Cognition in Older Adults With Cancer Receiving Systemic Anti-Cancer Therapy (CORreCT)

February 25, 2026 updated by: Prof Andrew Davies, Our Lady's Hospice and Care Services

Evaluating Cognitive Trajectories in Older Adults With Cancer

The majority of cancer diagnoses occur in adults age 65 years and over. This population is also rapidly expanding. There is a growing need for increased understanding about the potential impact of various newer therapies on common geriatric impairments in this group.

The aim of this study is to examine how feasible it is to carry out a study of cognitive function in older adults (age 65+) who are newly commencing anti-cancer treatments, specifically 'immune checkpoint inhibitor' therapy, over time. Participants in the study undergo four tests of memory and concentration every six weeks for a six month period. Additionally, the researcher will gather information about the participants' non-cancer therapy medications, physical and psychological symptoms, day to day functioning and any changes to these factors over time.

The purpose of the study is to examine a) recruitment, retention and engagement of participants to study procedures; b) to gather preliminary information about cognitive function in older adults commencing immune checkpoint inhibitor treatments and potential associations with cognitive decline over time.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

Despite cognitive concerns being commonly described by many patients with cancer, the majority of literature focuses on the impact of chemotherapy and more recently, hormone therapies, on cognitive function. Immune checkpoint inhibitors have revolutionised the management of many cancer types, and their indications are continuing to expand. There is insufficient evidence in the literature regarding the impact of therapy on cognitive function, and particularly in older adult age groups, who may be more susceptible to the cognitive effects of treatments.

Research Hypothesis:

A significant proportion of older adults receiving ICIs have cognitive impairment at the time of cancer diagnosis and that cognition deteriorates in this cohort of adults over the course of their illness due to many factors.

Aim:

To evaluate trajectories of cognitive decline in older adults with cancer commencing ICI therapy over time and to examine associated factors which may influence the trajectory of cognitive decline in this population.

Study Design:

Feasibility Prospective Observational Study

Methodology:

Adults age 65+, newly commencing immune checkpoint inhibitor therapy recruited to this study undergo six-weekly assessments for a six month period. Each assessment includes a commonly used screening tool for mild cognitive impairment, examining global cognition - the Montreal Cognitive Assessment (MoCA); supplemented with 3 neuropsychological tests evaluating verbal learning and memory (Hopkins Verbal Learning Test - Revised), executive function (Controlled Oral Word Association Test) and executive function & processing speed (Trail-Making Test part A&B). These supplementary tests have been recommended by the International Cognition in Cancer Task force as minimum neuropsychological tests that should be included to homogenise research in this field.

Additional data is collected per participant regarding: education status, frailty status, performance status, non-cancer therapy prescriptions, physical and psychological symptoms, recent falls and hospitalisations.

The target recruitment sample is 30 patients, as this is a feasibility study.

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
    • Dublin
      • Dublin, Dublin, Ireland, D09HP89
        • St. James's Hospital, Dublin
      • Dublin, Dublin, Ireland, D09HP89
        • St. Vincent's University Hospital, Dublin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults age 65 years and over, newly commencing immune checkpoint inhibitor therapy for cancer.

Description

Inclusion Criteria:

  • Age 65 years and over
  • Newly commencing immune checkpoint inhibitor therapy (either monotherapy, dual therapy or in combination with other anti-cancer therapies)

Exclusion Criteria:

  • Unable to complete/engage in study assessment procedures
  • Unable to provide informed consent
  • Previous ICI therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Participant Group
Older adults (age 65 years and over) newly commencing immune checkpoint inhibitor therapy for cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment
Time Frame: From recruitment start date (May 2024) to recruitment end date (December 2025) (18 months)
25% of those given a Patient Information Leaflet during the recruitment period (18 months i.e. from May 2024 to December 2025) consent to the study procedures and enter the study
From recruitment start date (May 2024) to recruitment end date (December 2025) (18 months)
Retention
Time Frame: 3 months from individual participant study commencement date
50% who are still on treatment complete the 3-month assessment (primary endpoint)
3 months from individual participant study commencement date
Adherence/Engagement
Time Frame: 3 months from individual participant study start date
75% of cognitive tests are completed up to and including the 3-month timepoint
3 months from individual participant study start date
Adherence/Engagement
Time Frame: 3 months from individual study participant start date
75% of assessments are completed within 10 days of the 6-weekly timepoint
3 months from individual study participant start date

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exploratory Primary Endpoint
Time Frame: Following completion of primary endpoint (3 months)

The primary (exploratory) endpoint will be development or worsening of cognitive impairment at 3 months as defined by MOCA cut-offs for mild, moderate and severe cognitive impairment.

Age, education and sex-matched participant MOCA results from the Irish Longitudinal Study of Ageing (TILDA) will be used to provide 2 comparator groups in the analysis: a) age and sex-matched participants without cancer and b) age and sex-matched participants with cancer (i.e. an active cancer diagnosis or a diagnosis of cancer within 5 years prior to wave 6)
Following completion of primary endpoint (3 months)
Exploratory Secondary Endpoints
Time Frame: From baseline assessment (T0) to 6-month assessment (T4) i.e. at each 6-weekly assessment for a 6 month period from the time of baseline assessment.
Development or worsening of cognitive impairment (based on MOCA score) at all study time points (see above). Cognitive impairment is defined as a MOCA score of <26/30 based on the MoCA validation study. A change in MOCA score of 4 points or more indicates clinically significant change for an individual participant.
From baseline assessment (T0) to 6-month assessment (T4) i.e. at each 6-weekly assessment for a 6 month period from the time of baseline assessment.
Exploratory Secondary Endpoints
Time Frame: At primary endpoint (i.e. 3 months from time of study entry for each individual participant) (T2)
Correlation between cognition (MOCA score 0-30) and ECOG-PS (score 0-4)
At primary endpoint (i.e. 3 months from time of study entry for each individual participant) (T2)
Exploratory Secondary Endpoints
Time Frame: At primary endpoint (i.e. 3 months from time of study entry for each individual participant) (T2)
Correlation between cognition (MOCA score 0-30) and cancer stage (metastatic vs. non metastatic disease)
At primary endpoint (i.e. 3 months from time of study entry for each individual participant) (T2)
Exploratory Secondary Endpoints
Time Frame: At primary endpoint (i.e. 3 months from time of study entry for each individual participant) (T2)
Correlation between cognition (MOCA score 0-30) and physical symptoms (MSAS-SF physical subscale score)
At primary endpoint (i.e. 3 months from time of study entry for each individual participant) (T2)
Exploratory Secondary Endpoints
Time Frame: At primary endpoint (i.e. 3 months from time of study entry for each individual participant) (T2)
Correlation between cognition (MOCA score 0-30) and psychological symptoms (MSAS-SF psychological subscale score)
At primary endpoint (i.e. 3 months from time of study entry for each individual participant) (T2)
Exploratory Secondary Endpoints
Time Frame: At primary endpoint (i.e. 3 months from time of study entry for each individual participant) (T2)
Correlation between polypharmacy (5 or more medications) and cognition (MOCA score 0-30)
At primary endpoint (i.e. 3 months from time of study entry for each individual participant) (T2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Our Lady's Hospice and Care Services

Collaborators

St Vincent's University Hospital, Ireland
University of Dublin, Trinity College
St. James's Hospital, Ireland

Investigators

  • Principal Investigator: Andrew Davies, MBBS MSc MD, Our Lady's Hospice and Care Services
  • Principal Investigator: Amanda Lavan, MB, BCh, BAO, FRCPI, BSc, MSc, Mercer's Institute for Successful Ageing, St. James's Hospital, Dublin 8

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 21, 2024

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

January 6, 2026

First Submitted That Met QC Criteria

February 6, 2026

First Posted (Actual)

February 13, 2026

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 25, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 100

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Arab Emirates

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe