NCT07411105

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

Evaluating Cognitive Trajectories in Older Adults With Cancer

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Our Lady's Hospice and Care Services · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Timeline

• Start date: 2024-05-21
• Primary completion: 2026-05-31
• Completion: 2026-07-31
• First posted: 2026-02-13
• Last updated: 2026-02-27

Locations

2 sites across 1 country: Ireland