High-grade GliomaCARESNCT03458312
Nurse-led Family and Network Consultations
A study testing Family and Network Consultations in people with High-grade Glioma, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- High-grade Glioma
- What is being tested?
- Family and Network Consultations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteDenmark
- Study dates
- 9 Apr 2018to 1 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
University hospital of Copenhagen, Rigshospitalet
Copenhagen, 2100
About this study
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)
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.
Read more
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.
Read the 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.
- Conditions
- High-grade Glioma
- Being tested
- Family and Network Consultations
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family and Network ConsultationsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Family and Network Consultations |
What is being measured
The primary outcome is the main question the study is designed to answer.
The experiences from participation in Family and network consultations (FNC)
Interviews seek the perspectives on the life situation related to the participation of FNC
Measured: At week 50 to 52
Secondary outcomes (7)
Change in the perceived Caregiver Burden Scale over time (only caregivers)
Self-reported caregiver burdens. The changes in frequencies will be calculated. No rating scale The scores of the 22 items of the Caregiver Burdenscale will be added together to produce the five sub-scales. The overall mean caregiver burden will be divided into three groups: low burden (1.00-1.99), medium burden (2.00-2.99) and high burden (3.00-4.00).
Measured: 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)
The self-reported prevalence and severity of depressive symptoms over time. The changes will be presented as separate scores for depressive symptoms.
higher scores indicating greater likelihood of depression or anxiety.
Measured: 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)
The self-reported prevalence and severity of anxiety over time. The changes will be presented as separate scores for depressive symptoms.
higher scores indicating greater likelihood of depression or anxiety.
Measured: 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)
Changes in Support from nurses. No rating scale.
Measured: 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)
Changes in Family Functioning. No rating scale.
Measured: At week 1-2, week 8-10, week 28-30 and week 50-52
The prevalence of symptoms over time will be measured by the M.D. Anderson Symptom Inventory-Brain Tumour Module
Changes in Symptoms will be reported. Each symptom is rated on a 0-10 scale (0 = ''not present'' and 10 = ''as bad as you can imagine'') over the past 24 hours. Six interference items assessing symptom-related interference in general activity, mood, work (including work around the house), relations with other people, walking, and enjoyment of life also are included in the MDASI. Each interference item is rated on a 0e10 scale (0 = ''did not interfere'' and 10 = ''interfered completely'') over the past 24 hours.
Measured: At week 1-2, week 8-10, week 28-30 and week 50-52
The quality of life will be measured by The Functional Assessment of Cancer Therapy-Brain (FACT-Br)
The self-reported quality of life related to brain cancer is measured by FACT-G. It comprises 4 sub-scales: physical well-being (PWB), social/family well-being (SWB), emotional well-being (EWB) and functional wellbeing (FWB), on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). Moreover, the brain cancer sub-scale (BrCS) reflects issues specific for brain cancer. The highest possible score is 28 for the PWB, SWB and FWB subscales, 24 for the EWB subscale and 184 for the BrCS. FACT-Br total score is the sum of the 4 sub-scales (of the core instrument). The FACT-G total score provides a summary of the overall HRQOL across the group of patients [range 0-108] and the FACT-Br Trial Outcome Index [range 0-132] is a summary index of physical/functional outcomes. The higher the score, the better HRQOL.
Measured: At week 1-2, week 8-10, week 28-30 and week 50-52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2018
- Study start9 Apr 2018
- Primary completion1 Jul 2020
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for High-grade GliomaStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- The Novo Nordic Foundation
- Responsible party
- Principal investigator, Karin Piil, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03458312
- Sponsor's protocol ID
- CARES
- Acronym
- CARES
- Status last verified
- Nov 2023
- First submitted
- 5 Jan 2018
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34286624
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03458312
- Acronym / sponsor ID
- CARES / CARES
- Conditions
- High-grade Glioma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- The Novo Nordic Foundation
- Study start
- 9 Apr 2018 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 8 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Family and Network ConsultationsIntervention: FNC IG will receive four family consultations over 52 weeks relying on the Calgary model and Patient-reported outcome on symptom management and concerns. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- -
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family and Network ConsultationsFamily 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. | Behavioural | Family and network consultations |
Primary outcome
The experiences from participation in Family and network consultations (FNC)
Time frame: At week 50 to 52
Interviews seek the perspectives on the life situation related to the participation of FNC
7 secondary outcomes
Change in the perceived Caregiver Burden Scale over time (only caregivers)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: At week 1-2, week 8-10, week 28-30 and week 50-52
The prevalence of symptoms over time will be measured by the M.D. Anderson Symptom Inventory-Brain Tumour Module
Time frame: At week 1-2, week 8-10, week 28-30 and week 50-52
The quality of life will be measured by The Functional Assessment of Cancer Therapy-Brain (FACT-Br)
Time frame: At week 1-2, week 8-10, week 28-30 and week 50-52
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Derived from this study: PubMed 34286624Piil 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family and Network Consultations in people with High-grade Glioma, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The experiences from participation in Family and network consultations (FNC) (time frame: At week 50 to 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03458312, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.