Clinical trial · Observational
Cognition in Older Adults With Cancer Receiving Systemic Anti-Cancer Therapy
Evaluating Cognitive Trajectories in Older Adults With Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Cognition | — | UNRESOLVED | — |
| Older Adults (65 Years and Older) | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Participant Group
- description
- Older adults (age 65 years and over) newly commencing immune checkpoint inhibitor therapy for cancer
Primary outcomes (4)
- measure
- Recruitment
- timeFrame
- From recruitment start date (May 2024) to recruitment end date (December 2025) (18 months)
- description
- 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
- measure
- Retention
- timeFrame
- 3 months from individual participant study commencement date
- description
- 50% who are still on treatment complete the 3-month assessment (primary endpoint)
- measure
- Adherence/Engagement
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDWefel 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
- BACKGROUNDHearne 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