Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2025-12-26 @ 3:31 AM
Study NCT ID:
NCT04611620
Status:
COMPLETED
Last Update Posted:
2023-02-22
First Post:
2020-10-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Biobehavioral Correlates of Cancer-related Cognitive Dysfunction and Its Co-occurring Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D020447', 'term': 'Parasomnias'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'The NIH NINR lab will run genome-wide sequencing per an approved and standardized protocol. In this study, we will focus on 3 genetic SNP variants of BDNF, APOE, and COMT (described previously). After final batch analyses, only outcome data with the unique identification numbers will be transferred via secure server to be linked back with the other survey and neuropsychological data.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 682}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2021-07-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-21', 'studyFirstSubmitDate': '2020-10-12', 'studyFirstSubmitQcDate': '2020-10-27', 'lastUpdatePostDateStruct': {'date': '2023-02-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subjective Cognitive Dysfunction', 'timeFrame': 'greater than or equal to 6 months post cancer treatment', 'description': 'PROMIS - Cognitive Abilities and Concerns'}], 'secondaryOutcomes': [{'measure': 'Objective Cognitive Dysfunction', 'timeFrame': 'greater than or equal to 6 months post cancer treatment', 'description': 'Visual Episodic Memory'}, {'measure': 'Objective Cognitive Dysfunction', 'timeFrame': 'greater than or equal to 6 months post cancer treatment', 'description': 'Working Memory'}, {'measure': 'Objective Cognitive Dysfunction', 'timeFrame': 'greater than or equal to 6 months post cancer treatment', 'description': 'Executive Functioning'}, {'measure': 'Objective Cognitive Dysfunction', 'timeFrame': 'greater than or equal to 6 months post cancer treatment', 'description': 'Sustained Attention'}, {'measure': 'Objective Cognitive Dysfunction', 'timeFrame': 'greater than or equal to 6 months post cancer treatment', 'description': 'Visuospatial Working Memory'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast Cancer and Colorectal Cancer', 'Co-Occurring Symptoms'], 'conditions': ['Survivorship', 'Cognitive Dysfunction', 'Pain', 'Depression', 'Anxiety', 'Fatigue', 'Sleep Disturbance']}, 'referencesModule': {'references': [{'pmid': '38379321', 'type': 'DERIVED', 'citation': 'Goto T, Saligan LN, Li X, Xiang L, Kwiat C, Nguyen C, Crouch A, Von Ah D. Associations of brain-derived neurotrophic factor rs6265 polymorphism and cognitive function in breast cancer survivors from a cross-sectional study. Cancer Med. 2024 Jan;13(2):e6975. doi: 10.1002/cam4.6975.'}, {'pmid': '37232534', 'type': 'DERIVED', 'citation': 'Storey S, Draucker C, Haunert L, Von Ah D. The Experience of Peripheral Neuropathy Symptoms in Breast Cancer Survivors With Diabetes. Cancer Nurs. 2024 Jul-Aug 01;47(4):E279-E286. doi: 10.1097/NCC.0000000000001253. Epub 2023 May 26.'}]}, 'descriptionModule': {'briefSummary': 'This descriptive, cross-sectional study will evaulate and fully characterize factors associated with cognitive dysfunction in Breast Cancer (BCS) and Colorectal Cancer (CRC) survivors that have cognitive concerns, and factors associated with psychoneurological symptom cluster in BCS and CRC survivors.', 'detailedDescription': 'Primary Aim: To identify demographic factors (age and education), medical and cancer treatment-related factors (comorbidities and treatment type), psychosocial factors (perceived stress, affect, optimism, coping, emotional support), cancer-related symptoms (pain, depression, anxiety, fatigue and sleep disturbance), and genetic factors (APOE, COMT, BDNF) associated with the level of subjective or the level of objective cognitive dysfunction in breast cancer and colorectal cancer survivors.\n\nSecondary Aim: To identify demographic factors (age and education), medical and cancer treatment-related factors (comorbidities and treatment type), psychosocial factors (perceived stress, affect, optimism, coping, emotional support), and genetic factors (APOE, COMT, BDNF) associated with psychoneurological symptom cluster using either subjective or objective cognitive dysfunction in breast cancer and colorectal cancer survivors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A total of 465 breast and colorectal cancer patients will be recruited for this study. Breast and colorectal cancer survivors.\n\nThe eligibility checklist is a self-report questionnaire. Participants will be asked to self-identify that they are 21 years of age or older, had been diagnosed with breast or colorectal cancer excluding Stage IV (those without distant metastasis) and have completed treatment (adjuvant or neo-adjuvant) at least 6 months prior to completing the survey. In addition, as part of the eligibility checklist, participants will need to self-rate that they have cognitive concerns (select yes).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nInclusion Criteria for Breast cancer survivors:\n\n1. Female BCS\n2. ≥ 21 years of age and older\n3. Ability to provide written consent and HIPAA authorization\n4. ≥6 months post-adjuvant therapy and neo-adjuvant therapy for early stage (Stage I-IIIA) breast cancer.\n\n Current Aromatase Inhibitors or Tamoxifen treatment at time of enrollment is allowed.\n5. Identify cognitive concerns (select yes)\n\nInclusion Criteria for Colorectal cancer survivors:\n\n1. Male or female CRC survivors\n2. Ability to provide written consent and HIPAA authorization\n3. ≥ 21 years of age and older\n4. ≥6 months post-adjuvant therapy and neo-adjuvant therapy for early stage (stage I-III) CRC\n5. Identify cognitive concerns (select yes)\n\nExclusion Criteria:\n\n1. Report metastatic breast or colorectal cancer (Stage IV) at time of consenting.\n2. Unable to read and understand English to complete survey questionnaires.'}, 'identificationModule': {'nctId': 'NCT04611620', 'briefTitle': 'Biobehavioral Correlates of Cancer-related Cognitive Dysfunction and Its Co-occurring Symptoms', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Biobehavioral Correlates of Cancer-related Cognitive Dysfunction and Its Co-occurring Symptoms', 'orgStudyIdInfo': {'id': 'NURS-IIR-IUSCCC-0748'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Breast Cancer and Colorectal Cancer Survivors', 'description': 'The purpose of this study is to explore the factors related with cognitive concerns and other symptoms in breast and colorectal cancer survivors.', 'interventionNames': ['Behavioral: Cognitive Dysfunction']}], 'interventions': [{'name': 'Cognitive Dysfunction', 'type': 'BEHAVIORAL', 'description': 'To fully characterize factors associated with cognitive dysfunction in BCS and CRC survivors that have cognitive concerns and (2) to fully characterize factors associated with psychoneurological symptom cluster in BCS and CRC survivors.', 'armGroupLabels': ['Breast Cancer and Colorectal Cancer Survivors']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'overallOfficials': [{'name': 'Diane Von Ah, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IU'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Dean of Academic Operations', 'investigatorFullName': 'Diane Von Ah', 'investigatorAffiliation': 'Indiana University'}}}}