CancerCORreCTNCT07411105
Cognition in Older Adults With Cancer Receiving Systemic Anti-Cancer Therapy
An observational study of Cancer and Older Adults (65 Years and Older), run by Our Lady's Hospice and Care Services at 2 sites in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cancer, Older Adults (65 Years and Older), Cognition
- How many people
- 30 participants
- Where
- 2 sitesIreland
- Study dates
- 21 May 2024to 31 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Adults age 65 years and over, newly commencing immune checkpoint inhibitor therapy for cancer.
Who may be able to join
- Age 65 years and over
- Newly commencing immune checkpoint inhibitor therapy (either monotherapy, dual therapy or in combination with other anti-cancer therapies)
Who cannot join
- Unable to complete/engage in study assessment procedures
- Unable to provide informed consent
- Previous ICI therapy
Trial locations and contacts
2 sites in 1 country.
Ireland2 sites
St. James's Hospital, Dublin
Dublin, Dublin, D09HP89
St. Vincent's University Hospital, Dublin
Dublin, Dublin, D09HP89
About this study
Official title: Evaluating Cognitive Trajectories in Older Adults With Cancer
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.
Read the 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
- Keywords
- Cognition, Cancer, Geriatric Oncology, Immune Checkpoint Inhibitors
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participant Group | Older adults (age 65 years and over) newly commencing immune checkpoint inhibitor therapy for cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 3 months from individual participant study commencement date
Adherence/Engagement
75% of cognitive tests are completed up to and including the 3-month timepoint
Measured: 3 months from individual participant study start date
Adherence/Engagement
75% of assessments are completed within 10 days of the 6-weekly timepoint
Measured: 3 months from individual study participant start date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start21 May 2024
- Primary completion31 May 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Our Lady's Hospice and Care Services
- Sponsor type
- University, hospital or other
- Collaborators
- University of Dublin, Trinity College, St. James's Hospital, Ireland, St Vincent's University Hospital, Ireland
- Responsible party
- Principal investigator, Prof Andrew Davies, Our Lady's Hospice and Care Services
- Investigators
- Andrew Davies, MBBS MSc MD, Principal investigator, Our Lady's Hospice and Care ServicesAmanda Lavan, MB, BCh, BAO, FRCPI, BSc, MSc, Principal investigator, Mercer's Institute for Successful Ageing, St. James's Hospital, Dublin 8
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07411105
- Sponsor's protocol ID
- 100
- Acronym
- CORreCT
- Status last verified
- Feb 2026
- First submitted
- 6 Jan 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 21354373Hearne 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.
PubMed 40149265
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Cognitive Trajectories in Older Adults With Cancer
- ClinicalTrials.gov ID
- NCT07411105
- Acronym / sponsor ID
- CORreCT / 100
- Conditions
- Cancer, Older Adults (65 Years and Older), Cognition
- Keywords
- Cognition, Cancer, Geriatric Oncology, Immune Checkpoint Inhibitors
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Our Lady's Hospice and Care ServicesUniversity, hospital or other
- Collaborators
- University of Dublin, Trinity College, St. James's Hospital, Ireland, St Vincent's University Hospital, Ireland
- Study start
- 21 May 2024 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participant Group | – | –Older adults (age 65 years and over) newly commencing immune checkpoint inhibitor therapy for cancer |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Adults age 65 years and over, newly commencing immune checkpoint inhibitor therapy for cancer.
Key inclusion criteria (2 listed)
- Age 65 years and over
- Newly commencing immune checkpoint inhibitor therapy (either monotherapy, dual therapy or in combination with other anti-cancer therapies)
Key exclusion criteria (3 listed)
- Unable to complete/engage in study assessment procedures
- Unable to provide informed consent
- Previous ICI therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Recruitment
Time frame: From 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
Retention
Time frame: 3 months from individual participant study commencement date
50% who are still on treatment complete the 3-month assessment (primary endpoint)
Adherence/Engagement
Time frame: 3 months from individual participant study start date
75% of cognitive tests are completed up to and including the 3-month timepoint
Adherence/Engagement
Time frame: 3 months from individual study participant start date
75% of assessments are completed within 10 days of the 6-weekly timepoint
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Background: PubMed 21354373Wefel 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.
- Background: PubMed 40149265Hearne 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.
- Individual participant dataSharing planned: Undecided
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Davies, MBBS MSc MD principal investigator
Our Lady's Hospice and Care Services
Amanda Lavan, MB, BCh, BAO, FRCPI, BSc, MSc principal investigator
Mercer's Institute for Successful Ageing, St. James's Hospital, Dublin 8
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Older Adults (65 Years and Older), run by Our Lady's Hospice and Care Services at 2 sites in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (time frame: From recruitment start date (May 2024) to recruitment end date (December 2025) (18 months)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07411105, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.