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

NCT03548012 | Unknown

• 1 other identifier: R173-A11289-17-S51
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 10

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

Conditions

Palliative Care

Keywords

Caregivers; Support Needs; Intervention; Randomised controlled trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (32)

• Caregiver strain

  Change from baseline (enrollment) to day 28

• Positive caregiving appraisals

  Change from baseline (enrollment) to day 14

• Positive caregiving appraisals

  Change from baseline (enrollment) to day 28

• Caregiver distress

  Change from baseline (enrollment) to day 14

• Caregiver distress

  Change from baseline (enrollment) to day 28

Study Arms (2)

The Carer Support Needs Assessment Tool (CSNAT) intervention

EXPERIMENTAL

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

Behavioral: The Carer Support Needs Assessment Tool (CSNAT) intervention

Control

NO INTERVENTION

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

Interventions

The Carer Support Needs Assessment Tool (CSNAT) intervention 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.

The Carer Support Needs Assessment Tool (CSNAT) intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bispebjerg Hospital: lead
• Danish Cancer Society: collaborator
• Home care nursing in the Municipality of Gentofte: collaborator
• Home care nursing in the Municipality of Gladsaxe: collaborator
• Home care nursing in the Municipality of Haderslev: collaborator
• Home care nursing in the Municipality of Holbæk: collaborator
• Home care nursing in the Municipality of Odense: collaborator
• Aalborg Municipality: collaborator
• Home care nursing in the Municipality of Esbjerg: collaborator
• Home care nursing in the Municipality of Hjørring: collaborator
• Home care nursing in the Municipality of Næstved: collaborator
• Home care nursing in the Municipality of Silkeborg: collaborator

Study Sites (10)

Aalborg Home Nursing

Aalborg, 9230, Denmark

Location

Esbjerg Home Nursing

Esbjerg, 6700, Denmark

Location

Gentofte Home Nursing

Gentofte Municipality, 2920, Denmark

Location

Gladsaxe Home Nursing

Gladsaxe, 2800, Denmark

Location

Haderslev Home Nursing

Haderslev, 6200, Denmark

Location

Hjørring Home Nursing

Hjørring, 9800, Denmark

Location

Holbæk Home Nursing

Holbæk, 4300, Denmark

Location

Næstved Home Nursing

Næstved, 4700, Denmark

Location

Odense Home Nursing

Odense, 5220, Denmark

Location

Silkeborg Home Nursing

Silkeborg, 8600, Denmark

Location

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Mogens Grønvold, DMSc PhD MD

  Bispebjerg Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, DMSc, PhD, MD

Model Details: 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.

Study Record Dates

• First Submitted: May 22, 2018
• First Posted: June 6, 2018
• Study Start: June 15, 2018
• Primary Completion: October 15, 2019
• Study Completion: October 15, 2021
• Last Updated: August 20, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (10)