2021-10-15

Brief Summary

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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

Detailed Description

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Conditions

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Palliative Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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The Carer Support Needs Assessment Tool (CSNAT) intervention

('Standard' basic palliative care +) The Carer Support Needs Assessment Tool (CSNAT) intervention.

Group Type EXPERIMENTAL

The Carer Support Needs Assessment Tool (CSNAT) intervention

Intervention Type BEHAVIORAL

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.

Control

('Standard' basic palliative care). No intervention offered.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Danish Cancer Society

OTHER

Sponsor Role collaborator

Home care nursing in the Municipality of Gentofte

UNKNOWN

Sponsor Role collaborator

Home care nursing in the Municipality of Gladsaxe

UNKNOWN

Sponsor Role collaborator

Home care nursing in the Municipality of Haderslev

UNKNOWN

Sponsor Role collaborator

Home care nursing in the Municipality of Holbæk

UNKNOWN

Sponsor Role collaborator

Home care nursing in the Municipality of Odense

UNKNOWN

Sponsor Role collaborator

Aalborg Municipality

OTHER

Sponsor Role collaborator

Home care nursing in the Municipality of Esbjerg

UNKNOWN

Sponsor Role collaborator

Home care nursing in the Municipality of Hjørring

UNKNOWN

Sponsor Role collaborator

Home care nursing in the Municipality of Næstved

UNKNOWN

Sponsor Role collaborator

Home care nursing in the Municipality of Silkeborg

UNKNOWN

Sponsor Role collaborator

Bispebjerg Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mogens Groenvold

Professor, DMSc, PhD, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mogens Grønvold, DMSc PhD MD

Role: PRINCIPAL_INVESTIGATOR

Bispebjerg Hospital

Locations

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Aalborg Home Nursing

Aalborg, , Denmark

Site Status

Esbjerg Home Nursing

Esbjerg, , Denmark

Site Status

Gentofte Home Nursing

Gentofte Municipality, , Denmark

Site Status

Gladsaxe Home Nursing

Gladsaxe, , Denmark

Site Status

Haderslev Home Nursing

Haderslev, , Denmark

Site Status

Hjørring Home Nursing

Hjørring, , Denmark

Site Status

Holbæk Home Nursing

Holbæk, , Denmark

Site Status

Næstved Home Nursing

Næstved, , Denmark

Site Status

Odense Home Nursing

Odense, , Denmark

Site Status

Silkeborg Home Nursing

Silkeborg, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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R173-A11289-17-S51

Identifier Type: -

Identifier Source: org_study_id

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