ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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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

25/09/2024

Date data sharing statement initially provided

25/09/2024

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]

ANZUP Clinical Trials Group (Lead collaborative group)

Universal Trial Number (UTN)

Trial acronym

Chemo and Cognition

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Cognitive function

Testicular Cancer

Condition category

Condition code

Cancer

Testicular

Mental Health

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]

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]

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]

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]

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]

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?

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

Completed

Date of first participant enrolment

Anticipated

14/11/2006

Actual

14/11/2006

Date of last participant enrolment

Anticipated

Actual

1/07/2012

Date of last data collection

Anticipated

Actual

27/10/2013

Sample size

Target

154

Accrual to date

Final

145

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Other Collaborative groups

Name [1]

Australian and New Zealand Urogenital and Prostate (ANZUP) Cancer Trials Group

Address [1]

Australian and New Zealand Urogenital and Prostate (ANZUP) Cancer Trials Group and National Health and Medical Reseach Council (NHMRC) Clinical Trials Centre NHMRC Clinical Trials Centre Locked Bag 77 Camperdown NSW 1450

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Cancer Council (NSW, VIC, TAS, SA)

Address [2]

Cancer Council Australia NationalOffice
Level 1, 120 Chalmers St
Surry Hills NSW 2010

Country [2]

Australia

Primary sponsor type

University

Name

The University of Sydney

Address

The University of Sydney
NSW 2006

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Cancer Institute NSW Clinical Research Ethics Committee

Ethics committee address [1]

Australian Technology Park
Biomedical Building
Suite 101
1 Central Avenue (off Garden Road)
EVELEIGH NSW 2015

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

30/10/2007

Ethics approval number [1]

AU RED REF 07/CIC/11

Ethics committee name [2]

University of Sydney Human Research Ethics Committee

Ethics committee address [2]

Level 6, Jane Foss Russell Building - G02
The University of Sydney
NSW 2006

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

14/09/2006

Ethics approval number [2]

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

Prof Ian Olver

Address

The University of Adelaide
Adelaide, South Australia
5005 Australia

Country

Australia

Phone

+61 08 8313 5208

Fax

ian.olver@adelaide.edu.au

Contact person for public queries

Name

Chemo & Cognition Trial Coordinator

Address

NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown NSW 1450

Country

Australia

Phone

+61 2 9562 5000

Fax

+61 2 9562 5094

cogfunction@ctc.usyd.edu.au

Contact person for scientific queries

Name

Chemo & Cognition Trial Coordinator

Address

NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown NSW 1450

Country

Australia

Phone

+61 2 9562 5000

Fax

+61 2 9562 5094

cogfunction@ctc.usyd.edu.au

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

Source	Title	Year of Publication	DOI
Embase	The impact of chemotherapy on cognitive function: a multicentre prospective cohort study in testicular cancer.	2020	https://dx.doi.org/10.1007/s00520-019-05095-3

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically