Nurse-led Family and Network Consultations

NCT03458312 | Completed

• 1 other identifier: CARES
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

Patients diagnosed with high-grade gliomas (HGG) experience a complex symptom burden including high-levels concerns. As a consequence to this life-threatening disease, the rely on close contact with a specialized neuro-oncological team as well as support and practical assistance from their families. However, multidimensional burden of caregivers has been reported. CARES seeks to facilitate and activate the existing resources within the patient and the network using a new model of systematic family care approach. Specialized neuro-oncological nurses are responsible for an expanded area providing an opportunity for the nursing profession to establish a new model of nursing care. This may not only benefit the patients and their families but also contribute to strengthen the nurses' professional identity and support further development of neuro-oncological specialist team.

Conditions

High-grade Glioma

Outcome Measures

Primary Outcomes (1)

• The experiences from participation in Family and network consultations (FNC)

  Interviews seek the perspectives on the life situation related to the participation of FNC

  At week 50 to 52

Secondary Outcomes (7)

• Change in the perceived Caregiver Burden Scale over time (only caregivers)

  At week 1-2, week 8-10, week 28-30 and week 50-52

• Change in the severity of depressive symptoms over time measured by the Hospital Anxiety and Depression Scale (HADS)

  At week 1-2, week 8-10, week 28-30 and week 50-52

• Change in the severity of anxiety over time measured by the Hospital Anxiety and Depression Scale (HADS)

  At week 1-2, week 8-10, week 28-30 and week 50-52

• Changes in the perception of received support from nurses will be measured by the ICE Family Perceived Support Questionnaire (ICE-FPSQ) (caregiver and patient, individually)

  At week 1-2, week 8-10, week 28-30 and week 50-52

• The perceived changes of the functioning within a Family will be measured by the Psychometric development of the Iceland-Expressive Family Functioning Questionnaire (ICE-EFFQ) (caregiver and patient, individually)

  At week 1-2, week 8-10, week 28-30 and week 50-52

Other Outcomes (1)

• Change in the perception of the nurses professional identity

  At week 28-30 and week 50-52

Study Arms (2)

Family and Network support measurements

NO INTERVENTION

The perceived 'Family support' and 'Caregiver burden' (FNC) will be measured among 30 families. Test time points: Post 1. FNC (week 1-2), post FNC 2 (week 8-10) and post FNC 3 (week 28-30) and post the 4. FNC (week 50-52)

Family and network consultations

EXPERIMENTAL

Intervention: FNC IG will receive four family consultations over 52 weeks relying on the Calgary model and Patient-reported outcome on symptom management and concerns.

Behavioral: Family and Network Consultations

Interventions

Family and Network Consultations BEHAVIORAL

Family and Network Consultation' (FNC) seek to identify and address patients' symptoms/concerns and caregiver burden on one side and identify the resources and opportunities to ease their burdens on the other side. Intervention: FNC IG will receive four family consultations over 52 weeks relying on the Calgary model and Patient-reported outcome on symptom management and concerns.

Family and network consultations

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients in the cohort (n=30) and IG (n=30) and their families will be recruited within the first week after surgery. Included are:
• Patients ≥ 18 years of age and newly diagnosed with HGG (WHO classification grade III/IV) after biopsy or operation.
• The patients and their family members and network must be able to speak and understand Danish.
• Provide informed consent

You may not qualify if:

• Excluded are • Patients without family or any network. There are no restrictions regarding the family members/network relation to the patient as long as the patient has accepted the person(s) as being a close relative or friend that the patient allows to participate in the FNC. Written informed consent will be obtained before discharge from the hospital or by telephone after discharge.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• The Novo Nordic Foundation: collaborator

Study Sites (1)

University hospital of Copenhagen, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (1)

• Piil K, Laegaard Skovhus S, Tolver A, Jarden M. Neuro-Oncological Symptoms: A Longitudinal Quantitative Study of Family Function, Perceived Support, and Caregiver Burden. J Fam Nurs. 2022 Feb;28(1):43-56. doi: 10.1177/10748407211029986. Epub 2021 Jul 21.

  PMID: 34286624 DERIVED

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: a sample of patients with HGG (n=30) and their caregivers (n=30) recruited for intervention group (IG) with 'Nurse-led Family and Network Consultations' using pretest and posttest measures.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D. Research and quality manager

Model Details: To explore the feasibility of a 'Nurse-led Family and Network Consultation' (FNC) that seek to identify and address patients' symptoms/concerns and caregiver burden on one side and identify the resources and opportunities to ease their burdens on the other side. To explore the impact of these nurse consultations on the nurses' perception of autonomy, self-esteem, and confidence, representing their professional identity

Study Record Dates

• First Submitted: January 5, 2018
• First Posted: March 8, 2018
• Study Start: April 9, 2018
• Primary Completion: July 1, 2020
• Study Completion: November 1, 2023
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)