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

NCT07411105 | Active Not Recruiting DMC

• 1 other identifier: 100
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Cognition; Cancer; Geriatric Oncology; Immune Checkpoint Inhibitors

Outcome Measures

Primary Outcomes (4)

• 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

  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)

  3 months from individual participant study commencement date

• Adherence/Engagement

  75% of cognitive tests are completed up to and including the 3-month timepoint

  3 months from individual participant study start date

• Adherence/Engagement

  75% of assessments are completed within 10 days of the 6-weekly timepoint

  3 months from individual study participant start date

Other Outcomes (7)

• Exploratory Primary Endpoint

  Following completion of primary endpoint (3 months)

• Exploratory Secondary Endpoints

  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

  At primary endpoint (i.e. 3 months from time of study entry for each individual participant) (T2)

Study Arms (1)

Participant Group

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

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Our Lady's Hospice and Care Services: lead
• University of Dublin, Trinity College: collaborator
• St. James's Hospital, Ireland: collaborator
• St Vincent's University Hospital, Ireland: collaborator

Study Sites (2)

St. James's Hospital, Dublin

Dublin, Dublin, D09HP89, Ireland

Location

St. Vincent's University Hospital, Dublin

Dublin, Dublin, D09HP89, Ireland

Location

Related Publications (2)

• Wefel JS, Vardy J, Ahles T, Schagen SB. International Cognition and Cancer Task Force recommendations to harmonise studies of cognitive function in patients with cancer. Lancet Oncol. 2011 Jul;12(7):703-8. doi: 10.1016/S1470-2045(10)70294-1. Epub 2011 Feb 25.

  PMID: 21354373 BACKGROUND

• Hearne S, McDonnell M, Lavan AH, Davies A. Immune Checkpoint Inhibitors and Cognition in Adults with Cancer: A Scoping Review. Cancers (Basel). 2025 Mar 9;17(6):928. doi: 10.3390/cancers17060928.

  PMID: 40149265 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Palliative Medicine

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: February 13, 2026
• Study Start: May 21, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

IE (2)