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.
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
30
St. James's Hospital, Dublin
Dublin, Dublin, Ireland
St. Vincent's University Hospital, Dublin
Dublin, Dublin, Ireland
Recruitment
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
Time frame: From recruitment start date (May 2024) to recruitment end date (December 2025) (18 months)
Retention
50% who are still on treatment complete the 3-month assessment (primary endpoint)
Time frame: 3 months from individual participant study commencement date
Adherence/Engagement
75% of cognitive tests are completed up to and including the 3-month timepoint
Time frame: 3 months from individual participant study start date
Adherence/Engagement
75% of assessments are completed within 10 days of the 6-weekly timepoint
Time frame: 3 months from individual study participant start date
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