Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2026-01-01 @ 7:25 PM
Study NCT ID:
NCT05258058
Status:
COMPLETED
Last Update Posted:
2024-07-10
First Post:
2022-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Feasibility of the Memory and Attention Adaptation-Training Geriatrics Intervention in Older Cancer Survivors With Mild Cognitive Impairment
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'allison_magnuson@urmc.rochester.edu', 'phone': '585-602-5085', 'title': 'Dr. Allison Magnuson', 'organization': 'University of Rochester'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '10 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'MAAT-G Intervention', 'description': 'MAAT-G Workshops \\& participant workbook use (8 workshops)\n\nMemory and Adaptation Training-Geriatrics: MAAT-G is a cognitive behavioral therapy-based intervention comprised of 10 workshop sessions as well as a participant workbook. The workshop sessions are delivered one on one by a health professional via videoconferencing technology.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'MAAT-G Feasibility Completion Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MAAT-G Intervention', 'description': 'MAAT-G Workshops \\& participant workbook use (10 workshops)\n\nMemory and Adaptation Training-Geriatrics: MAAT-G is a cognitive behavioral therapy-based intervention comprised of 10 workshop sessions as well as a participant workbook. The workshop sessions are delivered one on one by a health professional via videoconferencing technology.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '10 Weeks', 'description': 'Evaluate the feasibility of MAAT-G in older cancer survivors with mild cognitive impairment by determining study completion rate of this population.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients Who Described at Least One MAAT-G Skill', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MAAT-G Intervention', 'description': 'MAAT-G Workshops \\& participant workbook use (8 workshops)\n\nMemory and Adaptation Training-Geriatrics: MAAT-G is a cognitive behavioral therapy-based intervention comprised of 10 workshop sessions as well as a participant workbook. The workshop sessions are delivered one on one by a health professional via videoconferencing technology.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '10 Weeks', 'description': 'To obtain descriptive feedback on the usability of the intervention and guide further adaptation, qualitative interviews with patients and their caregivers (if available) will be conducted at completion of the intervention.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Two patients withdrew from the study and therefore not included in the population.'}, {'type': 'SECONDARY', 'title': 'Change in Cognitive Function (Pre-Post Changes Functional Assessment of Cancer Therapy-Cognition [FACT-Cog])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MAAT-G Intervention', 'description': 'MAAT-G Workshops \\& participant workbook use (10 workshops)\n\nMemory and Adaptation Training-Geriatrics: MAAT-G is a cognitive behavioral therapy-based intervention comprised of 10 workshop sessions as well as a participant workbook. The workshop sessions are delivered one on one by a health professional via videoconferencing technology.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.39', 'spread': '12.20', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 Weeks', 'description': 'Examine the pre-post change in perceived and objective cognitive function in older cancer survivors with MCI using the Functional Assessment of Cancer Therapy-Cognition (FACT-Cog version 2): a 37 item scale assessing perceived cognitive impairment (Total score range 0-185, higher score indicates better cognitive function). Mean change from baseline score is reported.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Two patients withdrew from the study and therefore not included in the population.'}, {'type': 'SECONDARY', 'title': 'Mean Usability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MAAT-G Intervention', 'description': 'MAAT-G Workshops \\& participant workbook use (10 workshops)\n\nMemory and Adaptation Training-Geriatrics: MAAT-G is a cognitive behavioral therapy-based intervention comprised of 10 workshop sessions as well as a participant workbook. The workshop sessions are delivered one on one by a health professional via videoconferencing technology.'}], 'classes': [{'categories': [{'measurements': [{'value': '78.75', 'spread': '15.332', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 Weeks', 'description': 'Enhance our understanding of the usability of a telehealth CRCD intervention (including barriers and facilitators) for older cancer survivors with MCI and the perceived MAAT-G intervention effect using the System Usability Scale (SUS) (a score on a 10-item scale, with a total score ranging from 0-100; a higher score corresponds to greater usability).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Two patients withdrew from the study and therefore not included in the population.'}, {'type': 'PRIMARY', 'title': 'MAAT-G Intervention Adherence Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}, {'units': 'workshops', 'counts': [{'value': '120', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MAAT-G Intervention', 'description': 'MAAT-G Workshops \\& participant workbook use (10 workshops)\n\nMemory and Adaptation Training-Geriatrics: MAAT-G is a cognitive behavioral therapy-based intervention comprised of 10 workshop sessions as well as a participant workbook. The workshop sessions are delivered one on one by a health professional via videoconferencing technology.'}], 'classes': [{'categories': [{'measurements': [{'value': '88.33', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '10 Weeks', 'description': 'Evaluate the feasibility of MAAT-G in older cancer survivors with mild cognitive impairment by determining the study intervention adherence rate of this population (proportion of MAAT-G workshops completed).', 'unitOfMeasure': 'percentage of workshops adhered to', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'workshops', 'denomUnitsSelected': 'workshops'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MAAT-G Intervention', 'description': 'MAAT-G Workshops \\& participant workbook use (10 workshops)\n\nMemory and Adaptation Training-Geriatrics: MAAT-G is a cognitive behavioral therapy-based intervention comprised of 10 workshop sessions as well as a participant workbook. The workshop sessions are delivered one on one by a health professional via videoconferencing technology.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'MAAT-G Intervention', 'description': 'MAAT-G Workshops \\& participant workbook use (8 workshops)\n\nMemory and Adaptation Training-Geriatrics: MAAT-G is a cognitive behavioral therapy-based intervention comprised of 10 workshop sessions as well as a participant workbook. The workshop sessions are delivered one on one by a health professional via videoconferencing technology.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '75.8', 'spread': '7.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-03-15', 'size': 945066, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-05-02T11:46', 'hasProtocol': True}, {'date': '2023-03-20', 'size': 625915, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-05-02T11:47', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2023-07-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-13', 'studyFirstSubmitDate': '2022-02-17', 'resultsFirstSubmitDate': '2024-05-02', 'studyFirstSubmitQcDate': '2022-02-17', 'lastUpdatePostDateStruct': {'date': '2024-07-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-06-13', 'studyFirstPostDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MAAT-G Feasibility Completion Rate', 'timeFrame': '10 Weeks', 'description': 'Evaluate the feasibility of MAAT-G in older cancer survivors with mild cognitive impairment by determining study completion rate of this population.'}, {'measure': 'MAAT-G Intervention Adherence Rate', 'timeFrame': '10 Weeks', 'description': 'Evaluate the feasibility of MAAT-G in older cancer survivors with mild cognitive impairment by determining the study intervention adherence rate of this population (proportion of MAAT-G workshops completed).'}], 'secondaryOutcomes': [{'measure': 'Proportion of Patients Who Described at Least One MAAT-G Skill', 'timeFrame': '10 Weeks', 'description': 'To obtain descriptive feedback on the usability of the intervention and guide further adaptation, qualitative interviews with patients and their caregivers (if available) will be conducted at completion of the intervention.'}, {'measure': 'Change in Cognitive Function (Pre-Post Changes Functional Assessment of Cancer Therapy-Cognition [FACT-Cog])', 'timeFrame': '10 Weeks', 'description': 'Examine the pre-post change in perceived and objective cognitive function in older cancer survivors with MCI using the Functional Assessment of Cancer Therapy-Cognition (FACT-Cog version 2): a 37 item scale assessing perceived cognitive impairment (Total score range 0-185, higher score indicates better cognitive function). Mean change from baseline score is reported.'}, {'measure': 'Mean Usability', 'timeFrame': '10 Weeks', 'description': 'Enhance our understanding of the usability of a telehealth CRCD intervention (including barriers and facilitators) for older cancer survivors with MCI and the perceived MAAT-G intervention effect using the System Usability Scale (SUS) (a score on a 10-item scale, with a total score ranging from 0-100; a higher score corresponds to greater usability).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cancer-related cognitive difficulties', 'mild cognitive impairment'], 'conditions': ['Cognitive Dysfunction']}, 'descriptionModule': {'briefSummary': 'Cancer-related cognitive dysfunction (CRCD) affects up to 75% of patients receiving chemotherapy and older adults are at greater risk of developing CRCD, which can negatively affect their functional independence and quality of life. Memory and Attention Adaptation Training-Geriatrics (MAAT-G) is a cognitive behavioral therapy-based intervention tailored specifically for older adults and the feasibility of MAAT-G in older cancer survivors with Mild Cognitive Impairment (MCI) is being evaluated.', 'detailedDescription': 'Cancer-related cognitive dysfunction (CRCD) affects up to 75% of patients receiving chemotherapy and older adults are at greater risk of developing CRCD, which can negatively affect their functional independence and quality of life. Memory and Attention Adaptation Training-Geriatrics (MAAT-G) is a cognitive behavioral therapy-based intervention tailored specifically for older adults. MAAT-G is a series of 10 workshops delivered by a trained health profession via videoconferencing technology. The feasibility of MAAT-G in older cancer survivors with Mild Cognitive Impairment (MCI) is being evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Be age 65 or older\n2. Able to provide informed consent. All patients will be assessed using the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC)56 - a score \\>14.5 will define ability to independently provide informed consent. For patients scoring \\<14.5, or if investigators have additional concerns, we will require that their health care proxy participate in the consenting process and sign an informed consent and patients will required to provide assent.\n3. Able to read and understand English\n4. Have a prior diagnosis of cancer and completed curative intent chemotherapy. Patients are permitted to be receiving maintenance therapy (e.g. endocrine therapy) in the adjuvant setting.\n5. Have a clinical diagnosis of MCI, a score \\<26 on the Montreal Cognitive Assessment (MOCA), or a score \\<18 on the Montreal Cognitive Assessment-BLIND (MOCA-BLIND). If the patient had a MOCA evaluation completed as a part of routine clinical care in the preceding 3 months prior to consent date, this may be used for eligibility purposes.\n6. Be independent in Activities of Daily Living (ADL)'}, 'identificationModule': {'nctId': 'NCT05258058', 'acronym': 'urochester', 'briefTitle': 'Feasibility of the Memory and Attention Adaptation-Training Geriatrics Intervention in Older Cancer Survivors With Mild Cognitive Impairment', 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': 'Mitigating Cancer-Related Cognitive Impairment in Older Adults With Cancer: Memory and Attention Adaptation Training-Geriatrics (MAAT-G) Phase I', 'orgStudyIdInfo': {'id': 'UCCS19102- Part 2'}, 'secondaryIdInfos': [{'id': 'K76AG064394-03S1', 'link': 'https://reporter.nih.gov/quickSearch/K76AG064394-03S1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MAAT-G Intervention', 'description': 'MAAT-G Workshops \\& participant workbook use (8 workshops)', 'interventionNames': ['Behavioral: Memory and Adaptation Training-Geriatrics']}], 'interventions': [{'name': 'Memory and Adaptation Training-Geriatrics', 'type': 'BEHAVIORAL', 'otherNames': ['MAAT-G'], 'description': 'MAAT-G is a cognitive behavioral therapy-based intervention comprised of 10 workshop sessions as well as a participant workbook. The workshop sessions are delivered one on one by a health professional via videoconferencing technology.', 'armGroupLabels': ['MAAT-G Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}], 'overallOfficials': [{'name': 'Allison Magnuson', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Univ. of Rochester Wilmot Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allison Magnuson', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor - Department of Medicine , Hematology/Oncology (SMD)', 'investigatorFullName': 'Allison Magnuson', 'investigatorAffiliation': 'University of Rochester'}}}}