Clinical trial NCT03458312: Nurse-led Family and Network Consultations
Official title: Nurse-led Family and Network Consultations - Addressing Cancer-Related Symptoms and Concerns in Patients With High-grade Glioma and Their Families and Network (CARES)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High-grade Glioma
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: The Novo Nordic Foundation
First posted: 2018-03-08
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Objectives To explore the feasibility and benefits 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.

Methods This is a feasibility study in two parts: 1) a sample of patients with HGG (n=30) and their caregivers (n=30) recruited for informing the study about the family function, support and caregiver burden and 2) 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.

Part two applies a Mixed Method convergent design with a QUAL + QUAN design.

Nursing BA students at Metropolitan University College will carry out affiliated bachelor projects within CARES.

Theoretical framework Biopsychosocial Model International Classification of Functioning, Disability and Health (ICF) Use of narratives within neuro-oncology Feedback models and goal setting Symptom management theory The integrated Framework of Family System Nursing; Calgary Model Model of levels of personal and professional change

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.

Measurements

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).

Part 1, questionnaires for cohort patients (n=30) and caregivers:

The Caregiver Burden Scale (only caregivers) Hospital Anxiety and Depression Scale (HADS),(only caregivers)

The ICE Family Perceived Support Questionnaire (ICE-FPSQ) (caregiver and patient, individually) Psychometric development of the Iceland-Expressive Family Functioning Questionnaire (ICE-EFFQ) (caregiver and patient, individually)

Part 2, questionnaires for IG patients (n=30):

The M.D. Anderson Symptom Inventory-Brain Tumour Module (before FNC) HADS The Functional Assessment of Cancer Therapy-Brain (FACT-Br) ICE-FPSQ ICE-EFFQ

Questionnaires for IG family members (n=30):

The Caregiver Burden Scale HADS ICE-FPSQ ICE-EFFQ

Material from the FNC Written resume of each consultation (n=120)

Interviews:

Semi-structured telephone interviews with IG patients (n=30) and IG family member (n=30) post FNC 2 and post FNC 4 Focus group interview with project nurses post FNC 5 (n= 5 nurses)

Analysis The MDASI-BT, HADS, FACT-Br, the ICE-EFFQ, the ICE-FPSQ and Caregiver burden scale to be analysed separately.

Thematic analyses of interviews, field notes and resume according to Braun and Clarke.

The Mixed Methods analytic approach is interpretive integration, which merges, compares, contradicts and discusses the data sets in order to achieve analytic integration in meta-inference.

Time schedule May 2017 - December 2017: The preparatory phase February 2018 -August 2019: Cohort data collection March 2018- July 2018: Education of the project nurses August 2018 - February 2020: Intervention (1-year intervention with 6 months recruitment)

Clinical and research implications New model of care in expanded nurse-led consultations relying on FNC may be powerful way to facilitate strategies to improve symptom management, emotional well-being and reduce concerns among families.

This study will take at neurosurgical department and oncological department at Copenhagen University Hospital, Rigshospitalet in cooperation with neuro-oncological specialist team.

Eligibility criteria: Inclusion Criteria:

-

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: The experiences from participation in Family and network consultations (FNC)
timeFrame: At week 50 to 52
Secondary outcomes:
measure: Change in the perceived Caregiver Burden Scale over time (only caregivers)
timeFrame: At week 1-2, week 8-10, week 28-30 and week 50-52
measure: Change in the severity of depressive symptoms over time measured by the Hospital Anxiety and Depression Scale (HADS)
timeFrame: At week 1-2, week 8-10, week 28-30 and week 50-52
measure: Change in the severity of anxiety over time measured by the Hospital Anxiety and Depression Scale (HADS)
timeFrame: At week 1-2, week 8-10, week 28-30 and week 50-52
measure: 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)
timeFrame: At week 1-2, week 8-10, week 28-30 and week 50-52
measure: 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)
timeFrame: At week 1-2, week 8-10, week 28-30 and week 50-52
measure: The prevalence of symptoms over time will be measured by the M.D. Anderson Symptom Inventory-Brain Tumour Module
timeFrame: At week 1-2, week 8-10, week 28-30 and week 50-52
measure: The quality of life will be measured by The Functional Assessment of Cancer Therapy-Brain (FACT-Br)
timeFrame: At week 1-2, week 8-10, week 28-30 and week 50-52
Other outcomes:
measure: Change in the perception of the nurses professional identity
timeFrame: At week 28-30 and week 50-52
Locations:
city: Copenhagen
country: Denmark
facility: University hospital of Copenhagen, Rigshospitalet
Study officials:
References:
citation: 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.