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Trial registered on ANZCTR


Registration number
ACTRN12620000481976
Ethics application status
Approved
Date submitted
17/12/2019
Date registered
16/04/2020
Date last updated
16/04/2020
Date data sharing statement initially provided
16/04/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
COPING: COgnitive impairment in People with glioma and distress in the INformal care-Givers
Scientific title
Cognitive impairment in People with glioma and distress in the informal care-givers: Piloting the ARCS Assessment tool.
Secondary ID [1] 299677 0
Nil known
Universal Trial Number (UTN)
Trial acronym
COPING
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glioma 315027 0
Cognitive Impairment 316012 0
Condition category
Condition code
Cancer 313357 313357 0 0
Brain
Neurological 314286 314286 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
As cancer progression is almost inevitable in High-Grade Gliomas (HGG), both patients and their informal caregivers have little time for adaptation to these neurological deficits and with these deficits often rapidly worsening with disease progression. Assessment of patients by their multidisciplinary health care team can help detect and address neurological and cognitive deficits. However, healthcare professionals’ time and resources are limited to complete conventional neuropsychological testing which typically requires one to two hours. To correctly identify and respond to cognitive deficits, a simple and brief assessment process is urgently needed.

This study aims to assess the feasibility of a simple, cost-effective and validated, self-administered cognitive assessment Audio Recorded Cognitive Screen (ARCS; www.cognitionhealth.com) for use with brain cancer patients. Brain cancer patients’ cognitive function will be assessed at two to three critical time-points in treatment using ARCS in clinic settings. The study will examine the association between cognitive impairment in patients and the need for hospitalisation and overall survival. Associations between cognitive impairment in patients with caregiver burden and mastery will also be assessed as a secondary study aim.

ARCS is administered to unsupervised patients via an audio device, with questions completed using pen and paper. The ARCS screening assessment consists of items that tests memory, verbal fluency, language, attention and visuospatial function. The screening is focused on cognition. Brief questions about the screening tool acceptability (such as instructions) are completed by participants immediately after ARCS. On average, the test requires approximately 34 minutes to complete and participants’ score are minimally impacted by writing speed, hearing difficulties, or difficulties with survey instructions. The scoring will completed by cancer care coordinators using a customised Excel spreadsheet that provides both domain and global scores that are adjusted according to respondents’ age, gender, and education. The average amount of time to complete scoring is approximately 4 minutes. Once scaled, a score of 100 is considered normal cognition; a score of 78 (-1.5 standard deviations) suggests cognitive deficit and warrants clinical concern.

The screening tool will only be administered to patients at the practice who are participating in the study – individuals must meet the eligibility criteria and have interaction with cancer care coordinators who administer the tool. This may not be all newly diagnosed patients within the service.
Intervention code [1] 315942 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322081 0
The primary outcome is to assess the feasibility of a simple, cost-effective and validated, self-administered cognitive assessment Audio Recorded Cognitive Screen (ARCS; www.cognitionhealth.com) for use with brain cancer patients at two to three critical time-points in treatment using ARCS in clinic settings. Feasibility will be assessed by ARCS tool completion rates and patients’ responses to survey items on acceptability.
Timepoint [1] 322081 0
The primary time-point will be at the 2nd ARCs assessment which will occur 4-6 weeks post radiation therapy depending on appointment timing.
Secondary outcome [1] 377268 0
Secondary outcome (1) will be to examine the changes of patient cognitive decline over time as measured by changes in ARCS scores over the assessments. Specifically, this will be assessed with an ARCS score of or below 78 (-1.5 standard deviations below normative value) and subsequent decline between at least two measurement time points. A third ARCS assessment may be completed depending on patients’ treatment, cancer progression and appointments.
Timepoint [1] 377268 0
6 months post-recruitment to allow for at least two ARCs assessments to occur (options: baseline; 4-6 weeks post radiation therapy; additional screen based on coordinator preference).
Secondary outcome [2] 377269 0
Secondary outcome (2) will be patient survival rates at 6-months as assessed by patient medical records.
Timepoint [2] 377269 0
6 months post-recruitment to allow for at least two ARCs assessments to occur (options: baseline; 4-6 weeks post radiation therapy; additional screen based on coordinator preference).

Secondary outcome [3] 381170 0
Secondary outcome (3) will be patient hospital admissions at 6-months as assessed by patient medical records.
Timepoint [3] 381170 0
6 months post-recruitment to allow for at least two ARCs assessments to occur (options: baseline; 4-6 weeks post radiation therapy; additional screen based on coordinator preference).
Secondary outcome [4] 381171 0
Secondary outcome (4) to assess caregiver burden using the Zarit Burden Interview Short Version.

The Zarit Burden Interview Short Version tool is a 12 item tool with items addressing Caregiver Burden including personal strain and role strain. This tool has been validated in adults with cognitive impairment.

Timepoint [4] 381171 0
Secondary timepoint (4) 6 months post-recruitment to allow for at least two ARCs assessments of patients to occur (options: baseline; 4-6 weeks post radiation therapy; additional screen based on coordinator preference) and completion of two caregiver surveys (completed by informal caregivers concurrent to patient ARCS assessment).
Secondary outcome [5] 381172 0
Secondary outcome (5) will be to assess caregiver mastery in patients’ informal caregivers using the Caregiver Reaction Assessment (CRA).

The CRA is a well-validated tool previously administered to glioblastoma patient groups by the National Cancer Institute. The tool includes 24 items across 5 scales spanning the broad range of impacts on: caregivers’ self-esteem; relational deprivation; caregivers’ schedule including job conflicts; competence; family beliefs.

Timepoint [5] 381172 0
Secondary timepoint (5) will be 6 months post-recruitment to allow for at least two ARCS assessments of patients to occur (options: baseline; 4-6 weeks post radiation therapy; additional screen based on coordinator preference) and completion of two caregiver surveys (completed by informal caregivers concurrent to patient ARCS assessment).

Eligibility
Key inclusion criteria
Patients:
1. Aged 18 years or older
2. Have received a confirmed diagnosis of low- or high- grade glioma or glioblastoma
4. Have at least two appointments within a six-month time frame at the study site(s)
5. English proficient

For patients interested in the study, members of the participant’s healthcare team will make a decision with the patient using their best professional judgement about the patient’s capacity to give free and informed consent to this study.

Caregivers: A caregiver does not need to consent to participate for a patient to participate. These participants must be:
1. Aged 18 years or older
2. English Proficient
3. Be planning to attend at least two subsequent appointments in a six-month time frame at the study site(s) with an individual with a confirmed diagnosis of low- or high- grade glioma or glioblastoma
No criteria regarding relationship type (ie: spouse, sibling, adult child) is included.

In order for caregivers to participate, a patient must also participate.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Under the age of 18 years
2. Not English Proficient
3. Cognition is too poor to provide informed consent as deemed by patient’s health care team
4. No confirmed diagnosis

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The primary study aim is to test the feasibility and acceptability of cognitive self-assessment with patients. This aim will be determined based on completion rates and patients’ survey responses (primary outcome) at the second ARCS assessment (4-6 months post radiation therapy). The number of patients who declined to participate will also be reported.

Aim 1 is to examine changes in cognition over time. The proportion of participants who have an ARCS score of or below 78 (-1.5 standard deviations below normative value) and subsequent decline between at least two measurement time points will be reported.

Aim 2 is to examine if cognitive decline is associated with survival. This outcome will be assessed through logistic regression analysis with the ARCS global scores as the independent variable of interest and rates of survival as the dependent variable.

Aim 3 is to examine if cognitive decline is associated with hospitalisation. This outcome will be assessed through logistic regression analysis with the ARCS global scores as the independent variable of interest and rates of hospitalisation as the dependent variable.

Aim 4 is to examine if patient cognitive decline is associated with caregiver burden in informal caregivers at 4-6 weeks post-radiation therapy. This outcome will be assessed using multivariate analysis with Zarit Burden Interview scores; this relationship will be mediated by caregiving competency (measured by the Caregiver Mastery Scale). Other potential mediators will be examined such as: age; gender; relation to the patient; highest level of education completed; financial loss; health insurance; and Patient Health Questionnaire-4 (depression and anxiety). These variables are selected based on previous research demonstrating increased burden according to age, spousal relationship, gender, education, pre-existing financial strain, and a lack of social supports.

Aim 5 is to examine if patient cognitive decline is associated with caregiver mastery informal caregivers at 4-6 weeks post-radiation therapy. This outcome will be assessed using multivariate analysis with Caregiver Reaction Assessment (CRA) scores; this relationship will be mediated by caregiving competency (measured by the Caregiver Mastery Scale). Other potential mediators will be examined such as: age; gender; relation to the patient; highest level of education completed; financial loss; health insurance; and Patient Health Questionnaire-4 (depression and anxiety).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 15338 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 15339 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [3] 15340 0
John Hunter Hospital - New Lambton
Recruitment postcode(s) [1] 28648 0
2065 - St Leonards
Recruitment postcode(s) [2] 28649 0
2298 - Waratah
Recruitment postcode(s) [3] 28650 0
2305 - New Lambton

Funding & Sponsors
Funding source category [1] 304152 0
Charities/Societies/Foundations
Name [1] 304152 0
Mark Hughes Foundation Sutton Family Brain Cancer Research Project Grant
Address [1] 304152 0
PO Box 417, Hamilton NSW 2303
Country [1] 304152 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive, Callaghan, 2308, NSW
Country
Australia
Secondary sponsor category [1] 304631 0
None
Name [1] 304631 0
Address [1] 304631 0
Country [1] 304631 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304632 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 304632 0
Locked Bag 1, New Lambton NSW 2305
Ethics committee country [1] 304632 0
Australia
Date submitted for ethics approval [1] 304632 0
06/09/2019
Approval date [1] 304632 0
13/09/2019
Ethics approval number [1] 304632 0

Summary
Brief summary
The study aims to assess the feasibility and acceptability of a cognitive assessment tool for brain cancer patients. The study will examine if the tool is acceptable to patients and health professionals and could be included in routine health care practices. The study will also look at the relationship between cognitive decline in patients, hospital use, and the impact on caregivers.

Who is it for?
You may be eligible to join this study if you are aged 18 years or older and have been diagnosed with Brain cancer (Glioma/Glioblastoma)

Study details
This study will involve a questionnaire about cognitive function. Participants will write down their responses to the verbal questions. The questionnaire will be administered two or three times during the study at regular clinic visits. Carers can also answer questions about their experiences caring for someone with brain cancer.
It is hoped this study can provide greater insight to the cognitive challenges of people with brain cancer and the experiences of their carers. The information gathered in this study will help inform future studies regarding the acceptability of the screening tools.

Hypotheses:
Hypothesis 1: Patients will report the ARCS tool is acceptable (i.e. over 75% of patients will report willingness to complete a similar test in the future), and will record assessment completion rates over 90% at both time-points.

Hypothesis 2: A high proportion of participants (>60%) will show cognitive decline over time as measured by changes in ARCS scores between at least two measurement time points.

Hypothesis 3: An ARCS score of or below 78 (-1.5 standard deviations below normative value) and subsequent decline between two measurement time points will be significantly associated with decreased survival at 6-months.

Hypothesis 4: An ARCS score of or below 78 (-1.5 standard deviations below normative value) and subsequent decline between two measurement time points will be significantly associated with increased logistic odds of hospitalisation at 6-months.

Hypothesis 5: An ARCS score of or below 78 (-1.5 standard deviations below normative value) and subsequent decline between two measurement time points will be significantly associated with survival at 6-months.

Hypothesis 6: ARCS score of or below 78 at either time point will significantly correspond with caregiver burden as measured by the Zarit Burden Interview Short Version. This will be mediated by caregiver competency as measured by Caregiver Mastery Scale.

Hypothesis 6: ARCS score of or below 78 at either time point will significantly correspond with caregiver burden as measured by using the Caregiver Reaction Assessment. This will be mediated by caregiver competency as measured by Caregiver Mastery Scale.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97654 0
Dr Elizabeth Fradgley
Address 97654 0
School of Medicine and Public Health, University of Newcastle, HMRI Building L4 West, University Drive, Callaghan, NSW 2308
Country 97654 0
Australia
Phone 97654 0
+61 02 40420642
Fax 97654 0
Email 97654 0
elizabeth.fradgley@newcastle.edu.au
Contact person for public queries
Name 97655 0
Dr Elizabeth Fradgley
Address 97655 0
School of Medicine and Public Health, University of Newcastle, HMRI Building L4 West, University Drive, Callaghan, NSW 2308
Country 97655 0
Australia
Phone 97655 0
+61 02 40420642
Fax 97655 0
Email 97655 0
elizabeth.fradgley@newcastle.edu.au
Contact person for scientific queries
Name 97656 0
Dr Elizabeth Fradgley
Address 97656 0
School of Medicine and Public Health, University of Newcastle, HMRI Building L4 West, University Drive, Callaghan, NSW 2308
Country 97656 0
Australia
Phone 97656 0
+61 02 40420642
Fax 97656 0
Email 97656 0
elizabeth.fradgley@newcastle.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 5880 0
Study protocol
Citation [1] 5880 0
Link [1] 5880 0
Email [1] 5880 0
Other [1] 5880 0
Type [2] 5881 0
Informed consent form
Citation [2] 5881 0
Link [2] 5881 0
Email [2] 5881 0
Other [2] 5881 0
The Informed Consent Form for Caregivers does not require caregivers to consent to medical record collection. The caregiver forms also differ from the patient ICFs as the caregiver forms do not incorporate options for cognitive decline and the varied capacity for informed consent that may be a consideration in the patient participant group.
Type [3] 5882 0
Ethical approval
Citation [3] 5882 0
Link [3] 5882 0
Email [3] 5882 0
Other [3] 5882 0
Type [4] 5883 0
Informed consent form
Citation [4] 5883 0
Link [4] 5883 0
Email [4] 5883 0
Other [4] 5883 0
The Informed Consent Form for patients differs from the Informed Consent Form for caregivers due to the difference between the two cohorts in data collection methods and the potential for patients to experience reduced capacity for consent.
The Patient Informed Consent gives permission for the research team to access their medical records (not required for caregiver participants).
The Informed Consent also take into consideration patient’s capacity to consent by:
1. Providing an opportunity for their healthcare professional to affirm their discussion with the participant and their capacity to give free and informed consent.
2. Providing an opportunity for participants to choose how their participation should be handled in the event that future cognitive decline impacts their capacity to consent later in the study.
Summary results
No Results