Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 11:54 AM
Study NCT ID:
NCT07411105
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-02-27
First Post:
2026-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognition in Older Adults With Cancer Receiving Systemic Anti-Cancer Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-05-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-25', 'studyFirstSubmitDate': '2026-01-06', 'studyFirstSubmitQcDate': '2026-02-06', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Exploratory Primary Endpoint', 'timeFrame': 'Following completion of primary endpoint (3 months)', 'description': 'The primary (exploratory) endpoint will be development or worsening of cognitive impairment at 3 months as defined by MOCA cut-offs for mild, moderate and severe cognitive impairment.\n\nAge, education and sex-matched participant MOCA results from the Irish Longitudinal Study of Ageing (TILDA) will be used to provide 2 comparator groups in the analysis: a) age and sex-matched participants without cancer and b) age and sex-matched participants with cancer (i.e. an active cancer diagnosis or a diagnosis of cancer within 5 years prior to wave 6)'}, {'measure': 'Exploratory Secondary Endpoints', 'timeFrame': '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.', 'description': 'Development or worsening of cognitive impairment (based on MOCA score) at all study time points (see above). Cognitive impairment is defined as a MOCA score of \\<26/30 based on the MoCA validation study. A change in MOCA score of 4 points or more indicates clinically significant change for an individual participant.'}, {'measure': 'Exploratory Secondary Endpoints', 'timeFrame': 'At primary endpoint (i.e. 3 months from time of study entry for each individual participant) (T2)', 'description': 'Correlation between cognition (MOCA score 0-30) and ECOG-PS (score 0-4)'}, {'measure': 'Exploratory Secondary Endpoints', 'timeFrame': 'At primary endpoint (i.e. 3 months from time of study entry for each individual participant) (T2)', 'description': 'Correlation between cognition (MOCA score 0-30) and cancer stage (metastatic vs. non metastatic disease)'}, {'measure': 'Exploratory Secondary Endpoints', 'timeFrame': 'At primary endpoint (i.e. 3 months from time of study entry for each individual participant) (T2)', 'description': 'Correlation between cognition (MOCA score 0-30) and physical symptoms (MSAS-SF physical subscale score)'}, {'measure': 'Exploratory Secondary Endpoints', 'timeFrame': 'At primary endpoint (i.e. 3 months from time of study entry for each individual participant) (T2)', 'description': 'Correlation between cognition (MOCA score 0-30) and psychological symptoms (MSAS-SF psychological subscale score)'}, {'measure': 'Exploratory Secondary Endpoints', 'timeFrame': 'At primary endpoint (i.e. 3 months from time of study entry for each individual participant) (T2)', 'description': 'Correlation between polypharmacy (5 or more medications) and cognition (MOCA score 0-30)'}], 'primaryOutcomes': [{'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', 'timeFrame': '3 months from individual participant study start date', 'description': '75% of cognitive tests are completed up to and including the 3-month timepoint'}, {'measure': 'Adherence/Engagement', 'timeFrame': '3 months from individual study participant start date', 'description': '75% of assessments are completed within 10 days of the 6-weekly timepoint'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cognition', 'Cancer', 'Geriatric Oncology', 'Immune Checkpoint Inhibitors'], 'conditions': ['Cancer', 'Older Adults (65 Years and Older)', 'Cognition']}, 'referencesModule': {'references': [{'pmid': '21354373', 'type': 'BACKGROUND', 'citation': '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': '40149265', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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.\n\nThe 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.\n\nThe 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.", 'detailedDescription': '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.\n\nResearch Hypothesis:\n\nA 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.\n\nAim:\n\nTo 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.\n\nStudy Design:\n\nFeasibility Prospective Observational Study\n\nMethodology:\n\nAdults 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.\n\nAdditional data is collected per participant regarding: education status, frailty status, performance status, non-cancer therapy prescriptions, physical and psychological symptoms, recent falls and hospitalisations.\n\nThe target recruitment sample is 30 patients, as this is a feasibility study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults age 65 years and over, newly commencing immune checkpoint inhibitor therapy for cancer.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 65 years and over\n* Newly commencing immune checkpoint inhibitor therapy (either monotherapy, dual therapy or in combination with other anti-cancer therapies)\n\nExclusion Criteria:\n\n* Unable to complete/engage in study assessment procedures\n* Unable to provide informed consent\n* Previous ICI therapy'}, 'identificationModule': {'nctId': 'NCT07411105', 'acronym': 'CORreCT', 'briefTitle': 'Cognition in Older Adults With Cancer Receiving Systemic Anti-Cancer Therapy', 'organization': {'class': 'OTHER', 'fullName': "Our Lady's Hospice and Care Services"}, 'officialTitle': 'Evaluating Cognitive Trajectories in Older Adults With Cancer', 'orgStudyIdInfo': {'id': '100'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participant Group', 'description': 'Older adults (age 65 years and over) newly commencing immune checkpoint inhibitor therapy for cancer'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D09HP89', 'city': 'Dublin', 'state': 'Dublin', 'country': 'Ireland', 'facility': "St. James's Hospital, Dublin", 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'zip': 'D09HP89', 'city': 'Dublin', 'state': 'Dublin', 'country': 'Ireland', 'facility': "St. Vincent's University Hospital, Dublin", 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}], 'overallOfficials': [{'name': 'Andrew Davies, MBBS MSc MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Our Lady's Hospice and Care Services"}, {'name': 'Amanda Lavan, MB, BCh, BAO, FRCPI, BSc, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Mercer's Institute for Successful Ageing, St. James's Hospital, Dublin 8"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Our Lady's Hospice and Care Services", 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Dublin, Trinity College', 'class': 'OTHER'}, {'name': "St. James's Hospital, Ireland", 'class': 'OTHER'}, {'name': "St Vincent's University Hospital, Ireland", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Palliative Medicine', 'investigatorFullName': 'Prof Andrew Davies', 'investigatorAffiliation': "Our Lady's Hospice and Care Services"}}}}