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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12609000545268

Acronym

Chemo and Cognition

Enrollment

145

Registered

2009-07-07

Start date

2006-11-14

Completion date

2012-07-01

Last updated

2024-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Healthy volunteers

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

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

Outcome results