Ignite Creation Date:
2025-12-24 @ 12:47 PM
Ignite Modification Date:
2025-12-29 @ 7:35 PM
Study NCT ID:
NCT06880861
Status:
RECRUITING
Last Update Posted:
2025-12-17
First Post:
2025-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigating Memory and Physical Activity After Cancer Treatment in Survivors of Adolescent and Young Adult Cancers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2025-03-12', 'studyFirstSubmitQcDate': '2025-03-12', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cognitive performance on Stroop task', 'timeFrame': 'Up to 4 weeks', 'description': 'Assessed using the CNS Vital Signs computerized testing platform ("brain games"). CNS Vital Signs is a computerized neuropsychological/neurocognitive assessment platform used by clinicians and researchers to objectively evaluate brain function and neurocognitive status, offering a range of tests and tools for assessment and management of various neurological and behavioral conditions.'}], 'secondaryOutcomes': [{'measure': 'Cognitive performance on Visual Memory Test', 'timeFrame': '2 weeks', 'description': 'Assessed using the CNS Vital Signs computerized testing platform ("brain games"). CNS Vital Signs is a computerized neuropsychological/neurocognitive assessment platform used by clinicians and researchers to objectively evaluate brain function and neurocognitive status, offering a range of tests and tools for assessment and management of various neurological and behavioral conditions.'}, {'measure': 'Cognitive performance on Verbal Memory Test', 'timeFrame': '2 weeks', 'description': 'Assessed using the CNS Vital Signs computerized testing platform ("brain games"). CNS Vital Signs is a computerized neuropsychological/neurocognitive assessment platform used by clinicians and researchers to objectively evaluate brain function and neurocognitive status, offering a range of tests and tools for assessment and management of various neurological and behavioral conditions.'}, {'measure': 'Cognitive performance on Symbol Digit Coding Test', 'timeFrame': '2 weeks', 'description': 'Assessed using the CNS Vital Signs computerized testing platform ("brain games"). CNS Vital Signs is a computerized neuropsychological/neurocognitive assessment platform used by clinicians and researchers to objectively evaluate brain function and neurocognitive status, offering a range of tests and tools for assessment and management of various neurological and behavioral conditions.'}, {'measure': 'Cognitive performance on Shifting Attention Test', 'timeFrame': '2 weeks', 'description': 'Assessed using the CNS Vital Signs computerized testing platform ("brain games"). CNS Vital Signs is a computerized neuropsychological/neurocognitive assessment platform used by clinicians and researchers to objectively evaluate brain function and neurocognitive status, offering a range of tests and tools for assessment and management of various neurological and behavioral conditions.'}, {'measure': 'Cognitive performance on Continuous Performance Test', 'timeFrame': 'Up to 4 weeks', 'description': 'Assessed using the CNS Vital Signs computerized testing platform ("brain games").'}, {'measure': 'Cognitive performance on Reasoning Test', 'timeFrame': '2 weeks', 'description': 'Assessed using the CNS Vital Signs computerized testing platform ("brain games"). CNS Vital Signs is a computerized neuropsychological/neurocognitive assessment platform used by clinicians and researchers to objectively evaluate brain function and neurocognitive status, offering a range of tests and tools for assessment and management of various neurological and behavioral conditions.'}, {'measure': 'Cognitive performance on Four Part Continuous Performance Test', 'timeFrame': '2 weeks', 'description': 'Assessed using the CNS Vital Signs computerized testing platform ("brain games"). CNS Vital Signs is a computerized neuropsychological/neurocognitive assessment platform used by clinicians and researchers to objectively evaluate brain function and neurocognitive status, offering a range of tests and tools for assessment and management of various neurological and behavioral conditions.'}, {'measure': 'Self-reported cognition - FACT-COG', 'timeFrame': '2 weeks', 'description': 'Evaluated using the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-COG), a 37-item questionnaire assessing cognitive impairment, cognitive abilities, and quality of life over the past 7 days. Responses are on a 5-point scale (Never; About once a week; Two to three times a week; Nearly every day; Several times a day). Higher scores generally indicate better self-reported cognition.'}, {'measure': 'Average weekly minutes of physical activity', 'timeFrame': '2 weeks', 'description': 'Moderate-to-vigorous physical activity (MVPA) will be measured using an accelerometer (activPAL) which participants will wear on their non-dominant thigh for 7 consecutive days.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cancer', 'adolescent', 'young adult', 'cognition', 'memory', 'exercise', 'physical activity'], 'conditions': ['Hematopoietic and Lymphatic System Neoplasm', 'Malignant Solid Neoplasm']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates relationships among physical activity, thinking, and memory after cancer treatment in survivors of adolescent and young adult cancers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with primary diagnosis of cancer when 15-39 years old.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults (aged 18+ years)\n* Primary diagnosis of cancer when 15-39 years-old\n* Access to a desktop computer or laptop with reliable internet access\n* No gross motor impairments that prohibit ambulation\n* Willing to complete study requirements\n* English speaking\n\nExclusion Criteria:\n\n* Diagnosed with nonmelanoma skin cancer only\n* Not diagnosed with cancer in adolescent and young adult (AYA) age range of 15-39 years\n* Scheduled travel during the study period that is not indicative of individual's normal schedule"}, 'identificationModule': {'nctId': 'NCT06880861', 'acronym': 'IMPACT', 'briefTitle': 'Investigating Memory and Physical Activity After Cancer Treatment in Survivors of Adolescent and Young Adult Cancers', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Investigating Memory and Physical Activity After Cancer Treatment in Survivors of Adolescent and Young Adult Cancers', 'orgStudyIdInfo': {'id': '24-008654'}, 'secondaryIdInfos': [{'id': 'NCI-2025-01193', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '24-008654', 'type': 'OTHER', 'domain': 'Mayo Clinic Institutional Review Board'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observational', 'description': 'Patients complete questionnaires and cognitive tasks and wear an activity monitor to measure physical activity on study. Some patients may optionally participate in an interview on study.', 'interventionNames': ['Other: Non-Interventional Study']}], 'interventions': [{'name': 'Non-Interventional Study', 'type': 'OTHER', 'description': 'Non-Interventional Study', 'armGroupLabels': ['Observational']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Melissa Cole', 'role': 'CONTACT', 'email': 'mailto:ARZENL@mayo.edu', 'phone': '480-574-4052'}, {'name': 'Clinical Trials Referral Office', 'role': 'CONTACT', 'email': 'mayocliniccancerstudies@mayo.edu', 'phone': '855-776-0015'}, {'name': 'Diane K. Ehlers, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic in Arizona', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}], 'centralContacts': [{'name': 'Melissa Cole', 'role': 'CONTACT', 'email': 'mailto:ARZENL@mayo.edu', 'phone': '480-574-4052'}, {'name': 'Clinical Trials Referral Office', 'role': 'CONTACT', 'email': 'mayocliniccancerstudies@mayo.edu', 'phone': '855-776-0015'}], 'overallOfficials': [{'name': 'Diane K. Ehlers, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'At time of first publication (as required by journals) until last manuscript is published.', 'ipdSharing': 'YES', 'description': 'De-identified, limited datasets will be shared with other researchers upon request or according to journal publication requirements', 'accessCriteria': 'If required by journal and case by case upon request to the PI'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}