Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2026-02-11 @ 4:39 AM
Study NCT ID:
NCT04257058
Status:
COMPLETED
Last Update Posted:
2025-05-15
First Post:
2020-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Education Tools to Support Pediatric Survivor Care
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jgillel@emory.edu', 'phone': '404-727-2293', 'title': 'Dr. Jordan Marchak', 'organization': 'Emory University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Information on adverse events was collected beginning at the time of the intervention and continuing through the end of the study, at 2 weeks post-intervention.', 'eventGroups': [{'id': 'EG000', 'title': 'Electronic Educational Material', 'description': 'Participants in the trial included young adult survivors of childhood cancer. Participants completed an online pre-test survey via REDCap. After the pre-test is completed, participants review electronic media in REDCap. Study staff confirmed review of material and scheduled a post-test survey to be competed in REDCap two weeks after material is reviewed.', 'otherNumAtRisk': 89, 'deathsNumAtRisk': 89, 'otherNumAffected': 0, 'seriousNumAtRisk': 89, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'seriousEvents': [{'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Survivor Care Knowledge Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Electronic Educational Material', 'description': 'Participants in the trial included young adult survivors of childhood cancer. Participants completed an online pre-test survey via REDCap. After the pre-test is completed, participants review electronic media in REDCap. Study staff confirmed review of material and scheduled a post-test survey to be competed in REDCap two weeks after material is reviewed.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.6', 'spread': '2.1', 'groupId': 'OG000'}]}]}, {'title': '2 weeks post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.2', 'spread': '2.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 2 weeks post-intervention', 'description': "Knowledge was assessed at baseline and 2 weeks post-intervention, with the Survivor Care Knowledge scale, that includes 15-item multiple-choice quiz to assess participants' knowledge of the content covered in the electronic educational materials previously provided. Total score ranges from 0-15. Higher score is associated with better outcome.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Total number of participants analyzed per time point include participants that completed the corresponding visit and the specific assessment for this study outcome.'}, {'type': 'SECONDARY', 'title': 'Benefits for Survivor Care', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Electronic Educational Material', 'description': 'Participants in the trial included young adult survivors of childhood cancer. Participants completed an online pre-test survey via REDCap. After the pre-test is completed, participants review electronic media in REDCap. Study staff confirmed review of material and scheduled a post-test survey to be competed in REDCap two weeks after material is reviewed.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12.6', 'spread': '1.9', 'groupId': 'OG000'}]}]}, {'title': '2 weeks post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12.9', 'spread': '1.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 2 weeks post-intervention', 'description': '5-item study adapted Champion Benefits Scale for Mammography Screening. Total score ranges from 5-25. Lower score equals fewer perceived benefits of survivor care.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Total number of participants analyzed per time point include participants that completed the corresponding visit and the specific assessment for this study outcome.'}, {'type': 'SECONDARY', 'title': 'Barriers for Survivor Care', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Electronic Educational Material', 'description': 'Participants in the trial included young adult survivors of childhood cancer. Participants completed an online pre-test survey via REDCap. After the pre-test is completed, participants review electronic media in REDCap. Study staff confirmed review of material and scheduled a post-test survey to be competed in REDCap two weeks after material is reviewed.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20.2', 'spread': '5.9', 'groupId': 'OG000'}]}]}, {'title': '2 weeks post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19.9', 'spread': '5.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 2 weeks post-intervention', 'description': '11-item study adapted Champion Barriers Scale for Mammography Screening. Total score ranges from 11-55. Lower score equals fewer perceived barriers to survivor care.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Total number of participants analyzed per time point include participants that completed the corresponding visit and the specific assessment for this study outcome.'}, {'type': 'SECONDARY', 'title': 'Perceived Susceptibility for Late Effects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Electronic Educational Material', 'description': 'Participants in the trial included young adult survivors of childhood cancer. Participants completed an online pre-test survey via REDCap. After the pre-test is completed, participants review electronic media in REDCap. Study staff confirmed review of material and scheduled a post-test survey to be competed in REDCap two weeks after material is reviewed.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.7', 'spread': '3.1', 'groupId': 'OG000'}]}]}, {'title': '2 weeks post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.4', 'spread': '2.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 2 weeks post-intervention', 'description': '3-item study adapted Champion Susceptibility Scale for Mammography Screening. Total score ranges from 3-15. Lower score equals less susceptibility to late effects of treatment.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Total number of participants analyzed per time point include participants that completed the corresponding visit and the specific assessment for this study outcome.'}, {'type': 'SECONDARY', 'title': 'Intentions for Survivor Care', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Electronic Educational Material', 'description': 'Participants in the trial included young adult survivors of childhood cancer. Participants completed an online pre-test survey via REDCap. After the pre-test is completed, participants review electronic media in REDCap. Study staff confirmed review of material and scheduled a post-test survey to be competed in REDCap two weeks after material is reviewed.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.8', 'spread': '3.4', 'groupId': 'OG000'}]}]}, {'title': '2 weeks post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.4', 'spread': '3.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 2 weeks post-intervention', 'description': "2-item study adapted Ajzen's Theory of Planned Behavior- Intentions. Total score ranges from 2-14. Lower score equals greater intention to engage in long-term follow-up care.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Total number of participants analyzed per time point include participants that completed the corresponding visit and the specific assessment for this study outcome.'}, {'type': 'SECONDARY', 'title': 'Change in Perceived Health Competence Scale (PHCS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Self-efficacy', 'description': 'Participants in the trial included young adult survivors of childhood cancer. Participants completed an online pre-test survey via REDCap. After the pre-test is completed, participants review electronic media in REDCap. Study staff confirmed review of material and scheduled a post-test survey to be competed in REDCap two weeks after material is reviewed.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '28.7', 'spread': '5.2', 'groupId': 'OG000'}]}]}, {'title': '2 weeks post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '27.0', 'spread': '5.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 2 weeks post-intervention', 'description': '8-item Perceived Health Competence Scale (PHCS). Total score ranges from 8-40. Lower score equals lower perceived health competence.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Total number of participants analyzed per time point include participants that completed the corresponding visit and the specific assessment for this study outcome.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Electronic Educational Material', 'description': 'Participants in the trial included young adult survivors of childhood cancer. Participants completed an online pre-test survey via REDCap. After the pre-test is completed, participants review electronic media in REDCap. Study staff confirmed review of material and scheduled a post-test survey to be competed in REDCap two weeks after material is reviewed.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '89'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '31'}]}]}], 'preAssignmentDetails': 'This study and the data presented below only refers to the young adult survivors and does not include parents. Parents were not enrolled in this study. "Participants" refer to young adult cancer survivors.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Electronic Educational Material', 'description': 'Participants in the trial included young adult survivors of childhood cancer. Participants completed an online pre-test survey via REDCap. After the pre-test is completed, participants review electronic media in REDCap. Study staff confirmed review of material and scheduled a post-test survey to be competed in REDCap two weeks after material is reviewed.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '19.8', 'spread': '1.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}]}]}, {'title': 'Non-Binary', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '63', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '56', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '89', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-10-18', 'size': 539948, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-03-18T16:10', 'hasProtocol': True}, {'date': '2023-07-11', 'size': 223798, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-07-09T15:05', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 89}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-04-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-14', 'studyFirstSubmitDate': '2020-02-04', 'resultsFirstSubmitDate': '2025-04-03', 'studyFirstSubmitQcDate': '2020-02-04', 'lastUpdatePostDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-14', 'studyFirstPostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survivor Care Knowledge Scale', 'timeFrame': 'Baseline, 2 weeks post-intervention', 'description': "Knowledge was assessed at baseline and 2 weeks post-intervention, with the Survivor Care Knowledge scale, that includes 15-item multiple-choice quiz to assess participants' knowledge of the content covered in the electronic educational materials previously provided. Total score ranges from 0-15. Higher score is associated with better outcome."}], 'secondaryOutcomes': [{'measure': 'Benefits for Survivor Care', 'timeFrame': 'Baseline, 2 weeks post-intervention', 'description': '5-item study adapted Champion Benefits Scale for Mammography Screening. Total score ranges from 5-25. Lower score equals fewer perceived benefits of survivor care.'}, {'measure': 'Barriers for Survivor Care', 'timeFrame': 'Baseline, 2 weeks post-intervention', 'description': '11-item study adapted Champion Barriers Scale for Mammography Screening. Total score ranges from 11-55. Lower score equals fewer perceived barriers to survivor care.'}, {'measure': 'Perceived Susceptibility for Late Effects', 'timeFrame': 'Baseline, 2 weeks post-intervention', 'description': '3-item study adapted Champion Susceptibility Scale for Mammography Screening. Total score ranges from 3-15. Lower score equals less susceptibility to late effects of treatment.'}, {'measure': 'Intentions for Survivor Care', 'timeFrame': 'Baseline, 2 weeks post-intervention', 'description': "2-item study adapted Ajzen's Theory of Planned Behavior- Intentions. Total score ranges from 2-14. Lower score equals greater intention to engage in long-term follow-up care."}, {'measure': 'Change in Perceived Health Competence Scale (PHCS)', 'timeFrame': 'Baseline, 2 weeks post-intervention', 'description': '8-item Perceived Health Competence Scale (PHCS). Total score ranges from 8-40. Lower score equals lower perceived health competence.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Behavioral study', 'Social study', 'Pediatric cancer'], 'conditions': ['Cancer', 'Pediatric Cancer']}, 'descriptionModule': {'briefSummary': "This study aims to evaluate the impact of electronic educational materials on adolescent and young adult (AYA) survivors' knowledge about late effects, perceived benefits, self-efficacy, and intentions to engage in lifelong survivor care.", 'detailedDescription': "Despite increased risk for morbidity and mortality related to cancer treatment, over half of young adult survivors of childhood cancer do not engage in the recommended healthcare designed to detect late effects and secondary cancers. There is a scarcity of data on adherence to survivor-focused healthcare, particularly at the critical transition from pediatrics to adult care. In order to improve transition outcomes, the investigators need to create media to educate survivors about need for adherence to adult survivor healthcare.\n\nThis study aims to evaluate the impact of electronic educational materials on AYA survivors' knowledge about late effects, perceived benefits, self-efficacy, and intentions to engage in lifelong survivor care."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must be 18-25 years of age,\n* Diagnosed with cancer at ≤ 18 years of age,\n* ≥ 2 years since the last cancer treatment,\n* seen at least once in the Aflac Cancer Survivor Program (CSP) in the past 2 years or transitioned out of the Aflac CSP to adult survivor care since 2013.\n\nExclusion Criteria:\n\n* Patients will be excluded from participation in the study if the participant is non-English speaking.\n* Young adult survivors who are cognitively impaired and unable to complete the questionnaires.\n* Participants that do not consent to the recording of their interviews.'}, 'identificationModule': {'nctId': 'NCT04257058', 'briefTitle': 'Education Tools to Support Pediatric Survivor Care', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': "Predicting Childhood Cancer Survivors' Transition Readiness & Transfer Outcomes (SURV Transfer Outcomes) (Administrative Supplement to R01CA218389)", 'orgStudyIdInfo': {'id': 'IRB00091839'}, 'secondaryIdInfos': [{'id': 'R01CA218389', 'link': 'https://reporter.nih.gov/quickSearch/R01CA218389', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Electronic educational material', 'description': 'Participants in the trial included young adult survivors of childhood cancer. Participants completed an online pre-test survey via REDCap. After the pre-test is completed, participants review electronic media in REDCap. Study staff confirmed review of material and scheduled a post-test survey to be competed in REDCap two weeks after material is reviewed.', 'interventionNames': ['Behavioral: Electronic educational material']}], 'interventions': [{'name': 'Electronic educational material', 'type': 'BEHAVIORAL', 'description': 'Electronic media via email', 'armGroupLabels': ['Electronic educational material']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Children's Healthcare of Atlanta", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Jordan Marchak, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jordan Marchak', 'investigatorAffiliation': 'Emory University'}}}}