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Trial registered on ANZCTR


Registration number
ACTRN12616001007426
Ethics application status
Approved
Date submitted
26/07/2016
Date registered
29/07/2016
Date last updated
8/10/2019
Date data sharing statement initially provided
8/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the Impact of Androgen Deprivation Therapy on Cognition in an Australian Sample of Prostate Cancer Patients
Scientific title
Evaluating the Impact of Androgen Deprivation Therapy on Cognition in an Australian Sample of Prostate Cancer Patients
Secondary ID [1] 289759 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 299615 0
Cognitive function 299616 0
Condition category
Condition code
Cancer 299580 299580 0 0
Prostate
Mental Health 299581 299581 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
9
Target follow-up type
Months
Description of intervention(s) / exposure
Cognitive function tests
Computer based task
The Jansari assessment of Executive Functions, JEF (Copyright), is a novel, computer based virtual reality program.
In the assessment, a participant is invited to navigate around a Virtual Reality(VR) environment on a computer to complete a set of 10 listed tasks and a further 2 tasks that require creative thinking. The scenes are set in a typical office and meeting room. Participants are guided by a research team member with clear instructions given for the assessment. No prior computer knowledge or use is required. The assessment takes on average 40 minutes to complete.
Paper based tasks
Four standardised measures of executive functions have been chosen based on recommendations by the International Cognition and Cancer Task Force (Wefel et al, 2011) and previous studies in this area. They assess the domains of different executive functions that can be evaluated against standardised norms. The tests comprise of the following:

*Hopkins Verbal Learning Test – Revised (HVLT-R): 5-10 minutes with a 25 minute delay
HVLT-R measures verbal memory. Participants are presented with 12 words over 3 immediate learning trials and 1 delayed recall trial followed by a recognition list task.

*Trail Making Test (TMT) A: 1-2 minutes
TMT A measures sustained attention and working memory. It requires a participant to connect numbered circles consecutively.

*Trail Making Test (TMT ) B: 1-3 minutes
TMT B measures an executive function - cognitive flexibility. Participants are asked to connect alternating numbers and letters in sequence.

*Controlled Oral Word Association test (COWA): 3-5 minutes
COWA is a measure of speeded lexical fluency using letters that correspond to specified word frequencies in the English language.

Participants’ estimation of pre-morbid intelligence levels will be assessed by the following standardised test
National Adult Reading Test (NART)

The following Patient Reported Outcome (PRO) questionnaires will be used in this study to review impact of cognitive function on QoL:
1. EORTC QLQ-C30
2. EORTC PR-25
3. Hospital Anxiety and Depression Scale (HADS)
4. Fatigue Symptom Inventory (FSI)
5. Cognitive Failure Questionnaire (CFQ)
6. Cognitive Failure Questionnaire-for-others (CFQ-O)

Who will deliver the intervention
Assessments will be conducted by the researchers (trained to perform assessments)

The mode of delivery
Face to face individual assessments

The number of times the intervention will be delivered and over what period of time
Two time points-baseline and at 9 months.
Duration of assessments 45mins to 80minutes

Location
Cancer care centre clinic
Intervention code [1] 295409 0
Not applicable
Comparator / control treatment
Assessments to be carried out in
Group1 -ADT(patients on Androgen Deprivation Therapy)
Group2-nADT(patients not on Androgen Deprivation Therapy)
Control group
Active

Outcomes
Primary outcome [1] 299054 0
Cognitive function, as assessed by cognitive assessments
Jansari assessment of Executive Functions
Hopkins Verbal Learning Test – Revised (HVLT-R)
Trail Making Test (TMT) A
Trail Making Test (TMT) B
Controlled Oral Word Association test (COWA)
Timepoint [1] 299054 0
9 months from baseline
Secondary outcome [1] 326037 0
The impact of cognitive function on quality of life.
The following Patient Reported Outcome (PRO) questionnaires will be used
1. EORTC QLQ-C30
2. EORTC PR-25
3. Hospital Anxiety and Depression Scale (HADS)
4. Fatigue Symptom Inventory (FSI)
5. Cognitive Failure Questionnaire (CFQ)
6. Cognitive Failure Questionnaire-for-others (CFQ-O)
Timepoint [1] 326037 0
9 months from baseline

Eligibility
Key inclusion criteria
*Gender eligible for study: male
*Prostate cancer diagnosis
*MMSE > 24
*ECOG status between 0 – 1
*Speak and read English


ADT group
* Planned to commence ADT within 1 month

nADT group
* No prior or current ADT
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Participants are not eligible to participate on the following basis:

*Commenced on ADT
*Prior ADT
*Previous or current chemotherapy treatment
*Previous or current severe psychiatric history as defined by
- A diagnosed mental illness involving psychosis
- Hospitalisation for mental health difficulties
*Current diagnosis of major depressive episode or an anxiety disorder
*Previous or current neurological difficulties e.g. Seizures or stroke
*Previous or current significant heart disease e.g. Myocardial infarction, Congestive Cardiac Failure
*History of brain cancer
*Patients with a past history of cancer in the 5 years before registration except for the following: Patients with squamous or basal cell carcinoma of the skin that has been effectively treated.
*Life expectancy less than 1 year
*Prior orchidectomy
*Participation in other projects involving cognitive testing.

Study design
Purpose
Psychosocial
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Statistical Analyses

A sample of 45 participants per group (90 in total) is sufficient to find a 30% difference in the proportion of participants that are cognitively impaired between the control and ADT groups assuming 10% of participants in the control group are cognitively impaired, 33% loss to follow up at 9 months, 80% power and 5% significance.

Chi-square analysis will be used at the second time point to determine whether there is a difference in the proportions of cognitively impaired participants between the control and ADT groups.

A Generalised Estimating Equation will be used to provide an odds ratio of the number of participants in the ADT group who are cognitively impaired compared to the nADT group, with a time by group interaction whilst adjusting for fatigue. The criteria for cognitive impairment will be defined using the International Cognition and Cancer Task Force and is as follows:
- -1.5 S.D. below the mean on 2 cognitive tests
- -2 S.D. below the mean on 1 cognitive test

For this study, the 8 constructs of JEF(Copyright) will be treated as one set of tests and the 4 paper based tests (HVLT-R, TMT A & B, COWA) will be treated as another set of tests.

Participants’ individual performance on the cognitive tests will be evaluated by a repeated measures ANOVA.

Recruitment
Recruitment status
Suspended
Date of first participant enrolment
Anticipated
31/10/2016
Actual
24/11/2016
Date of last participant enrolment
Anticipated
15/06/2018
Actual
23/05/2017
Date of last data collection
Anticipated
15/03/2019
Actual
Sample size
Target
90
Accrual to date
39
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 6264 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [2] 6265 0
Nepean Hospital - Kingswood
Recruitment postcode(s) [1] 13700 0
2560 - Campbelltown
Recruitment postcode(s) [2] 13701 0
2747 - Kingswood

Funding & Sponsors
Funding source category [1] 294142 0
Hospital
Name [1] 294142 0
Nepean Cancer Care Centre, Nepean Hospital
Country [1] 294142 0
Australia
Primary sponsor type
Government body
Name
Nepean and Blue Mountains Local Health District
Address
Nepean Hospital
P O Box 63
Penrith, NSW 2751
Country
Australia
Secondary sponsor category [1] 292970 0
Government body
Name [1] 292970 0
Sydney South West Local Health District
Address [1] 292970 0
Campbelltown Hospital
PO Box 149
Campbelltown, NSW 2560
Country [1] 292970 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295554 0
South Western Sydney Local Health District (SWSLHD) Human Research Ethics Committee (EC00136)
Ethics committee address [1] 295554 0
Research and Ethics Office
Locked Bag 7103
Liverpool BC, NSW 1871
Ethics committee country [1] 295554 0
Australia
Date submitted for ethics approval [1] 295554 0
25/07/2016
Approval date [1] 295554 0
12/09/2016
Ethics approval number [1] 295554 0

Summary
Brief summary
The primary purpose of this study is to evaluate the impact of androgen deprivation therapy (ADT) on cognitive function in men with prostate cancer.

Who is it for?
You may be eligible to enroll in this study if you are aged 18 or over and have been diagnosed with prostate cancer for which you have received no ADT previously. You must either be scheduled to begin ADT in the next month, or have no ADT planned.

Study details
All participants in this study will complete a screening questionnaire and then if eligible, an
assessment session at enrolment and again 9 months later. Each assessment session is expected to last 45-80 minutes and will involve computer-based testing, pen and paper tasks, plus a number of paper questionnaires.

It is hoped that this study will improve understanding of the cognitive effects of ADT in men with prostate cancer.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67714 0
Ms Mey Teoh
Address 67714 0
Macarthur Cancer Therapy Centre
PO Box 149
Campbelltown, NSW 2560
Country 67714 0
Australia
Phone 67714 0
+61 2 4634 4300
Fax 67714 0
+61 2 4634 4311
Email 67714 0
[email protected]
Contact person for public queries
Name 67715 0
Mey Teoh
Address 67715 0
Macarthur Cancer Therapy Centre
PO Box 149
Campbelltown, NSW 2560
Country 67715 0
Australia
Phone 67715 0
+61 2 4634 4300
Fax 67715 0
+61 2 4634 4311
Email 67715 0
[email protected]
Contact person for scientific queries
Name 67716 0
Mey Teoh
Address 67716 0
Macarthur Cancer Therapy Centre
PO Box 149
Campbelltown, NSW 2560
Country 67716 0
Australia
Phone 67716 0
+61 2 4634 4300
Fax 67716 0
+61 2 4634 4311
Email 67716 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



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.