Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000545268
Ethics application status
Approved
Date submitted
16/04/2009
Date registered
7/07/2009
Date last updated
20/09/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
An observation study to measure cognitive function in patients with testicular cancer who go on to have chemotherapy after surgery compared to those who don not have chemotherapy.
Scientific title
An observation study to measure cognitive function in patients with testicular cancer who go on to have chemotherapy after surgery compared to those who don not have chemotherapy.
Secondary ID [1] 281219 0
Nil
Universal Trial Number (UTN)
Trial acronym
Chemo and Cognition
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive function 4606 0
Testicular Cancer 4862 0
Condition category
Condition code
Cancer 4903 4903 0 0
Testicular
Mental Health 237213 237213 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a national, multi-centre, observational study. The aim is to prospectively and longitudinally measure cognitive function in patients being treated and followed for testicular cancer to determine whether there is an association between changes in cognitive function and chemotherapy as compared to patients with the same cancer who do not receive chemotherapy.
Patients will complete a computerized assessment of cognitive function (CogHealth), the Cognitive Failures Questionnaire (CFQ), the Hospital Anxiety and Depression Scale (HADS) and the Functional Assessment of Chronic Illness Therapy – Fatigue questionnaire (FACIT-F) on seven occasions. Patients will be assessed before surgery and at the following intervals after surgery: 1 week, 1, 3, 6, 12 and 18 months post surgery. Patients who receive chemotherapy will be assessed before the start of treatment, 1 month post chemotherapy and 12 months post chemotherapy.
Intervention code [1] 236644 0
Not applicable
Comparator / control treatment
The aim is to prospectively and longitudinally measure cognitive function in patients being treated and followed for testicular cancer to determine whether there is an association between changes in cognitive function and chemotherapy as compared to patients with the same cancer who do not receive chemotherapy.
Control group
Active

Outcomes
Primary outcome [1] 5750 0
Change in patient cognition from baseline assessments over the period of treatment and follow-up as assessed by the standardised, computerised measure CogHealth.This change in cognitive ability will be assessed after controlling for disease and treatment-related specifics, self-perceived cognitive impairment, depression, anxiety, and fatigue.
Timepoint [1] 5750 0
Patients will be assessed before surgery and at the following intervals after surgery: 1 week, 1, 3, 6, 12 and 18 months post surgery.
For patient who will receive chemotherapy will be assessed 0-30 days before starting chemotherapy, 1 month post chemotherapy (21-60 days) and 12 months (10-14 months) post chemotherapy.
Secondary outcome [1] 241702 0
Secondary outcome measures for this study include the assessment of patient symptoms over time.
Assessments will include the following: cognitive function, self-perceived cognitive function, psychological factors, aspects of treatment over the last month and physiological factors.
Timepoint [1] 241702 0
Patients will be assessed before surgery and at the following intervals after surgery: 1 week, 1, 3, 6, 12 and 18 months post surgery.

Eligibility
Key inclusion criteria
1. Men with known or suspected testicular cancer
2. Surgery planned, or done within last two months; or surgery done more than 2 months ago and chemotherapy planned
3. Age 18 years or over
4. Patients must be fluent in English
5. Patients must give written informed consent to the study which will involve serial testing
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients who have had prior chemotherapy will be excluded from the study
2. Patients who are cognitively impaired at baseline due to psychiatric or neurological illness, dementia, head injury, substance abuse, medical illnesses or are on medication likely to cause cognitive impairment

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

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
14/11/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
154
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4788 0
Other Collaborative groups
Name [1] 4788 0
Australian and New Zealand Urogenital and Prostate (ANZUP) Cancer Trials Group
Country [1] 4788 0
Australia
Funding source category [2] 4789 0
Charities/Societies/Foundations
Name [2] 4789 0
Cancer Council (NSW, VIC, TAS, SA)
Country [2] 4789 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney
NSW 2006
Country
Australia
Secondary sponsor category [1] 4323 0
None
Name [1] 4323 0
Address [1] 4323 0
Country [1] 4323 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6836 0
Cancer Institute NSW Clinical Research Ethics Committee
Ethics committee address [1] 6836 0
Australian Technology Park
Biomedical Building
Suite 101
1 Central Avenue (off Garden Road)
EVELEIGH NSW 2015
Ethics committee country [1] 6836 0
Australia
Date submitted for ethics approval [1] 6836 0
Approval date [1] 6836 0
30/10/2007
Ethics approval number [1] 6836 0
AU RED REF 07/CIC/11
Ethics committee name [2] 6837 0
University of Sydney Human Research Ethics Committee
Ethics committee address [2] 6837 0
Level 6, Jane Foss Russell Building - G02
The University of Sydney
NSW 2006
Ethics committee country [2] 6837 0
Australia
Date submitted for ethics approval [2] 6837 0
Approval date [2] 6837 0
14/09/2006
Ethics approval number [2] 6837 0
09-2006/9428

Summary
Brief summary
The purpose of this study is to implement a national longitudinal study of cognitive impairment in men diagnosed with testicular cancer. Those who go on to have chemotherapy after surgery will be compared to those who do not have chemotherapy. Mounting evidence suggests that chemotherapy may lead to cognitive impairment in patients with cancer, such as learning, memory, and attention deficits. However, methodological limitations of previously published research raise questions about the accuracy and validity of results. The current study has been designed to minimise these methodological problems and therefore provide a more conclusive outcome regarding the effect chemotherapy has on cognitive function (a) over time, (b) with a group of patients other than breast cancer patients, (c) using an appropriate control group, (d) after controlling for known confounding factors, and (e) using an appropriate measure of cognitive function that allows easy, serial assessment. If cognitive impairment is observed in the chemotherapy group over time, as compared to the group of patients not undergoing chemotherapy, outcomes will be more conclusive, and acute versus cumulative effects can be theorised. This research on the extent of cognitive impairment post-chemotherapy has implications for informed consent and the way future clinical trials are investigated, and is especially important given that cancer survivors are living longer due to advances in medical care and may suffer long-term effects of treatment.
Trial website
http://www.ctc.usyd.edu.au/our-research/clinical-trials/oncology/urogenital-and-prostate-cancer/active-trials.aspx#2
Trial related presentations / publications
Nil.
Public notes

Contacts
Principal investigator
Name 29494 0
Address 29494 0
Country 29494 0
Phone 29494 0
Fax 29494 0
Email 29494 0
Contact person for public queries
Name 12741 0
Chemo & Cognition Trial Coordinator
Address 12741 0
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown NSW 1450
Country 12741 0
Australia
Phone 12741 0
+61 2 9562 5000
Fax 12741 0
+61 2 9562 5094
Email 12741 0
[email protected]
Contact person for scientific queries
Name 3669 0
Chemo & Cognition Trial Coordinator
Address 3669 0
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown NSW 1450
Country 3669 0
Australia
Phone 3669 0
+61 2 9562 5000
Fax 3669 0
+61 2 9562 5094
Email 3669 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseThe impact of chemotherapy on cognitive function: a multicentre prospective cohort study in testicular cancer.2020https://dx.doi.org/10.1007/s00520-019-05095-3
N.B. These documents automatically identified may not have been verified by the study sponsor.