Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001537741
Ethics application status
Approved
Date submitted
7/12/2022
Date registered
13/12/2022
Date last updated
9/05/2024
Date data sharing statement initially provided
13/12/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Cognitive decline in cancer: A cross-sectional study
Scientific title
Cancer-related cognitive impairment: Investigating cognition, psychosocial factors, and neurogenesis biomarkers.
Secondary ID [1] 308579 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record
ACTRN12622001548729 is the follow up of this study investigating the efficacy of a cognitive training intervention.

Health condition
Health condition(s) or problem(s) studied:
cancer 328439 0
cancer-related cognitive impairment (CRCI)
 328440 0
cancer psychosocial distress 328441 0
neurodegenerative disorders 328442 0
Condition category
Condition code
Neurological 325471 325471 0 0
Neurodegenerative diseases
Cancer 325472 325472 0 0
Any cancer

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Brief name: cross-section

This observational study involves a large cross-section of non-CNS cancer patients and demographic matched healthy controls. Variables collected include cognitive performance, psychosocial functioning, medical history, apolipoprotein genotype, and peripheral plasma brain-derived neurotrophic factor (BDNF) levels.

The mode of observation will be a single 90-120 minute visit to the study clinic per participant, at a single timepoint of data collection. This is noninclusive of preliminary screening and liaising with potential participants.
Intervention code [1] 325024 0
Early Detection / Screening
Intervention code [2] 325025 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333322 0
Verbal memory, as assessed by the Hopkins Verbal Learning Test-Revised (HVLT-R).
Timepoint [1] 333322 0
Baseline.
Primary outcome [2] 333323 0
Peripheral BDNF levels, as measured by plasma assays.
Timepoint [2] 333323 0
Baseline.
Primary outcome [3] 333324 0
Attention / executive functioning, as assessed by the Trail Making Test (TMT).
Timepoint [3] 333324 0
Baseline.
Secondary outcome [1] 416638 0
Apolipoprotein genotype, as assessed by assays of peripheral blood.
Timepoint [1] 416638 0
Baseline.
Secondary outcome [2] 416639 0
Demographics, including: age, ethnicity, race, employment status, marital status, household income, highest level of education. Assessed through self-report.
Timepoint [2] 416639 0
Baseline.
Secondary outcome [3] 416640 0
Weight and height, assessed by direct measurement before psychological testing using the same digital scales and stadiometer at the clinic.
Timepoint [3] 416640 0
Baseline.
Secondary outcome [4] 416641 0
Premorbid intelligence, as assessed by the Australian National Adult Reading Test (AUSNART).
Timepoint [4] 416641 0
Baseline.
Secondary outcome [5] 416642 0
Verbal fluency, as assessed by the Controlled Oral Word Association Test (COWAT) of the Multilingual Aphasia Examination.
Timepoint [5] 416642 0
Baseline.
Secondary outcome [6] 416643 0
Auditory information processing speed, as assessed by the Paced Auditory Serial Addition Test (PASAT).
Timepoint [6] 416643 0
Baseline.
Secondary outcome [7] 416645 0
Perceived cancer-related cognitive impairment, as assessed by the Functional Assessment of Cancer Therapy - Cognition (FACT-Cog).
Timepoint [7] 416645 0
Baseline.
Secondary outcome [8] 416646 0
Depressive symptoms, as assessed by the Patient Health Questionnaire-9 (PHQ-9).
Timepoint [8] 416646 0
Baseline.
Secondary outcome [9] 416647 0
Anxiety symptoms, as assessed by the General Anxiety Disorder-7 (GAD-7).
Timepoint [9] 416647 0
Baseline.
Secondary outcome [10] 416648 0
Sleep quality, as assessed by the Pittsburgh Sleep Quality Index (PSQI)
Timepoint [10] 416648 0
Baseline.
Secondary outcome [11] 416649 0
Experienced pain severity, as assessed by the McGill Pain Questionnaire - Short Form (MPQ-SF).
Timepoint [11] 416649 0
Baseline.
Secondary outcome [12] 416650 0
Self-efficacy, as assessed by the New General Self-Efficacy Scale (NGSE).
Timepoint [12] 416650 0
Baseline.
Secondary outcome [13] 416651 0
Quality of life / subjective well-being, as assessed by the McGill Quality of Life Questionnaire - Expanded (MQOL-E).
Timepoint [13] 416651 0
Baseline.
Secondary outcome [14] 416652 0
Death anxiety, as assessed by the Death and Dying Distress Scale (DADDS).
Timepoint [14] 416652 0
Baseline.
Secondary outcome [15] 416653 0
Morale levels, as assessed by the Demoralisation Scale-II (DS-II).
Timepoint [15] 416653 0
Baseline.
Secondary outcome [16] 416654 0
Medical history, including, but not limited to: tumour details, treatment regimen, current medication, comorbidities/premorbidities, menopausal status. Assessed through obtaining medical history and direct questioning.
Timepoint [16] 416654 0
Baseline.
Secondary outcome [17] 416655 0
Lifestyle factors, such as exercise habits, weekly alcohol consumption, use of tobacco, recreational substance use. Assessed through self-report.
Timepoint [17] 416655 0
Baseline.
Secondary outcome [18] 416656 0
Working memory, as assessed by the Stroop test.
Timepoint [18] 416656 0
Baseline.

Eligibility
Key inclusion criteria
Study inclusion criteria require participants to be aged over 18 years old, currently live in Perth and Peel regions of Western Australia (or close enough), have been diagnosed with non-CNS cancer, be currently undergoing any treatment, and have a working proficiency of the English language.

To provide a comparative baseline across assessments, 20-25% of the sample will consist of healthy controls that meet all other inclusion/exclusion criteria but are cancer-naive and are not undergoing treatment.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria preclude participation of individuals with premorbid developmental / cognitive dysfunction; premorbid neurodegenerative conditions; pregnancy; and central nervous system metastases.

Enrolment in other trials may be an exclusion criterion - case by case basis.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Although the proposed analyses (detailed further on) are mostly non-parametric, a sufficiently large sample in this study is necessary to recruit eligible participants for the subsequent study, thereby ensuring adequate statistical power to assess interventional efficacy. As such, this study aims to recruit 180 participants, which includes an additional 20% to pre-emptively mitigate potential attrition effects (150 x 1.2 = 180; Hopkin et al., 2015); of this 180, 35-45 participants will be healthy controls, and the remainder will be diagnosed with cancer.


To disentangle the complex relationships within CRCI, meta-analyses advocate for sophisticated statistical modelling and machine learning (Santos & Pyter, 2018; Seigers & Fardell, 2011; Wefel et al., 2015). As such, the proposed research will conduct three different algorithms for the main analysis, and the model that most validly represents the data for each study will be selected. It is not uncommon to test models against each other in machine learning research; this method has also been adopted by CRCI studies (e.g., Zhou et al., 2021). The proposed models are random forest regression (RFR), support vector machine (SVM), and least absolute shrinkage and selection operator (LASSO) logistic regression. To provide comparative benchmarks, basic logistic/hierarchical regressions will be run with variables mirroring the ones evinced as significant by the machine learning counterparts. The predictive utility of the machine learning models will be assessed by comparing error rate when testing the validation sample, as well as percentage of variance accounted for in outcome variable. The training/validation split will be the conventional 80/20. Treatment efficacy will be assessed simply with a within subjects t-test or Mann-Whitney U-test.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
27/02/2023
Actual
3/11/2023
Date of last participant enrolment
Anticipated
1/12/2024
Actual
Date of last data collection
Anticipated
20/12/2024
Actual
Sample size
Target
200
Accrual to date
38
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 312829 0
University
Name [1] 312829 0
Curtin University
Country [1] 312829 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Kent St, Bentley 6102, Western Australia
Country
Australia
Secondary sponsor category [1] 314471 0
None
Name [1] 314471 0
Address [1] 314471 0
Country [1] 314471 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312108 0
Curtin Human Research Ethics Committee
Ethics committee address [1] 312108 0
Ethics committee country [1] 312108 0
Australia
Date submitted for ethics approval [1] 312108 0
18/07/2023
Approval date [1] 312108 0
16/10/2023
Ethics approval number [1] 312108 0
HRE2023-0599

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123498 0
Mr Siddharth Ganesh
Address 123498 0
Curtin University, Kent St, Bentley WA 6102
Country 123498 0
Australia
Phone 123498 0
+61 406659735
Fax 123498 0
Email 123498 0
[email protected]
Contact person for public queries
Name 123499 0
Siddharth Ganesh
Address 123499 0
Curtin University, Kent St, Bentley WA 6102
Country 123499 0
Australia
Phone 123499 0
+61 493105286
Fax 123499 0
Email 123499 0
[email protected]
Contact person for scientific queries
Name 123500 0
Siddharth Ganesh
Address 123500 0
Curtin University, Kent St, Bentley WA 6102
Country 123500 0
Australia
Phone 123500 0
+61 406659735
Fax 123500 0
Email 123500 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Scores on cognitive and psychosocial measures; deidentified medical and demographic information; neurogenesis biomarkers data. Subsequent analyses will be made public as well.

None of this data will be identifiable.
When will data be available (start and end dates)?
Once data is obtained - no end date.
Available to whom?
Only future researchers who provide a methodologically sound proposal, at the discretion of the primary investigators and Curtin University.
Available for what types of analyses?
Meta-analyses / systematic reviews, machine learning research, CRCI research.
How or where can data be obtained?
Yet to be determined, but will need to contact primary investigators.

Siddharth Ganesh
[email protected]


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.