Oncology

Optimizing the Measurement of Cognitive Outcomes in Oncology Clinical Trials

Cancer-related cognitive impairment impacts patient functioning across various oncology indications. An estimated 75% of all oncology patients experience changes in memory, executive function, attention, and processing speed during treatment.

Cogstate helps sponsors better evaluate cognitive impairment throughout the development lifecycle of new therapeutics in both adult and pediatric populations. We do this by providing sensitive and reliable computerized cognitive testing alongside patient reported outcomes in collaboration with our leading eCOA vendor partners.

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Optimize Cognitive Assessment with Digital Endpoints from Cogstate

Conventional paper-and-pencil cognitive assessments are often error-prone, lengthy, and require highly trained neuropsychologists for appropriate administration. This increases study costs, complicates outcome measurement, and heightens burden on patients and sites.

Cogstate’s computerized cognitive assessments offer solutions to these operational challenges:

  • Automated administration, suitable for remote testing
  • Brief, easing burden on patients and increasing completion rates
  • Automatically scored with immediate access to results
  • Culture-neutral and not limited by a subject’s level of education
  • Suitable for repeated administration

Cogstate assessments are sensitive to changes in pediatric and adult oncology patients and designed and validated to assess specific domains affected by cancer—such as attention, memory, and executive function. They’ve been leveraged to measure cognition in patients receiving a range of treatments including radiation and chemotherapy and used in all phases of drug trials.

Cognitive Batteries for Oncology

Cogstate tests are organized into study-specific batteries and are fully configurable based on the study population and research objectives. The below sample batteries offer automated administration and scoring and can be completed in approximately 20 minutes.

Cogstate Oncology Battery

Assess cognitive function in pediatric and adult subjects to study the effects of cancer and anti-cancer drugs.

Cogstate’s computerized battery of rapid, reliable, simple and sensitive tests measure the cognitive domains affected by various types of cancer, namely areas of attention, memory and executive function.

The validity of the Cogstate battery in oncology settings has been reported in the academic literature, with studies showing high acceptability and tolerability in patients with brain tumor, glioblastoma, brain metastases, metastatic melanoma, breast cancer, and men with testicular or prostate cancer. Cogstate tests have demonstrated excellent sensitivity to the cognitive impairment that occurs in oncology patients receiving a range of treatments including radiation and chemotherapy, and identification of clinically meaningful change over longitudinal assessments have been reported in response to both pharmacological or psychological therapies. Acute cognitive changes have been demonstrated in clinical trials in patients with brain metastases, breast cancer and Acute Lymphoblastic Leukemia (ALL), whilst relationships between the Cogstate tests and conventional neuropsychological and clinical rating scales in oncology have been established in pediatric and adult contexts.

Key References

Caine, J., Mehta, M., Deshmukh, S., Gondi, V., Tome, W., Kanner, A., … Kachnic, L. (2014). CogState computerized memory tests in patients with brain metastases: Secondary endpoint results of RTOG 0933. Radiotherapy and Oncology, 111, S5.

Patel, S., Meier, A., Fernandez, N., Lo, T., Moore, C., & Delgado, N. (2017). Convergent and criterion validity of the CogState computerized brief battery cognitive assessment in women with and without breast cancer. The Clinical Neuropsychologist, 1-12. http://dx.doi.org/10.1080/13854046.2016.1275819

Phillips, K.-A., Ribi, K., Sun, Z., Stephens, A., Thompson, A., Harvey, V., … Bernhard, J. (2010). Cognitive function in postmenopausal women receiving adjuvant letrozole or tamoxifen for breast cancer in the BIG 1-98 randomized trial. Breast (Edinburgh, Scotland), 19(5), 388–95. http://doi.org/10.1016/j.breast.2010.03.025

Rogiers, A., Leys, C., De Cremer, J., Awada, G., Schembri, A., … & Neyns, B. (2019). Health-related quality of life, emotional burden, and neurocognitive function in the first generation of metastatic melanoma survivors treated with pembrolizumab: a longitudinal pilot study. Supportive Care in Cancer. https://doi.org/10.1007/s00520-019-05168-3

Sands, S. A., Harel, B. T., Savone, M., Kelly, K., Vijayanathan, V., Welch, J. G., … & Cole, P. D. (2017). Feasibility and baseline neurocognitive assessment using Cogstate during the first month of therapy for childhood leukemia. Support Care Cancer, 25, 449-457.

Cogstate Tests - Adult:Detection Test
Identification Test
International Shopping List Test
One Back Test
Cogstate Tests - Pediatric:Detection Test
Identification Test
One Card Learning
One Back Test
Groton Maze Learning Test
Length:Approx. 20 minutes
Administration:Standardized
Data Processing and Scoring:Automated
Application:Phase I-IV
Culture and Language Neutral:Yes

EXPLORE OUR TESTS

Types of cancer tested include:

  • Acute lymphocytic leukemia
  • Acute Myeloid/Myelogenous
  • Brain metastases
  • Breast
  • Glioblastoma
  • Melanoma
  • Multiple Myeloma
  • Multiple solid tumors
  • Pancreatic
  • Prostate
  • Small and Non-Small Cell Lung Cancer
  • Various pediatric indications

Tests have helped sponsors answer important questions such as, “Does my drug candidate…”

  • improve cognitive function due to better tumor control?
  • slow the expected rate of cognitive deterioration due to the tumor?
  • have an acceptable safety profile?
  • have more or less short and long-term neurotoxic effects than other therapies?
  • provide a “net clinical” benefit to the patient?
  • have better/worse profiles in select patient subsets?

Improve Collection of Patient Reported Outcomes in Oncology

Cogstate works with leading eCOA partners, such as ERT, to support the measurement of Patient Report Outcomes (PROs) in oncology trials. Combining these assessments with our computerized tests on a single device and operational workflow, we provide a streamlined experience for patients and sites, and a holistic view of patient functioning.

Common PROs for measuring cognitive impairment include:

  • Functional Assessment of Cancer Therapy – Cognitive Function (FACT-Cog)
  • EORTC-QLQ-C30 Cognitive functioning subscale (EORTC-CF)
  • PROMIS – Cognitive Function & Cognitive Function – Abilities
  • MD Anderson Symptom Inventory (MDASI) Symptom Library
  • PRO-CTCAE
  • QoL measures (EORTC and FACIT scales)

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Solutions for Every Stage of Your Study Development

Cogstate’s clinical trial services, coupled with innovative operational approaches, advanced analytics, and scientific consulting, help research teams draw conclusions from study data faster and with more accuracy. Learn how we can support your study:

Scientific Consulting

Computerized Cognitive Tests

Rater Training

Central Monitoring

Scale Management

Remote / At-home Testing

How can we help you optimize the measurement of brain health?

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