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Cognition in Older Adults With Cancer Receiving Systemic Anti-Cancer Therapy

Evaluating Cognitive Trajectories in Older Adults With Cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07411105
Acronym
CORreCT
Enrollment
30
Registered
2026-02-13
Start date
2024-05-21
Completion date
2026-07-31
Last updated
2026-02-27

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

Conditions

Cancer, Cognition, Older Adults (65 Years and Older)

Keywords

Cognition, Cancer, Geriatric Oncology, Immune Checkpoint Inhibitors

Brief summary

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.

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.

Interventions

None listed

Sponsors

Our Lady's Hospice and Care Services
Lead SponsorOTHER
University of Dublin, Trinity College
CollaboratorOTHER
St. James's Hospital, Ireland
CollaboratorOTHER
St Vincent's University Hospital, Ireland
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
RecruitmentFrom 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
Retention3 months from individual participant study commencement date50% who are still on treatment complete the 3-month assessment (primary endpoint)
Adherence/Engagement3 months from individual participant study start date75% of cognitive tests are completed up to and including the 3-month timepoint

Countries

Ireland

Contacts

PRINCIPAL_INVESTIGATORAndrew Davies, MBBS MSc MD

Our Lady's Hospice and Care Services

PRINCIPAL_INVESTIGATORAmanda Lavan, MB, BCh, BAO, FRCPI, BSc, MSc

Mercer's Institute for Successful Ageing, St. James's Hospital, Dublin 8

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026