Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
114 participants
INTERVENTIONAL
2018-04-09
2023-11-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
To explore the impact of these nurse consultations on the nurses' perception of autonomy, self-esteem, and confidence, representing their professional identity
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Family and Network support measurements
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)
No interventions assigned to this group
Family and network consultations
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
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Family and Network Consultations
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The Novo Nordic Foundation
OTHER
Rigshospitalet, Denmark
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Karin Piil
Ph.D. Research and quality manager
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University hospital of Copenhagen, Rigshospitalet
Copenhagen, , Denmark
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CARES
Identifier Type: -
Identifier Source: org_study_id